Global Shortage of Innovative Antibiotics Fuels Spread of Drug-Resistance, Says New Report 16/04/2021 Raisa Santos No new medicine is in the development pipeline to combat antimicrobial resistance. Despite growing awareness of the urgent threat of antibiotic resistance, the world is still failing to develop needed antibacterial treats, according to a new report by the World Health Organization (WHO). Of the 43 antibiotics and 27 non-traditional antibacterial agents in the current clinical antibacterial pipeline, none is sufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance (AMR). The persistent failure to develop, manufacture, and distribute effective new antibiotics is further fueling the impact of antimicrobial resistance and threatens our ability to successfully treat bacterial infections,” said Dr Hanan Balkhy, WHO Assistant Director General on AMR. WHO’s annual Antibacterial Pipeline Report reviews antibiotics that are in the clinical stages of testing as well as those in early product development. The aim is to assess and identify gaps in relation to urgent threats of drug resistance, and encourage action to fill those gaps. The report evaluates the potential of the candidates to address the most threatening drug-resistance bacteria, as outlined in the WHO Bacterial Priority Pathogens list, which includes 13 priority drug-resistant bacteria, including Mycobacterium tuberculosis and Clostridioides. Static Antibiotic Pipeline The 2020 Report reveals a near static development pipeline, with only a few antibiotics approved by regulatory agencies in recent years. Of the 43 antibiotics, 26 are active against WHO priority pathogens, 12 against M. tuberculosis and five against C.difficile. Eleven new antibiotics have either been approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), since 1 July 2017. However, the newly approved antibiotics have limited clinical benefit over existing treatment, as over 80% of them are from pre-existing classes where resistance is well-known Of the traditional antibacterials, only three new products entered the clinical pipeline while seven were discontinued or do not have any recent information. For the preclinical antibacterial pipeline, there are currently 292 diverse antibacterial agents in progress with commercial and non-commercial entities. Novel Solutions and Global Initiatives Needed The lack of progress on antibiotic development highlights the need to explore more innovative approaches to treat bacterial infections. While the COVID-19 crisis accentuated the gaps in sustainable funding to address the health and economic implications of an uncontrolled pandemic, it also revealed the opportunity that exists when there is both political will and enterprise. “Opportunities emerging from the COVID 19 pandemic must be seized to bring to the forefront the needs for sustainable investments in R&D o f new and effective antibiotics, said Haileyesus Getahun, Director of AMR Global Coordination at WHO. “Antibiotics present the Achilles heel for universal health coverage and our global health security. We need a global sustained effort including mechanisms for pooled funding and new and additional investments to meet the magnitude of the AMR threat.” Several global initiatives have been created to address gaps in funding in antibiotics development. WHO and its partner Drugs for Neglected Diseases Initiative (DNDi) have set up the Global Antibiotic R&D Partnership (GARDP). In addition, WHO is working closely with non-profits such as the United States-based Combating Antibiotic-Resistant Bacteria (CARB-X) to accelerate antibacterial research. There is also the AMR Action Fund, a partnership set up by pharmaceutical companies, philanthropies, the European Investment Bank, with the support of the WHO, that aims to strengthen and accelerate antibiotic development through global pooled funding. Image Credits: Interpol, Shutterstock. Kenya’s COVID-19 Vaccine Rollout: All Ready to Go, But No Doses Available 16/04/2021 Geoffrey Kamadi COVAX delivery of COVID-19 vaccines to Africa has been hampered by a shortage of vaccines. NAIROBI – Kenya has developed an ambitious COVID-19 vaccination rollout plan – but it has only received enough doses for a million of its 50 million citizens, and dispensed slightly more than half of these – 565,000 – to health workers. Kenya is currently in the third wave of the pandemic and estimates that 4 million people – healthworkers and elderly people – need to be vaccinated urgently during its first rollout phase. At the core of the country’s rollout plan is an online registration platform known as Chanjo-Ke (Chanjo is Swahili for immunization). The platform became operational in early April and it is intended to reduce the crowd numbers in vaccination centers all over the country. “The system will help us ensure that we are able to account for the vaccines as well as trace those who have been vaccinated and, in the end, certificates of vaccination will be issued based on data that will have been captured by the system,” explains Dr Willis Akhwale, chairperson of the Taskforce on Deployment of Vaccines in Kenya. The taskforce was created to advise the government on the vaccine rollout, and oversee its coordination. People seeking vaccination can register for the service in advance, choosing a day and a centre for the vaccination, then show up with a national and job ID at the station. The recipient will be reminded to come for the second dose via the system. Given the sensitive nature of personal medical data, the ICT Authority had to be brought in to ensure protection of this data, in accordance with the laws of Kenya. The Ministry of Health (MoH) and the National Treasury (Ministry of Finance) have asked the Africa Centers for Disease Control (CDC) for assistance in procuring more vaccines. Expansion of Vaccination Centres The government will also add another 1000 vaccination points to the current 658 and private healthcare facilities will add 2,500 facilities during the second phase of the vaccination exercise, set to begin in July. Ultimately, almost 8,000 facilities will be vaccinating people by phase three, according to Akhwale. “These facilities have been inspected and certified to have the right infrastructure and monitoring capabilities so that we can continuously vouch for safe vaccination,” adds Dr Collins Tabu, the head of Immunization and Vaccine Programme in the Ministry of Health. Certification of facilities is conducted by the Kenya Medical Practitioners and Dentists’ Council. At the moment, the country has been averaging 15,000 daily vaccinations, “which could easily get over 50-60,000 vaccinations per day if 300 facilities were fully vaccinating,” says Akwale. The whole deployment exercise is scheduled to run for 30 months and cover 60% of the adult population. The rest, including pregnant women and individuals under 18 years, are not targeted because as Akhwale explains, no vaccine for this population group exists at the moment. Gavi, the Vaccine Alliance, is donating 20 billion Kenya Shillings ($ 188 million) whereas the Kenyan Government will contribute 14 billion Shillings ($132 million) towards these efforts. However, Akhwale is quick to add that this will be contingent upon vaccine availability. The vaccines have emergency use authorization, given the urgency of the pandemic. This means that the vaccine use has not gone through the usual, lengthy stringent vetting process. Even so, the vaccine is not exempt from the monitoring rigours that come with the introduction of such a new product into the population. “The healthcare worker will key in the data into the Chanjo system in case of any adverse events following immunisation, and this data is channelled to the Pharmacovigilance Centre at the Pharmacy and Poisons Board,” says Dr Peter Mbuiru, acting Chief Principal Regulatory Officer at the Pharmacy and Poisons Board. The board has been active in both the control of the Covid-19 disease by developing key guidelines on the use of medical products and technologies including Covid-19 vaccines as well as the authorization of in vitro diagnosis used in testing the disease. About 3,000 healthcare workers have been trained to administer Covid-19 vaccines, with an additional 700 trainer-of-trainers having received training. Prioritisation of Target Groups Kenya is already battling a third wave of the pandemic. One of the biggest challenges in all this effort has been the prioritization of the target groups to receive the jab. The government’s initial target was to vaccinate 1.25 million frontline healthcare workers. However, Akhwale maintains that given older people were at higher risk of severe disease, this had to be expanded to include those aged 58 years and above. The population of this category of people is 2.7million in Kenya. This means that nearly 4 million people are most at-risk – but only 1million vaccine doses currently. So, given this difficult situation, can’t the government make its own bilateral arrangement to acquire doses outside the COVAX mechanism? “Yes, we can, but you need to understand at this time there are no vaccines out there,” Akhwale told Health Policy Watch. “Secondly, COVAX and the Africa CDC have already placed massive [vaccine] orders.” The only other option is to procure COVID-19 vaccines that are not WHO-approved, something which the country is not prepared to do. And in any case, adds Tabu of the Immunisation Programme, “the first dose will still provide protection of more than 76% until you receive the second dose.” The AstraZeneca vaccine, which Kenya is using, has raised some health safety concerns in some regions of the world, especially in Europe. “The question is, are these concerns directly related to the vaccine and are they significant enough to stop the benefits of vaccination over the risks that they may cause?” asked Dr Githinji Gitahi, CEO of Amref Health Africa, in a recent television interview, adding that the advice of the Africa CDC and WHO is that, “we should continue vaccinating.” One of the reasons why Kenya settled on AstraZeneca as opposed to other vaccines, according to Tabu, is the guaranteed availability of the vaccine despite the current constraints in the global supply chain. Image Credits: WHO. Unitaid Commemorates World Chagas Day With New Initiative To Prevent Mother-To-Child Transmission 15/04/2021 Editorial team World Chagas Day 2021 In commemoration of World Chagas Disease Day, Unitaid and the Brazilian Ministry of Health launched a $19 million initiative to expand access to affordable diagnostics and treatments for women and newborns in four Latin American countries where Chagas disease is endemic – Brazil, Bolivia, Colombia, and Paraguay. Transmitted by the blood-sucking triatomine bug called Trypanosoma cruzi, Chagas disease kills 10,000 people annually. In Latin America, it kills more people than any other parasitic disease including malaria. But only 7% of people with Chagas are diagnosed and only 1% receive appropriate care. If left untreated, Chagas can cause serious heart and digestive complications. Given that mother-to-child transmission is one of the key transmission pathways for the disease, vector control, active screening, and appropriate treatment options for women of childbearing age and their children represent crucial strategies to reducing new infections, said PAHO’s Director Carissa F. Etienne on Wednesday. “Chagas disease continues to generate much suffering and death for thousands of people in Latin America, especially in the poorer countries and among the most vulnerable populations,” she said at a press conference. “Mother-to-child transmission of Chagas can be prevented. We hope that this new global initiative will significantly advance efforts to ensure that every child in Bolivia, Brazil, Colombia and Paraguay is born free of Chagas disease.” The joint initiative will collaborate closely with regional and global partners, including the WHO and the Pan American Health Organization (PAHO). Read the Unitaid press release here. Image Credits: Unitaid. Gavi Receives $400 Million in Donations at High-Level Event To Expand Global Access to COVID-19 Vaccines 15/04/2021 Editorial team In a vital step forward that will help accelerate global access to COVID-19 vaccines, Gavi, the vaccine alliance raised some $400 million in donations at a high-level event on Thursday, just a week after the global COVAX facility reached 100 countries with almost 40 million vaccine doses. The event was hosted by US Secretary of State Antony J. Blinken, Acting Administrator of USAID Gloria Steele, and Chair of the Board of Gavi José Manuel Barroso, and saw pledges from Sweden, Netherlands, Lichtenstein and Portugal, as well as big donations from the Bill and Melinda Gates Foundation, Gates Philanthropy Partners, and Google. “COVAX represents our best way of ending the pandemic by ensuring equitable global access to safe and effective vaccines,” said Per Olsson Fridh, Sweden’s Minister for International Development Cooperation. “Already reaching over 100 countries, COVAX also shows what we can achieve by working together – from scientists and manufacturers to governments and multilateral organizations, to health workers around the globe. This is an investment not only in global solidarity, but also in our common objective of putting an end to the pandemic. The bulk of the money will go towards Gavi’s Advanced Market Commitment, which UNICEF Executive Director Henrietta Fore called a beacon of hope. “It’s [the AMC] an effective, realistic way to ensure fair and affordable access to vaccines for all,” she said at the high-level event on Thursday. “But getting vaccines off the tarmac and delivered to difficult-to-reach populations requires concerted, coordinated effort and dedicated funding,” said Fore. On another encouraging note, France and New Zealand committed to donating 13 million and 1.6 million surplus doses to COVAX – although Gavi expects “much larger” donations of suprlus doses in the future, added GAVI’s CEO Seth Berkley on Thursday. So far, COVAX has supplied 113 countries with over than 39.5 million vaccine doses, according to UNICEF’s COVID-19 Vaccine Market Dashboard. The global vaccine facility has already enabled access to the following vaccines: AstraZeneca/Oxford (via AstraZeneca and India’s Serum Institute) – up to 1.27 billion doses Pfizer-BionTech – 40 million doses Johnson & Johnson – 500 million doses Novavax – 1.1 billion doses Sanofi/GSK – 200 million doses Read Gavi’s full press release here. Image Credits: Global Fund/Vincent Becker. Growing Consensus Emerging At WTO – Strengthen Supply Chain & Tech Transfer To Expand Vaccine Access 15/04/2021 Svĕt Lustig Vijay WTO Headquarters in Geneva A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. “The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday. “As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” Broader Technology Transfer in Poorer Countries is Possible, Says Iweala Ngozi Okonjo-Iweala, WTO’s newly elected Director-General While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months. “One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said. However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains. Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added. Terrific conference yesterday on solving the problem of inequity in access to vaccines – so no one has to stand in line. Grateful to all the participants; governments, international orgs, vaccine manufacturers, and CSOs! Lots of learning, lot’s of concrete follow up action! https://t.co/YRW1Y1ESf0 — Ngozi Okonjo-Iweala (@NOIweala) April 15, 2021 Discussions On Intellectual Property Waiver Have “Advanced Knowledge” Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS). Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom, United States, Switzerland, and Japan. Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. “Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.” Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules. Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures: Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.” “There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said. “WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.” “And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.” As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. Image Credits: @WTO/Bryan Lehmann. Many Africans May Not Receive Their Second COVID-19 Vaccine Doses Anytime Soon, Africa CDC Warns 15/04/2021 Paul Adepoju Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses. While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus, Dr John Nkengasong, Director of the Africa CDC said while addressing a Thursday morning press briefing. “We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said. At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients. Dr Richard Mihigo “African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon. “I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. Wakeup Call for Africa Prof Oyewale Tomori Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources. “We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. “Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of the rest of the world. We’ve been in this position for too long,” Tomori said. South Africa, DRC to Resume COVID-19 Vaccinations Dr Boitumelo Semete There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing. But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations. “We anticipate the pause will be lifted in a couple of days to come,” Semete said. Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April. “The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said. By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT). Image Credits: Paul Adepoju, Paul Adepoju . WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Kenya’s COVID-19 Vaccine Rollout: All Ready to Go, But No Doses Available 16/04/2021 Geoffrey Kamadi COVAX delivery of COVID-19 vaccines to Africa has been hampered by a shortage of vaccines. NAIROBI – Kenya has developed an ambitious COVID-19 vaccination rollout plan – but it has only received enough doses for a million of its 50 million citizens, and dispensed slightly more than half of these – 565,000 – to health workers. Kenya is currently in the third wave of the pandemic and estimates that 4 million people – healthworkers and elderly people – need to be vaccinated urgently during its first rollout phase. At the core of the country’s rollout plan is an online registration platform known as Chanjo-Ke (Chanjo is Swahili for immunization). The platform became operational in early April and it is intended to reduce the crowd numbers in vaccination centers all over the country. “The system will help us ensure that we are able to account for the vaccines as well as trace those who have been vaccinated and, in the end, certificates of vaccination will be issued based on data that will have been captured by the system,” explains Dr Willis Akhwale, chairperson of the Taskforce on Deployment of Vaccines in Kenya. The taskforce was created to advise the government on the vaccine rollout, and oversee its coordination. People seeking vaccination can register for the service in advance, choosing a day and a centre for the vaccination, then show up with a national and job ID at the station. The recipient will be reminded to come for the second dose via the system. Given the sensitive nature of personal medical data, the ICT Authority had to be brought in to ensure protection of this data, in accordance with the laws of Kenya. The Ministry of Health (MoH) and the National Treasury (Ministry of Finance) have asked the Africa Centers for Disease Control (CDC) for assistance in procuring more vaccines. Expansion of Vaccination Centres The government will also add another 1000 vaccination points to the current 658 and private healthcare facilities will add 2,500 facilities during the second phase of the vaccination exercise, set to begin in July. Ultimately, almost 8,000 facilities will be vaccinating people by phase three, according to Akhwale. “These facilities have been inspected and certified to have the right infrastructure and monitoring capabilities so that we can continuously vouch for safe vaccination,” adds Dr Collins Tabu, the head of Immunization and Vaccine Programme in the Ministry of Health. Certification of facilities is conducted by the Kenya Medical Practitioners and Dentists’ Council. At the moment, the country has been averaging 15,000 daily vaccinations, “which could easily get over 50-60,000 vaccinations per day if 300 facilities were fully vaccinating,” says Akwale. The whole deployment exercise is scheduled to run for 30 months and cover 60% of the adult population. The rest, including pregnant women and individuals under 18 years, are not targeted because as Akhwale explains, no vaccine for this population group exists at the moment. Gavi, the Vaccine Alliance, is donating 20 billion Kenya Shillings ($ 188 million) whereas the Kenyan Government will contribute 14 billion Shillings ($132 million) towards these efforts. However, Akhwale is quick to add that this will be contingent upon vaccine availability. The vaccines have emergency use authorization, given the urgency of the pandemic. This means that the vaccine use has not gone through the usual, lengthy stringent vetting process. Even so, the vaccine is not exempt from the monitoring rigours that come with the introduction of such a new product into the population. “The healthcare worker will key in the data into the Chanjo system in case of any adverse events following immunisation, and this data is channelled to the Pharmacovigilance Centre at the Pharmacy and Poisons Board,” says Dr Peter Mbuiru, acting Chief Principal Regulatory Officer at the Pharmacy and Poisons Board. The board has been active in both the control of the Covid-19 disease by developing key guidelines on the use of medical products and technologies including Covid-19 vaccines as well as the authorization of in vitro diagnosis used in testing the disease. About 3,000 healthcare workers have been trained to administer Covid-19 vaccines, with an additional 700 trainer-of-trainers having received training. Prioritisation of Target Groups Kenya is already battling a third wave of the pandemic. One of the biggest challenges in all this effort has been the prioritization of the target groups to receive the jab. The government’s initial target was to vaccinate 1.25 million frontline healthcare workers. However, Akhwale maintains that given older people were at higher risk of severe disease, this had to be expanded to include those aged 58 years and above. The population of this category of people is 2.7million in Kenya. This means that nearly 4 million people are most at-risk – but only 1million vaccine doses currently. So, given this difficult situation, can’t the government make its own bilateral arrangement to acquire doses outside the COVAX mechanism? “Yes, we can, but you need to understand at this time there are no vaccines out there,” Akhwale told Health Policy Watch. “Secondly, COVAX and the Africa CDC have already placed massive [vaccine] orders.” The only other option is to procure COVID-19 vaccines that are not WHO-approved, something which the country is not prepared to do. And in any case, adds Tabu of the Immunisation Programme, “the first dose will still provide protection of more than 76% until you receive the second dose.” The AstraZeneca vaccine, which Kenya is using, has raised some health safety concerns in some regions of the world, especially in Europe. “The question is, are these concerns directly related to the vaccine and are they significant enough to stop the benefits of vaccination over the risks that they may cause?” asked Dr Githinji Gitahi, CEO of Amref Health Africa, in a recent television interview, adding that the advice of the Africa CDC and WHO is that, “we should continue vaccinating.” One of the reasons why Kenya settled on AstraZeneca as opposed to other vaccines, according to Tabu, is the guaranteed availability of the vaccine despite the current constraints in the global supply chain. Image Credits: WHO. Unitaid Commemorates World Chagas Day With New Initiative To Prevent Mother-To-Child Transmission 15/04/2021 Editorial team World Chagas Day 2021 In commemoration of World Chagas Disease Day, Unitaid and the Brazilian Ministry of Health launched a $19 million initiative to expand access to affordable diagnostics and treatments for women and newborns in four Latin American countries where Chagas disease is endemic – Brazil, Bolivia, Colombia, and Paraguay. Transmitted by the blood-sucking triatomine bug called Trypanosoma cruzi, Chagas disease kills 10,000 people annually. In Latin America, it kills more people than any other parasitic disease including malaria. But only 7% of people with Chagas are diagnosed and only 1% receive appropriate care. If left untreated, Chagas can cause serious heart and digestive complications. Given that mother-to-child transmission is one of the key transmission pathways for the disease, vector control, active screening, and appropriate treatment options for women of childbearing age and their children represent crucial strategies to reducing new infections, said PAHO’s Director Carissa F. Etienne on Wednesday. “Chagas disease continues to generate much suffering and death for thousands of people in Latin America, especially in the poorer countries and among the most vulnerable populations,” she said at a press conference. “Mother-to-child transmission of Chagas can be prevented. We hope that this new global initiative will significantly advance efforts to ensure that every child in Bolivia, Brazil, Colombia and Paraguay is born free of Chagas disease.” The joint initiative will collaborate closely with regional and global partners, including the WHO and the Pan American Health Organization (PAHO). Read the Unitaid press release here. Image Credits: Unitaid. Gavi Receives $400 Million in Donations at High-Level Event To Expand Global Access to COVID-19 Vaccines 15/04/2021 Editorial team In a vital step forward that will help accelerate global access to COVID-19 vaccines, Gavi, the vaccine alliance raised some $400 million in donations at a high-level event on Thursday, just a week after the global COVAX facility reached 100 countries with almost 40 million vaccine doses. The event was hosted by US Secretary of State Antony J. Blinken, Acting Administrator of USAID Gloria Steele, and Chair of the Board of Gavi José Manuel Barroso, and saw pledges from Sweden, Netherlands, Lichtenstein and Portugal, as well as big donations from the Bill and Melinda Gates Foundation, Gates Philanthropy Partners, and Google. “COVAX represents our best way of ending the pandemic by ensuring equitable global access to safe and effective vaccines,” said Per Olsson Fridh, Sweden’s Minister for International Development Cooperation. “Already reaching over 100 countries, COVAX also shows what we can achieve by working together – from scientists and manufacturers to governments and multilateral organizations, to health workers around the globe. This is an investment not only in global solidarity, but also in our common objective of putting an end to the pandemic. The bulk of the money will go towards Gavi’s Advanced Market Commitment, which UNICEF Executive Director Henrietta Fore called a beacon of hope. “It’s [the AMC] an effective, realistic way to ensure fair and affordable access to vaccines for all,” she said at the high-level event on Thursday. “But getting vaccines off the tarmac and delivered to difficult-to-reach populations requires concerted, coordinated effort and dedicated funding,” said Fore. On another encouraging note, France and New Zealand committed to donating 13 million and 1.6 million surplus doses to COVAX – although Gavi expects “much larger” donations of suprlus doses in the future, added GAVI’s CEO Seth Berkley on Thursday. So far, COVAX has supplied 113 countries with over than 39.5 million vaccine doses, according to UNICEF’s COVID-19 Vaccine Market Dashboard. The global vaccine facility has already enabled access to the following vaccines: AstraZeneca/Oxford (via AstraZeneca and India’s Serum Institute) – up to 1.27 billion doses Pfizer-BionTech – 40 million doses Johnson & Johnson – 500 million doses Novavax – 1.1 billion doses Sanofi/GSK – 200 million doses Read Gavi’s full press release here. Image Credits: Global Fund/Vincent Becker. Growing Consensus Emerging At WTO – Strengthen Supply Chain & Tech Transfer To Expand Vaccine Access 15/04/2021 Svĕt Lustig Vijay WTO Headquarters in Geneva A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. “The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday. “As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” Broader Technology Transfer in Poorer Countries is Possible, Says Iweala Ngozi Okonjo-Iweala, WTO’s newly elected Director-General While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months. “One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said. However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains. Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added. Terrific conference yesterday on solving the problem of inequity in access to vaccines – so no one has to stand in line. Grateful to all the participants; governments, international orgs, vaccine manufacturers, and CSOs! Lots of learning, lot’s of concrete follow up action! https://t.co/YRW1Y1ESf0 — Ngozi Okonjo-Iweala (@NOIweala) April 15, 2021 Discussions On Intellectual Property Waiver Have “Advanced Knowledge” Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS). Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom, United States, Switzerland, and Japan. Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. “Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.” Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules. Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures: Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.” “There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said. “WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.” “And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.” As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. Image Credits: @WTO/Bryan Lehmann. Many Africans May Not Receive Their Second COVID-19 Vaccine Doses Anytime Soon, Africa CDC Warns 15/04/2021 Paul Adepoju Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses. While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus, Dr John Nkengasong, Director of the Africa CDC said while addressing a Thursday morning press briefing. “We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said. At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients. Dr Richard Mihigo “African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon. “I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. Wakeup Call for Africa Prof Oyewale Tomori Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources. “We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. “Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of the rest of the world. We’ve been in this position for too long,” Tomori said. South Africa, DRC to Resume COVID-19 Vaccinations Dr Boitumelo Semete There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing. But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations. “We anticipate the pause will be lifted in a couple of days to come,” Semete said. Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April. “The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said. By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT). Image Credits: Paul Adepoju, Paul Adepoju . WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Unitaid Commemorates World Chagas Day With New Initiative To Prevent Mother-To-Child Transmission 15/04/2021 Editorial team World Chagas Day 2021 In commemoration of World Chagas Disease Day, Unitaid and the Brazilian Ministry of Health launched a $19 million initiative to expand access to affordable diagnostics and treatments for women and newborns in four Latin American countries where Chagas disease is endemic – Brazil, Bolivia, Colombia, and Paraguay. Transmitted by the blood-sucking triatomine bug called Trypanosoma cruzi, Chagas disease kills 10,000 people annually. In Latin America, it kills more people than any other parasitic disease including malaria. But only 7% of people with Chagas are diagnosed and only 1% receive appropriate care. If left untreated, Chagas can cause serious heart and digestive complications. Given that mother-to-child transmission is one of the key transmission pathways for the disease, vector control, active screening, and appropriate treatment options for women of childbearing age and their children represent crucial strategies to reducing new infections, said PAHO’s Director Carissa F. Etienne on Wednesday. “Chagas disease continues to generate much suffering and death for thousands of people in Latin America, especially in the poorer countries and among the most vulnerable populations,” she said at a press conference. “Mother-to-child transmission of Chagas can be prevented. We hope that this new global initiative will significantly advance efforts to ensure that every child in Bolivia, Brazil, Colombia and Paraguay is born free of Chagas disease.” The joint initiative will collaborate closely with regional and global partners, including the WHO and the Pan American Health Organization (PAHO). Read the Unitaid press release here. Image Credits: Unitaid. Gavi Receives $400 Million in Donations at High-Level Event To Expand Global Access to COVID-19 Vaccines 15/04/2021 Editorial team In a vital step forward that will help accelerate global access to COVID-19 vaccines, Gavi, the vaccine alliance raised some $400 million in donations at a high-level event on Thursday, just a week after the global COVAX facility reached 100 countries with almost 40 million vaccine doses. The event was hosted by US Secretary of State Antony J. Blinken, Acting Administrator of USAID Gloria Steele, and Chair of the Board of Gavi José Manuel Barroso, and saw pledges from Sweden, Netherlands, Lichtenstein and Portugal, as well as big donations from the Bill and Melinda Gates Foundation, Gates Philanthropy Partners, and Google. “COVAX represents our best way of ending the pandemic by ensuring equitable global access to safe and effective vaccines,” said Per Olsson Fridh, Sweden’s Minister for International Development Cooperation. “Already reaching over 100 countries, COVAX also shows what we can achieve by working together – from scientists and manufacturers to governments and multilateral organizations, to health workers around the globe. This is an investment not only in global solidarity, but also in our common objective of putting an end to the pandemic. The bulk of the money will go towards Gavi’s Advanced Market Commitment, which UNICEF Executive Director Henrietta Fore called a beacon of hope. “It’s [the AMC] an effective, realistic way to ensure fair and affordable access to vaccines for all,” she said at the high-level event on Thursday. “But getting vaccines off the tarmac and delivered to difficult-to-reach populations requires concerted, coordinated effort and dedicated funding,” said Fore. On another encouraging note, France and New Zealand committed to donating 13 million and 1.6 million surplus doses to COVAX – although Gavi expects “much larger” donations of suprlus doses in the future, added GAVI’s CEO Seth Berkley on Thursday. So far, COVAX has supplied 113 countries with over than 39.5 million vaccine doses, according to UNICEF’s COVID-19 Vaccine Market Dashboard. The global vaccine facility has already enabled access to the following vaccines: AstraZeneca/Oxford (via AstraZeneca and India’s Serum Institute) – up to 1.27 billion doses Pfizer-BionTech – 40 million doses Johnson & Johnson – 500 million doses Novavax – 1.1 billion doses Sanofi/GSK – 200 million doses Read Gavi’s full press release here. Image Credits: Global Fund/Vincent Becker. Growing Consensus Emerging At WTO – Strengthen Supply Chain & Tech Transfer To Expand Vaccine Access 15/04/2021 Svĕt Lustig Vijay WTO Headquarters in Geneva A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. “The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday. “As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” Broader Technology Transfer in Poorer Countries is Possible, Says Iweala Ngozi Okonjo-Iweala, WTO’s newly elected Director-General While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months. “One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said. However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains. Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added. Terrific conference yesterday on solving the problem of inequity in access to vaccines – so no one has to stand in line. Grateful to all the participants; governments, international orgs, vaccine manufacturers, and CSOs! Lots of learning, lot’s of concrete follow up action! https://t.co/YRW1Y1ESf0 — Ngozi Okonjo-Iweala (@NOIweala) April 15, 2021 Discussions On Intellectual Property Waiver Have “Advanced Knowledge” Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS). Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom, United States, Switzerland, and Japan. Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. “Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.” Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules. Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures: Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.” “There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said. “WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.” “And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.” As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. Image Credits: @WTO/Bryan Lehmann. Many Africans May Not Receive Their Second COVID-19 Vaccine Doses Anytime Soon, Africa CDC Warns 15/04/2021 Paul Adepoju Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses. While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus, Dr John Nkengasong, Director of the Africa CDC said while addressing a Thursday morning press briefing. “We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said. At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients. Dr Richard Mihigo “African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon. “I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. Wakeup Call for Africa Prof Oyewale Tomori Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources. “We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. “Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of the rest of the world. We’ve been in this position for too long,” Tomori said. South Africa, DRC to Resume COVID-19 Vaccinations Dr Boitumelo Semete There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing. But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations. “We anticipate the pause will be lifted in a couple of days to come,” Semete said. Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April. “The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said. By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT). Image Credits: Paul Adepoju, Paul Adepoju . WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Gavi Receives $400 Million in Donations at High-Level Event To Expand Global Access to COVID-19 Vaccines 15/04/2021 Editorial team In a vital step forward that will help accelerate global access to COVID-19 vaccines, Gavi, the vaccine alliance raised some $400 million in donations at a high-level event on Thursday, just a week after the global COVAX facility reached 100 countries with almost 40 million vaccine doses. The event was hosted by US Secretary of State Antony J. Blinken, Acting Administrator of USAID Gloria Steele, and Chair of the Board of Gavi José Manuel Barroso, and saw pledges from Sweden, Netherlands, Lichtenstein and Portugal, as well as big donations from the Bill and Melinda Gates Foundation, Gates Philanthropy Partners, and Google. “COVAX represents our best way of ending the pandemic by ensuring equitable global access to safe and effective vaccines,” said Per Olsson Fridh, Sweden’s Minister for International Development Cooperation. “Already reaching over 100 countries, COVAX also shows what we can achieve by working together – from scientists and manufacturers to governments and multilateral organizations, to health workers around the globe. This is an investment not only in global solidarity, but also in our common objective of putting an end to the pandemic. The bulk of the money will go towards Gavi’s Advanced Market Commitment, which UNICEF Executive Director Henrietta Fore called a beacon of hope. “It’s [the AMC] an effective, realistic way to ensure fair and affordable access to vaccines for all,” she said at the high-level event on Thursday. “But getting vaccines off the tarmac and delivered to difficult-to-reach populations requires concerted, coordinated effort and dedicated funding,” said Fore. On another encouraging note, France and New Zealand committed to donating 13 million and 1.6 million surplus doses to COVAX – although Gavi expects “much larger” donations of suprlus doses in the future, added GAVI’s CEO Seth Berkley on Thursday. So far, COVAX has supplied 113 countries with over than 39.5 million vaccine doses, according to UNICEF’s COVID-19 Vaccine Market Dashboard. The global vaccine facility has already enabled access to the following vaccines: AstraZeneca/Oxford (via AstraZeneca and India’s Serum Institute) – up to 1.27 billion doses Pfizer-BionTech – 40 million doses Johnson & Johnson – 500 million doses Novavax – 1.1 billion doses Sanofi/GSK – 200 million doses Read Gavi’s full press release here. Image Credits: Global Fund/Vincent Becker. Growing Consensus Emerging At WTO – Strengthen Supply Chain & Tech Transfer To Expand Vaccine Access 15/04/2021 Svĕt Lustig Vijay WTO Headquarters in Geneva A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. “The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday. “As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” Broader Technology Transfer in Poorer Countries is Possible, Says Iweala Ngozi Okonjo-Iweala, WTO’s newly elected Director-General While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months. “One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said. However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains. Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added. Terrific conference yesterday on solving the problem of inequity in access to vaccines – so no one has to stand in line. Grateful to all the participants; governments, international orgs, vaccine manufacturers, and CSOs! Lots of learning, lot’s of concrete follow up action! https://t.co/YRW1Y1ESf0 — Ngozi Okonjo-Iweala (@NOIweala) April 15, 2021 Discussions On Intellectual Property Waiver Have “Advanced Knowledge” Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS). Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom, United States, Switzerland, and Japan. Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. “Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.” Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules. Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures: Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.” “There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said. “WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.” “And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.” As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. Image Credits: @WTO/Bryan Lehmann. Many Africans May Not Receive Their Second COVID-19 Vaccine Doses Anytime Soon, Africa CDC Warns 15/04/2021 Paul Adepoju Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses. While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus, Dr John Nkengasong, Director of the Africa CDC said while addressing a Thursday morning press briefing. “We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said. At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients. Dr Richard Mihigo “African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon. “I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. Wakeup Call for Africa Prof Oyewale Tomori Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources. “We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. “Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of the rest of the world. We’ve been in this position for too long,” Tomori said. South Africa, DRC to Resume COVID-19 Vaccinations Dr Boitumelo Semete There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing. But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations. “We anticipate the pause will be lifted in a couple of days to come,” Semete said. Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April. “The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said. By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT). Image Credits: Paul Adepoju, Paul Adepoju . WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Growing Consensus Emerging At WTO – Strengthen Supply Chain & Tech Transfer To Expand Vaccine Access 15/04/2021 Svĕt Lustig Vijay WTO Headquarters in Geneva A growing consensus seems to be emerging out of this week’s high-level WTO meeting that glaring inequities in access to vaccines can be remedied by strengthening supply chains, avoiding export bans across borders, and ensuring that big pharma voluntarily transfers its vaccine technologies to poorer countries so they can produce their own vaccines. “The significant inequities we are seeing in access to vaccines between developed and developing countries are completely unacceptable,” said United States Trade Representative Katherine Tai, in a statement published out of her appearance Wednesday at the WTO’s closed-door discussion with high-level representatives from industry, government and civil society on Wednesday. “As governments and leaders of international institutions, the highest standards of courage and sacrifice are demanded of us in times of crisis”, she added. “The same needs to be demanded of industry.” Broader Technology Transfer in Poorer Countries is Possible, Says Iweala Ngozi Okonjo-Iweala, WTO’s newly elected Director-General While Tai’s comments at the WTO forum were deemed “unfair” by the US Chamber of Commerce, the WTO’s new director-general, Ngozi Okonjo-Iweala, seemed to agree that the vaccine industry should more aggressively expand technology transfer in low- and middle-income countries – noting that in one case, technology transfer took only six months. “One of the things that came out [of the discussions at the WTO] is that yes indeed, there is manufacturing capacity that exists now that can be turned around to produce more [vaccine],” she said. However, she did acknowledge that scaling-up vaccine production will also require the training of more skilled personnel, recruitment of raw materials, and stable supply chains. Going forward, “more active” matchmaking between companies with investment capacity and those with untapped production capacity could be fruitful to boost vaccine production in low-income countries, she added. Terrific conference yesterday on solving the problem of inequity in access to vaccines – so no one has to stand in line. Grateful to all the participants; governments, international orgs, vaccine manufacturers, and CSOs! Lots of learning, lot’s of concrete follow up action! https://t.co/YRW1Y1ESf0 — Ngozi Okonjo-Iweala (@NOIweala) April 15, 2021 Discussions On Intellectual Property Waiver Have “Advanced Knowledge” Okonjo-Iweala also said that the closed-door discussions had “advanced knowledge” about the issues surrounding the proposed waiver on WTO rules related to Trade Related Aspects of Intellectual Property (TRIPS). Since it was proposed last year by South Africa and India, the intellectual property waiver has been backed by almost a half of WTO members and discussed eight times at the WTO. However, it seems to have remained in limbo, mostly due to fierce opposition by industry leaders and high-income WTO countries, including key European Union members, the United Kingdom, United States, Switzerland, and Japan. Rather than a wholesale waiver, existing “flexibilities” in the TRIPS agreement could be used to fast-track solutions where needed, said the EU’s Executive Vice-President in a statement after Wednesday’s WTO meeting. “Should voluntary solutions fail, the TRIPS Agreement already provides a framework for sharing technology through the granting of compulsory licences,” said the EU’s Valdis Dombrovskis. “This includes fast-track compulsory licences for export to countries without manufacturing capacity.” Civil Society Call To Revise TRIPS agreement; No Mention Of IP Waiver At the same time, civil society advocates joining the discussions seemed to be steering away from a focus on the IP waiver proposal, instead calling on the WTO to make a series of meaningful technical amendments in the existing TRIPS Agreement – as well as helping low- and middle-income countries to make more effective use of the exceptions contained in the rules. Currently exceptions in the TRIPS agreement are difficult and cumbersome to implement, KEI’s James Love said. He called on WTO members to act on a seven point plan – some related to the easing of existing TRIPS legalities and others outside of its current scope, that he said would ramp up manufacturing capacity. Specifically, he called on WTO and its members for the following measures: Transparency of contracts: Encourage greater transparency of contracts made between by pharma and member states – in line with a recent International Monetary Fund proposal; also, he urged greater transparency from pharma and member states in reporting about drug and vaccine R&D costs, vaccine revenues and the number of doses distributed. Exports of products produced by compulsory licenses: Revise what he called a “flawed” Article 31f and 31bis of the TRIPS agreement, which allows generic producers to export products manufactured under a compulsory license to other low- and middle-income countries only under very restricted conditions; “during a pandemic, there should be no restrictions on the ability to export a useful product under a compulsory license,” added Love. Model Exceptions. The WTO should collaborate with WHO on the development of model patent exceptions for emergencies, Love said, citing Germany and Canada as examples of countries that have already created such legal frameworks – which are often lacking elsewhere. Sharing know-how. Love cited the “failure” of governments that invested heavily in vaccine R&D to include in their funding agreements “measures to require the sharing of manufacturing know-how and access to working cell lines and rights in data.” In the future, the WTO can work with the WHO to develop “initially soft norms” on how such know-how sharing provisions should be included in future R&D funding agreements. WTO Agreement on the Supply of Public Goods. “The pandemic is part of the larger challenge of supporting the global commons. The WTO has been asked to consider a new agreement, based in some ways on the GATS, to create voluntary offers of binding commitments to supply public goods.” Buyouts of know-how. While not the best option last year when governments were funding R&D, today it should be given consideration, he said. Remove sanctions on Cuba, with respect to health related products. “There should be no sanctions on Cuba that relate to the development and distribution of its two promising vaccine candidates.” “There has been an appalling lack of transparency, including regarding the agreements to subsidize and de-risk the research and development of vaccines, as well as procurement contracts and licensing agreements,” Love said. “WTO agreement patent flexibilities have been used in some cases, but many countries have laws poorly equipped to deal with pandemics, vaccines or biologic products, and the provisions in the agreement on exports are flawed.” “And while it is possible to issue a compulsory license on patented inventions, there are few national laws and no global agreements on providing access to manufacturing know-how, working cell lines and rights in test data.” As a further step to support public acquisition of critical know-how, Love has suggested that governments create a buyout fund to allow for “full technology transfer”, including rights to inventions, data, know-how, and biologic resources – similar to the deals reached by private pharma companies such as AstraZeneca when it purchased Oxford’s vaccine technology and/or Pfizer’s acquisition of BioNtech. He has emphasized that governments may not need to buy out the know-how for all vaccines – and suggested that as little as $20 million in funding, with an aim of an initial $1 billion, could help kick off negotiations with manufacturers. Image Credits: @WTO/Bryan Lehmann. Many Africans May Not Receive Their Second COVID-19 Vaccine Doses Anytime Soon, Africa CDC Warns 15/04/2021 Paul Adepoju Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses. While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus, Dr John Nkengasong, Director of the Africa CDC said while addressing a Thursday morning press briefing. “We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said. At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients. Dr Richard Mihigo “African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon. “I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. Wakeup Call for Africa Prof Oyewale Tomori Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources. “We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. “Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of the rest of the world. We’ve been in this position for too long,” Tomori said. South Africa, DRC to Resume COVID-19 Vaccinations Dr Boitumelo Semete There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing. But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations. “We anticipate the pause will be lifted in a couple of days to come,” Semete said. Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April. “The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said. By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT). Image Credits: Paul Adepoju, Paul Adepoju . WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
Many Africans May Not Receive Their Second COVID-19 Vaccine Doses Anytime Soon, Africa CDC Warns 15/04/2021 Paul Adepoju Dr John Nkengasong warns delays in shipments could threaten achieving set vaccination goals in Africa IBADAN – The Africa CDC has expressed concerns over the disruption of the COVID-19 vaccination drive in Africa saying it was preventing many Africans who have received the first dose of the Oxford/AstraZeneca vaccine may not be able to receive the second dose 12 weeks after the first dose as recommended in the vaccination guideline. Rwanda has already exhausted its doses, Ghana is administering its last 100,000 doses even as Nigeria is also racing to administer its remaining doses. While it is not clearly known what the implications of delay in receiving the second dose will be, recipients of the first dose already have some form of immune protection against the virus, Dr John Nkengasong, Director of the Africa CDC said while addressing a Thursday morning press briefing. “We don’t know that delay by a couple of months or weeks, will impair the ability to boost it (immune system) when you get a second dose. I don’t think so. It’s just that it doesn’t give you that full range of your immune system reacting and getting ready to fight the virus once you get exposed to it. But they can be assured that with the first dose, they are already getting some protection from developing disease,” Nkengasong said. At a WHO African region press briefing, Dr Richard Mihigo, Immunization and Vaccine Development Programme Coordinator at the WHO Regional Office for Africa, noted that African countries did the right thing by using the first shipments they received to immunise as many people as possible instead of halving the recipients in order to fully immunise some recipients. Dr Richard Mihigo “African countries, I must say, took the right decision with the limited supply to use most of their doses as the first dose with the expectation that the second dose will come quite soon,” he added. While admitting that there have been some challenges regarding the arrival of the second doses, the WHO said indications from COVAX Secretariat and other ongoing discussions pertaining to the AstraZeneca vaccine for which many African countries have applied a 12-week interval between dose one and dose two, suggest the additional shipments will be available soon. “I think everything is being put in place to make sure that they can receive the second shipment on time to deliver the second dose of the AstraZeneca vaccine,” he added. Wakeup Call for Africa Prof Oyewale Tomori Oyewale Tomori, Professor of Virology at Nigeria’s Redeemer’s University, noted that the circumstances surrounding delays in receiving shipments for second doses of the vaccine is a wakeup call for Africa as a continent to be more proactive regarding its vaccine sources. “We’ve been at the receiving end of global omission for too long. Now is an opportunity for us to plan for the future. We shouldn’t be in this position again,” he said. He enjoined African leaders to be more proactive, move the continent forward and stop its dependence on the rest of the world. “Our leaders must be proactive in getting this. We shouldn’t repeat this issue when we are at the mercy of the rest of the world. We’ve been in this position for too long,” Tomori said. South Africa, DRC to Resume COVID-19 Vaccinations Dr Boitumelo Semete There are meanwhile indications that COVID-19 immunizations with the Johnson & Johnson vaccine will soon resume in South Africa and begin in the Democratic Republic of Congo with the AstraZeneca vaccine – despite the concerns registered in the USA and Europe over rare occurrences of blood clots from those jabs. On 13 April, the Minister of Health of South Africa, the only African country that is rolling out the Johnson & Johnson COVID-19 vaccine, announced that the country has decided to pause rollout of the vaccine as a precautionary measure as review of the situation is ongoing. But while addressing the WHO press briefing, Dr Boitumelo Semete, CEO of the South African Health Products Regulatory Authority, announced the country will soon resume J&J vaccinations. “We anticipate the pause will be lifted in a couple of days to come,” Semete said. Semete noted that the decision to pause the vaccine rollout was to enable the country to review available data considering only a few countries have rolled the vaccine. For DR Congo, Africa CDC announced the country is ready to nationally roll out the Oxford/AstraZeneca COVID-19 vaccine from 19 April. “The Democratic Republic of Congo’s Minister of Interior announced yesterday that the country will finally launch the national COVID-19 vaccination campaign on 19 April, initially suspended due to concerns about adverse events related to the AstraZeneca vaccine,” Nkengasong said. By 12 April 2021, over 34.6 million vaccine doses have been acquired by African countries with nearly 14 million doses administered so far. Morocco, Nigeria and Ghana are leading with 8.6 million, over 1 million and nearly 700,000 doses administered respectively. Moreover, 32 African countries have received consignment of COVID-19 vaccines from the COVAX facility, with 12 additional countries receiving allocation through the African Vaccine Acquisition Task Team (AVATT). Image Credits: Paul Adepoju, Paul Adepoju . WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
WHO Europe Urges Denmark To Share Surplus AstraZeneca After Country Stops Using The Vaccine 15/04/2021 Chandre Prince Denmark will no longer use the AstraZeneca COVID-19 vaccine, making it the first European country to abandon the jab over suspected rare but serious side effects. The World Health Organization (WHO) Europe region sidestepped criticism of Denmark’s decision to permanently stop administering the AstraZeneca vaccine, saying the country’s low population numbers and low COVID-19 positivity rate of under 1% allowed for a lot of room to manoeuvre. Denmark’s low rate of infections gives the country manoeuvring room in terms of their vaccine choices, WHO European regional COVID-19 incident manager Dr Catherine Smallwood said during a press briefing on Thursday. “Denmark has had an ability to bring down cases to really controlled levels, has widespread testing, and has a testing positivity rate of significantly under 1%, which means that they are quite confident in their current ability to control COVID-19 in the country. So I think that’s something that really has to be made very specifically in the context of any discussions around Denmark and its decisions around vaccination,” said Smallwood, adding that the country had managed to bring down COVID-19 levels since the beginning of the year. At the same time Smallwood and WHO Regional Director Hans Kluge reaffirmed WHO’s confidence in the overall safety of the AstraZeneca vaccine, saying there is far more risk of blood clots from COVID-19 infections, than from the vaccine. But in light of the decision, Kluge urged the Danish government to share its surplus AstraZeneca vaccines with other countries in need. Denmark Is First Country To Permanently Halt AstraZeneca Use Denmark on Wednesday became the first country to permanently stop administering the AstraZeneca vaccine, a month after suspending its use following reports that a small number of recipients had developed a rare but serious blood-clotting disorder. Announcing the decision, Danish health director general Dr Soeren Brostroem, said Denmark was able to halt use of the vaccine because it had the pandemic under control and could rely on two other vaccines, from Pfizer and Moderna. Their decision, said Brostroem, was “based on the scientific findings, our overall assessment is there is a real risk of severe side effects associated with using the Covid-19 vaccine from AstraZeneca”. “If Denmark were in a completely different situation and in the midst of a violent third outbreak, for example, and a health care system under pressure,” he added, “then I would not hesitate to use the vaccine, even if there were rare but severe complications associated with using it.” A man receives his Covid-19 vaccine in Jutland, Denmark. The country initially suspended the use of the vaccine on March 11, along with Iceland and Norway. Several other European countries, including France, Germany and Italy, followed suit last month. Siddharta Datta, WHO-Europe vaccination expert, said they were keen to learn from Denmark’s monitoring and reporting systems of safety events that led to this decision. “Countries, not only Denmark, or any of all our 53 Member States would have a system in place so that they can monitor any of the safety events, and then make a decision. The countries are suffering to look into their own data and then make a decision. We are keen to learn from Denmark into this whole process on the investigated results, and thereafter,” said Datta. With a population of 5.8 million, Denmark has managed to contain the pandemic. As of Wednesday, Denmark had recorded 2,447 Covid-related deaths. Almost one million people in the country have received at least a first dose of a vaccine, 77% of them received the Pfizer vaccine according to Denmark’s Serum Institute. Around 15 % received a first dose of the AstraZeneca vaccine before the authorities suspended its use last month, and the remaining 8 % received the Moderna vaccine. Denmark Urged to Share Leftover AstraZeneca Vaccines WHO Regional Director Hans Kluge Asked to comment on what European countries, including Denmark, should do with the excess vaccines that are not being used, Kluge said he had discussed the issue of donating or reselling Denmark’s excess vaccines with Dr. Susan Brewster, the Director General of the Danish Board of Health. Kluge said he is of the understanding that Denmark was “already looking into options of sharing”. Kluge however stressed that “safety is paramount” for WHO, and said among the 200 million people who had been vaccinated with AstraZeneca, only a “very small number” of blood clotting had been reported. He urged member states to report any adverse events that may occur following vaccination, as early as possible. “For now, the risk of suffering, blood clots, is much higher for someone with COVID-19 than for someone who has taken the AstraZeneca vaccine. There’ll be no doubt about this. AstraZeneca vaccine is effective in reducing COVID-19 hospitalisation. WHO recommends it to all eligible adults to gain protection from COVID-19 quickly as possible.” WHO was also monitoring reports of thrombo-embolic events in a small number of people who were administered with the Johnson and Johnson vaccine and will in due course communicate motoring reports on it. Last week, the WHO Europe region surpassed 1 million confirmed COVID-19 deaths. “The situation in our region is serious, 1.6 million new cases are reported every week. That’s 9500 every hour, 160 people, every minute,’ said Kluge, adding that COVID-19 preventive measures need to remain in place while vaccination campaigns proceed. To date, 171 million doses of seven COVID-19 vaccines and products have been administered in WHO’s European region, which also includes Turkey, Israel and republics of the former Soviet Union. Some 13% of the European population have received at least one vaccine dose, while close to 6% have completed a two-dose vaccine series. Among European Union countries, WHO singled out Greece for already vaccinating 1.6 million people – or 16% of the population – with at least one dose, while 7% are fully covered. Green Passports Could Lead to Prioritisation of Vaccines for Travellers Kluge also reiterated WHO position opposing Europe’s creation of “green passports” for travel – repeating statements made just after the European Commission outlined proposals for the EU’s “digital green pass” – which would allow travellers who have been vaccinated, or recovered from COVID-19, to move freely without being subject to quarantine. Kluge said that WHO is concerned such a rule could lead to the prioritisation of vaccines for international travellers, rather than health workers, older people or other priority groups. “We do not encourage at this stage that getting a vaccination determines whether you can travel internationally or not,” said Kluge at the time. Kluge however said it “extremely important that we have documentation of the people who are vaccinated…or the vaccination effectiveness”, but that it should not be called a passport. WHO was currently examining the political, ethical and legal aspects of the digital green card to minimise inequalities, said Kluge. Greece has already signed a bilateral agreement with Israel to allow vaccinated or recovered travellers to move freely between the two countries. The country’s tourism sector re-opens mid-May. Greek Minister for Health, Dr Vassilis Kikilias, Minister of Health of Greece, also attended the press briefing, to announce the creation of a new WHO quality of care centre in Athens. He said the centre will serve the needs of countries of the south eastern part of the region, and the Mediterranean basin, focusing on technical assistance, support and leadership on quality of care and patient safety. New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
New Partnership To Boost Africa’s Vaccine Research, Development And Manufacturing 15/04/2021 Paul Adepoju A new partnership between Coalition for Epidemic Preparedness Innovations(CEPI), Africa CDC and the African Union Commission to enhance vaccine research, development and manufacturing in Africa has been hailed as “critical” to enable countries to take ownership of their national health security. Following a two day African Vaccine Manufacturing Virtual Conference held earlier this week, the CEPI and AUC announced an agreement that will ultimately see the strengthening of the COVID-19 pandemic and outbreak preparedness on the continent, build on key lessons from the COVID-19 pandemic and leverage the successes recorded by the procurement and distribution of vaccines through COVAX and African Vaccine Acquisition Task Team (AVATT). The agreement was one of the major highlights of the conference that featured deliberations on various key aspects of vaccine manufacturing in Africa. It was concretised with a memorandum of understanding that was signed by all three institutions. The partners said they would also invest in vaccine R&D innovations to enable faster and easier production of vaccines in Africa; invest in capacity building and training to foster the development of local expertise needed to boost vaccine R&D and manufacturing in Africa; strengthen institutions that enhance enabling science needed for vaccine development – for example, through investments in regional laboratory and research hubs across Africa – and build partnerships that enable the sustainable expansion of vaccine manufacturing in Africa. Dr John Nkengasong, Director of the Africa CDC, said the partnership was critical for Africa to achieve its lofty local vaccine manufacturing goals. “Trusted partnership will be critical in advancing the vaccine manufacturing agenda on the continent. The partnership with CEPI symbolises cooperation and collaboration to help respond to infectious disease threats and ensure Africa’s health security,” Nkengasong said. Importantly, the initiative will help strengthen Africa’s capacity to prevent, detect, and respond to emerging and re-emerging infectious threats, according to Richard Hatchett, CEO of CEPI. “By building regional resilience and strengthening health security on the continent, we can mitigate the disproportionate health and economic impacts that epidemic infectious diseases can have on populations in low and middle-income countries,” Hatchett said. Health Policy Watch on Monday reported a number of speakers including Abderrahmane Maaroufi, Director of Morocco’s National Public Health Institute, recommending that Africa prioritise the development of vaccines for emerging diseases including Ebola, Lassa fever and Rift Valley Fever (RVF). This approach is in line with CEPI’s vaccine pipelines as it has candidate vaccines for these three diseases. Early this year, a CEPI-funded vaccine programme kicked off the first clinical trial of a Lassa fever vaccine candidate to be conducted in West Africa, where the virus is endemic. CEPI also has two RVF vaccine candidates in its portfolio. Trusted Partnerships are Critical in Building Africa’s Vaccine Manufacturing Agenda Throughout the conference, African leaders and experts provided indications that lessons learnt from Africans countries having to look on as the developed countries immunise their citizens, should spur actions that will ensure that the continent is better prepared for the next pandemics. South Africa’s President Cyril Ramaphosa said that despite Africa’s delayed access to COVID-19 vaccines, the continent has shown that its capabilities cannot be overlooked, even as its leaders are demonstrating greater political commitments towards prioritising people’s wellbeing on the continent. “Throughout this pandemic, Africa has demonstrated it has substantial and extensive capabilities as well as resources and skills to address the challenges that have given rise to the pandemic. Africa’s response has shown the depth of scientific expertise on the continent and has provided opportunities for unprecedented scientific collaborations,” Ramaphosa said. South African President Cyril Ramaphosa Ramaphosa said Africa, in the medium term, needed to expand available capabilities into regional hubs that serve the entire continent. “We also need to forge sustainable partnerships with entities in both developed and developed worlds. Partners in various countries could offer technological expertise, financing and investments. Countries such as India and Brazil could provide guidance on how they developed their own generic pharmaceutical industries,” President Ramaphosa added. The pandemic has however shown that vaccine equity cannot be guaranteed by goodwill alone, said Rwanda’s President Paul Kagame, further urging the continent to expand production capacity for vaccines and other essential medical products. “Vaccine production goes hand-in-hand with increased investment in health systems as well as building an efficient and autonomous African CDC. Rwanda is ready to play a role in the effort together with other member states and partners,” he said. President Paul Kagame of Rwanda For Felix Tshiseked, President of the Democratic Republic of Congo, the emphasis was on the need for Africa to achieve vaccine, diagnostic and therapeutic security. In his closing remarks, Nkengasong urged African governments and its partners to” act now, act collectively but act differently”. “Trusted partnerships will be critical in building Africa’s vaccine manufacturing agenda,” he said, adding that it would take greater collaboration for Africa to overcome its challenge of currently only meeting only 1% of its vaccine needs to 60% by 2040. “We are fully aware that this will be a challenge but we are also aware that a journey of 1,000 miles begins with a single step,” he said. He warned that if Africa does not plan to address its vaccine security needs today, the continent is setting itself up for failure. He then announced a partnership with Afreximbank and the Africa Finance Corporation to support the development of vaccine manufacturing in Africa by focusing on four areas of support — identifying and engaging partners, co-financing transactions and projects, providing preparatory support to project developers and promoters, and providing policy and advocacy support to unlock major market barriers. ‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy Loading Comments... You must be logged in to post a comment.
‘Unexamined Prejudices’: COVID-19 And Patents 15/04/2021 Sir Robin Jacob This past few weeks has seen a flurry of open letters from academics, politicians and NGOs dispatched to British Prime Minister Boris Johnson, US President Joe Biden and other heads of state, urging their governments to support a proposal to the World Trade Organization to for a proposed “waiver” suspending intellectual property (IP) rights, and the enforcement of patents, on COVID-19 health products during the pandemic. The conflict about patents and medicines is long-standing. But in the light of reports that Washington may indeed support the temporary waiver of IP, it is time to call out why the proposal is at best useless, and at worst, would seriously undermine the kinds of medical innovation so long supported by the US. Pro IP Waiver is Strong on Beliefs, Thin on Facts Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, criticizes patents for vaccines and medicines The critics, who include Professor Mariana Mazzucato (UCL Institute for Innovation & Public Purpose), chair of the new World Health Organisation (WHO) Council on the Economics of Health for All, believe that patents for medicines and vaccines are fundamentally a bad thing. Amongst other bad things, patents are blamed for keeping prices high; restricting access to medicines (particularly in the developing world); and making big pharma companies very profitable. Critics further claim that medicines are often based on inventions made by public bodies (such as universities or research institutes) but then hijacked by big pharma; which drives the direction of research to profit, not public good. The critics say the best remedy for these ills would be to dismantle the patent system for medicines and vaccines altogether. Or, if not that, then such patents should be the subject to compulsory licences, which countries could issue easily and at will to produce generic or biosimilar versions of patented innovations. To take control of innovation, critics believe the direction of research should be dictated by a state-appointed body. It should not be aimed at finding new medicines that generate profit; instead it should be “mission oriented.” Moreover universities and research institutes should either dedicate their medical inventions to the public or at least licence all-comers. IP Supports an Innovation System That Puts the Risk of Failure with Innovators Those defending patents argue that it is has been the basis of pharmological innovation for over a century The defenders of patents for medicines and vaccines contend that the prospect of obtaining a patent, and indeed making a profit, has been the major foundation upon which successful pharmaceutical innovation has been based for over a century. Those defending patents do not start with theories, beliefs, or assumptions but with facts. Fact: It takes a long time, normally 12-15 years ,from patent filing to take a putative new medicine to market – because that is how long it commonly takes to prove that it is effective and safe. Vaccines can be done more quickly. But until the vast pressures exerted by the COVID pandemic, aided by big government investments, the typical R&D period was still on the order of 8 years. Fact: The patent will expire at the end of twenty years from filing, with the possibility of a few more years (maximum 5) of extra protection. The cost of getting a wholly new drug to market is on the order of $US 1.5 billion. If you have to build a new production line, which you would for any new vaccines, it would typically take you up to 5 years, and $US 500 million of investment. Most putative medicines fail to reach the market at all – sometimes after the failure of Phase III trials and expenditures on the wrong side of $US 1 billion. The odds are low for vaccines too. Experience is no guarantee of success. In January, for instance, one of the world’s leading vaccine makers, MSD, threw in the towel for its two COVID-19 vaccine candidates. The business model of big pharma depends on finding new successful medicines. The CEO of a big pharma company knows that all of the company’s products will lose protection within around 10 years or less , and many much sooner. In rough figures, worldwide the big innovative pharma companies still spend four times more than the combined spend of governments and charities on R&D. Academics, Generic Producers, All Need Strong IP to Thrive Most of the medicines on the WHO Essential Medicines List are no longer patented Fact; Most important medicines are no longer protected by patents. Around 95% of the products on the WHO List of Essential Medicines, are no longer patented. Without the innovation in the first place, we would not have had many of the now generic medicines on that list. The cost of patented medicines is but a minor aspect of costs to health systems as a whole. Fact: Neither universities nor research institutes have the resources or expertise to bring their basic research for a potential medicine to market. What works is cooperation between an research institute that found a product with potential and a big pharma company. A good recent example is the cooperation between the Japanese research institute Ono and Bristol-Myers-Squibb to bring Professor Tasuku Honjo’s Nobel prize winning invention of cancer curing anti-PD antibodies to market. But it is obvious big pharma will not (and cannot afford to) take on a nascent medicine that, if (and when) proven to be successful, can immediately be copied. It is naive to believe that Governments could or would do it – no new medicine has been brought to market by a government. Final fact: there is no evidence that compulsory licensing has provided significant access to medicines or vaccines. It has in some cases reduced prices a little (not a large) amount and it has made some people who took no risk and contributed nothing by way of pharma research very rich. Defenders Do Not Say That the System is Perfect Neglected Tropical Diseases go largely unnoticed, as there is little incentive to investigate new medicines with no chance of profits The IP system has its limitations. For instance there is little incentive to investigate new medicines for neglected diseases, where there are no prospects of profits. But even here, the private sector is the second largest funder after the USA’s National Institutes of Health (NIH). COVID-19 has intensified the arguments between critics and defenders of the current IP system. Much of the debate has been largely irrational, both about medicines and vaccines. It is largely a trumped-up cause. There cannot be any existing patents for medicines or vaccines specifically directed at COVID 19: because the patenting process takes a long time – a few years even in the fastest Patent Offices. There are or may be patents for some re-purposed known medicines (though most will probably be out of patent) and maybe some on more general vaccine production. But no-one has identified any specific patent relevant to vaccines which is being used to stop production – nor identified any patented re-purposed medicine in short supply. Waiving IP Won’t Help Scale Up Manufacturing of COVID-19 Vaccines The real challenge is manufacturing the vaccines, not the patents for them Anyway, patents for vaccines are rare. The challenge is manufacturing. Vaccines are not like small molecule medicines where a single factory can readily make enough active ingredient for a country or even a continent. Vaccines require elaborate, dedicated facilities and a huge amount of know-how. Even then, things can and do go wrong because the processes are biological – witness the recent production problems seen in Pfizer and AstraZeneca facilities in the United States as well as in Europe. And, as far as I know, no-one has ever applied for a compulsory licence under a patent relating to a vaccine. Even if a company got a licence, where would it get the investment to build a factory and the skills to run it? The bottleneck for vaccines is not patents or IP but simply investment in production capacity. Patent System, Even in Extraordinary Circumstances, Stands the Test of Time Fortunately, there are now a number of COVID-19 vaccines that have received emergency use authorizations from the US Food and Drug Administration, the United Kingdom’s Medicines and Healthcare products Regulatory Agency and the European Medicines Agency, among other regulatory authorities. We have to thank big pharma for this. If those companies had been diminished, as the critics have long wanted, where would we be now? Does anyone realistically expect governments to pay for risky long-term research? The truth is that the patented medicines of today pay for the medicines of tomorrow. It is time for the critics to understand the patent system: that it really does advance innovation and lead to new medicines. The English philosopher, jurist, and social reformer, the founder of modern utilitarianism, Jeremy Bentham, said it all back in 1792: “So long as men are governed by unexamined prejudices and led away by sounds, it is natural for them to regard Patents as unfavourable to the encrease of wealth. So soon as they obtain clear ideas to annex to these sounds, it is impossible for them to do otherwise than recognize them to be favourable to that encrease: and that in so essential a degree, that the security given to property can not be said to be compleat without it.” The critics should put aside their “unexamined prejudices” and cease to be “led away by sounds”. ___________________ Professor Sir Robin Jacob, University College London The Rt. Hon. Professor Sir Robin Jacob, holds the Hugh Laddie Chair as Professor of Intellectual Property Law, University College London, for the past 10 years. He practised at the Intellectual Property Bar since 1967, was made a Queen’s Counsel in 1981 and served as a High Court Judge (Chancery Division) from 1993 to 2003. He was appointed a Lord Justice of Appeal in October 2003 where he was in charge of the Court of Appeal’s Intellectual Property List. He has written extensively on all forms of intellectual property, including “IP and Other Things”, published by Bloomsbury. Image Credits: Open Source/Flickr, Marco Verch/Flickr, MissionInnovation/Flickr, Marco Verch/Flickr, Marco Verch/Flickr, Naiad Productions. UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts This site uses cookies to help give you the best experience on our website. Cookies enable us to collect information that helps us personalise your experience and improve the functionality and performance of our site. By continuing to read our website, we assume you agree to this, otherwise you can adjust your browser settings. Please read our cookie and Privacy Policy. Our Cookies and Privacy Policy
UK COVID-19 Variant Not Linked to Severe Disease or Reinfection – New Lancet Study 14/04/2021 Editorial team The variant of SARS-CoV-2 2, B.1.1.7 is now the most common COVID-19 strain in the United States and has been reported in 125 countries, according to the WHO Weekly Epidemiological Update. Two studies published by The Lancet Infectious Disease and The Lancet Public Health report that the United Kingdom’s dominant strain of the virus is not linked to more severe disease or death, and that there was no apparent increase in reinfection rate from the variant. The variant of SARS-CoV-2 2, B.1.1.7, emerged as the dominant cause of COVID-19 infection in the UK in November 2020, with its high transmissibility when compared to other strains. B.1.1.7 has since been reported in 125 countries, according to the WHO Weekly Epidemiological Update. The variant is now the most common COVID-19 strain in the United States. In the study published in The Lancet Public Health, researchers used data collected from 36,000 participants of the COVID Symptom Study App, and investigated whether the appearance of the B.1.1.7 variant was connected with differences in symptoms, duration of disease, hospital admission, asymptomatic infection, risk of reinfection, and transmissibility for users reporting a positive test result from 28 September and 27 December 2020. The data was used in combination with surveillance data from the COVID-19 Genomics UK Consortium, which randly sequences viruses from positive test samples in the UK, to determine what proportion of positive tests included the B.1.1.7 variant. Overall, researchers found no association between the B.1.1.7 variant and type of symptoms, disease duration, asymptomatic infection, and hospital admission, and a low prevalence of possible reinfection. This data suggests that vaccines developed against previous variants will be effective against B.1.1.7, said Mark Graham, research associate at King’s College London and lead author of the study. Graham also adds that the data “suggests that B.1.1.7 doesn’t really have a substantial effect on reinfection, and immunity developed from previous infections with COVID should sufficiently protect against B.1.1.7. “ Researchers from the study published in The Lancet Infectious Diseases further investigated reports of increased transmissibility by sequencing the virus obtained from samples in 341 patients who had tested positive for COVID-19 in two London, UK hospitals between November and December 2020. 58% of the 341 patients had the B.1.1.7 infection and 42% had non-B.1.1.7 infection. Researchers found no association between the variant and disease severity. Those infected with B.1.1.7 were also no more likely to die compared to those infected with another SARS-CoV-2 strain. “We didn’t find an association between severity of disease with the variant after adjusting for other factors [like age, ethnicity and other health conditions],” said Dr Eleni Nastouli, associate professor of infection, immunity, and inflammation at the University College of London and study lead. Posts navigation Older postsNewer posts