Rwanda
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.

chagas
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.

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.

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.

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:

  1. 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.
  2. 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. 
  3. 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. 
  4. 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.
  5. 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.” 
  6. 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.
  7. 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.

africa cdc
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 .

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
patent
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.

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.

Patents are not the main roadblock to producing enough coronavirus vaccines for the world – rather the challenge is technology transfer with manufacturers, said a top official at the Bill and Melinda Gates Foundation (BMGF) on Wednesday. 

His comments joined those of pharma voices in what seems to be a growing counter-trend to that of civil society advocates who say that intellectual property (IP) monopolies are blocking the rapid scale-up of manufacturing. 

Speaking at an event sponsored by the Geneva Graduate Institute’s Global Health Center, Chris Elias also said that the Foundation is presently working on a number of new tech transfer agreements to expand vaccine manufacturing in low- and middle-income countries – which have not yet been made public. 

“I don’t want to say patents are never the problem, but I think the bigger problem in vaccines is how do we get as many of these tech transfers so that we can get high quality, low cost vaccine at scale as soon as possible,” said Elias, President of the Foundation’s Global Development Division. 

“As we’ve been working with the vaccine companies, now, the challenge seems to be more about the tech transfer, the rapid scale-up, the capacity for producing vaccines,” he said at the webinar on “Public and private responsibilities in COVID-19”. 

“We are actually supporting a range of different tech transfer efforts,” said Elias. “We are working on other tech transfer agreements that are just not ready to be announced yet.”

The Foundation played an important role in mediating the successful licensing deal for the AstraZeneca vaccine with one of the world’s vaccine manufacturing powerhouses – India’s Serum Institute – which has enabled hundreds of millions of doses of the AstraZeneca vaccine to be produced for the world. 

“We were able [with] Gavi to move quickly with Serum Institute of India because it is such a large scale and well established partner of COVAX, but it’s not exclusive in any regard,” Elias noted. 

Gates Was Not Part Of Oxford-AstraZeneca Decision To Exclusively License Vaccine Technology

Chris Elias, President of the Foundation’s Global Development Division.

But Elias denied that Gates had played a role in Oxford University’s decision to exclusively license its vaccine technology to AstraZeneca, instead of sharing the vaccine recipe openly – a  decision that has come under intense fire from vaccine access advocates.

“We were not part of the individual licensing agreements, I’d have to defer to Oxford. We weren’t a part of those negotiations between them and AstraZeneca,” he said.

Rather, he said that the Gates Foundation tried to help Oxford University “align” with pharma  companies that could ensure its technology could be brought to scale.  

“No university is positioned to start making billions of doses of vaccine,” said Elias. “In my experience of 20 plus years, every case where a university has found a new innovation they have to have a partnership with pharma to get to scale.”

“There were a number of organizations including the Gates Foundation that had discussions with Oxford. And they discussed the importance of aligning with a multinational company in order to ensure that they could bring their innovation to scale and benefit humanity.”

Waiving Intellectual Property Is Not Way Forward, Says Elias

With regards to the proposed World Trade Organization waiver of IP rules under the WTO’s  Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, Elias expressed skepticism, noting that the Foundation “hasn’t been very involved” in those discussions.   

“It could be debated whether waiving TRIPS is going to get you there faster so I think we really want to focus on what can we do now to secure as much supply for the the advanced market commitment and COVAX for vaccines,” he said, referring to the WHO co-sponsored global vaccine facility. “I’m not aware that we’ve used our voice to try and influence people’s position on that [the WTO waiver].”

And although he acknowledged that mechanisms like the WHO’s proposed COVID-19 Technology Access Pool (C-TAP), to share intellectual property for COVID-19 health technologies, may be “useful” at some point, he argued that it is not needed at this moment. 

“It’s not correct to say that we’re not in favor of it [CTAP],” he said. “I think it’s a useful mechanism…If a patent proved to be the obstacle, C-TAP or some other mechanism could be part of the solution….In our experience, patents haven’t been so much the problem,” Elias  said. 

“The real issue is to “build more manufacturing capacity”, he said, “that’s a different kind of problem that’s not going to be solved by C-TAP, so we’re not opposed to C-TAP [but] it’s just not in our experience the solution we need at this moment.”

Beyond IP and even vaccine technology know-how, there are many other bottlenecks to expanding manufacturing capacity, like high-quality medical glass, which is currently in shortage, Elias stressed. 

WHO DG Asserts That IP Waiver Is Relevant  

Meanwhile, in a parallel forum underway Wednesday at the WTO, the WHO Director General Dr. Tedros Adhanom Ghebreyesus outlined a countervailing view that a proposed WTO waiver of COVID-related IP could expedite the sharing of know-how and technologies – stating that the WHO’s C-TAP IP pool may be immediately relevant.

The closed door WTO meeting brought together leading pharma manufacturers, banking officials and health ministers to discuss WTO Director General Ngozi Okonjo-Iweala’s proposed “Third Way” to expand access through more voluntary licensing to manufacturing companies in LMICs. 

“This is an unprecedented emergency that demands unprecedented measures,” Tedros said at the high-level forum, including representatives from Pfizer, Moderna and AstraZeneca, as well as the International Federation of Pharmaceutical Manufacturers (IFPMA) and the Developing Countries Vaccine Manufacturers Network.

“We must leave no stone unturned. We must explore every option for increasing production, including voluntary licenses, technology pools, the use of TRIPS flexibilities and the waiver of certain intellectual property provisions,” he said. 

Tedros also defended the COVID-19 Technology Access Pool (C-TAP), which has failed to generate interest from big pharma, even though it has been backed by 40 countries so far. 

“Like COVAX, it [C-TAP] holds enormous potential, but like COVAX, that potential has not been fulfilled,” he said. “WHO is also calling for expressions of interest to establish technology transfer hubs to assist countries acquire vaccine technology and know-how as rapidly as possible.”

“The current company-controlled production sharing agreements are not coming close to meeting the overwhelming public health and socio-economic needs for effective, affordable and equitable access to vaccines, as well as therapeutics and other critical health technologies.“

IFPMA Comments At WTO

Thomas Cueni, director general of the IFPMA

In an IFPMA statement at the WTO event, Director-General Thomas Cueni offered a pharma counterpoint that echoed the Gates official, saying: 

“We tend to forget the daunting task of scaling up manufacturing. Vaccine manufacturing is a complex biological process. Vaccine development is not granted for success. We have seen problems with scarcity of raw materials ingredients, and we have problems with export restrictions. 

“We are on track with this target of 10 billion doses, because industry is doing what society and all of you would have expected it to be doing, namely: engaged in unprecedented partnerships, in unprecedented technology transfers. I’ve counted 272 partnerships, which the industry has signed on COVID-19. More than 200 of them involving technology transfer.  I expect that we will see more also in terms of partnership, building capacity.  

“We are willing to sit down with our partners in COVAX to see what can be done in terms of supply chain visibility, in export restrictions to accelerate trade – WTO will play an important role there. We truly know that no one is safe until everyone is safe.”

Civil Society Calls on United States To Play A Bigger Leadership Role 

Meanwhile in Washington DC, some 66 health and development organisations called on US President Joe Biden to launch a global vaccine manufacturing program to end the pandemic.

The open letter, published by Public Citizen on Tuesday, called upon the United States to invest US$ 25 billion to establish in collaboration with the WHO hubs for vaccine production in Africa, Asia and Latin America; and to ensure open sharing of technology via WHO’s C-TAP access pool. 

The group called on President Biden to “announce and implement a global vaccine manufacturing program to end the pandemic and build a globally-distributed vaccine infrastructure for future pandemics.

“Much more ambitious U.S. leadership is needed to end the global pandemic,” said Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “The U.S. government should establish, urgently, a manufacturing operation for the world, that would share vaccine recipes and work with the World Health Organization to alleviate suffering and bring billions of additional vaccine doses to humanity.”

Image Credits: IFPMA .

COVID-19 cases in India have skyrocketed by 70% in the past week

India has greenlighted Russia’s Sputnik V vaccine for emergency use following a severe shortage of vaccines against the coronavirus and a massive spike in cases, and is now poised to become one of the world’s largest manufacturing hubs for the vaccine with 50 million doses produced by July. 

India’s aproval of a third COVID vaccine comes as the country recorded over 185,000 new cases of COVID-19 on Tuesday – which is almost double that at the height of the first wave seen last September – and represents a 70% increase in cases over just the past week. 

So far, India has administered 100 million vaccine doses to its population of 1.4 billion people. These include Covishield, the lstraZeneca-Oxford vaccine being manufactured locally by the Serum Institute, as well as the indigenous Covaxin, developed by India’s Council for Medical Research, and manufactured by Hyderabad-based Bharat Biotech.

Sputnik V, produced by Moscow’s Gamaleya Institute and marketed abroad by the Russian Direct Investment Fund (RDIF), is a two-dose adenovirus vaccine that has boasted an efficacy of 91.6% in clinical trials  – nearly on par with the highest-performing mRNA vaccines produced by Moderna and Pfizer/BioNTech. It is priced at only $10 per dose, which is only a third of the cost of its mRNA counterparts, and rather requiring ultra-deep freeze, can be stored in conventional refrigerators for months.

Sputnik V costs $10 per dose and can be stored in conventional refrigerators, making it ideal for low-income settings

India Plans To Produce 50 Million Doses of Sputnik By July

Through new partnerships and “working capital” investments with five vaccine manufacturers, India should have the capacity to produce over 50 million doses of Sputnik by July, announced the CEO of the RDIF on Tuesday.

“We have announced partnerships with five of the largest production companies in India,” said Kirill Dmitriev, noting that improved manufacturing capacity will help speed up India’s vaccination drive. “We will be announcing a few more.”

The new partnerships, sealed with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, and Virchow Biotech, will help India become the world’s “largest production hub” of Sputnik, said Dmitriev, who called it a “Russian-Indian” vaccine.

“We believe Russia and India will be the largest production hubs [of Sputnik V] in the world,” said Dmitriev. “We actually think of this [Sputnik-V] as Russian-Indian vaccine because lots of production will be done in India,” said Dmitriev at a virtual press conference.

In recent months, the RDIF has partnered with a dozen countries to manufacture Sputnik, including China, Kazakhstan and South Korea. In total, it aims to produce 850 million doses of the vaccine a year.

Meanwhile, as India begins to ramp up domestic production of Sputnik V, the country may see its first deliveries of the vaccine from other RDIF production centers abroad within the next three weeks, Dmitriev told India Today. 

Dmitriev also said that RDIF is in negotiations with the Indian government to set a differential price for Sputnik V for the private and public health sectors.

India Will Fast-Track Approval of Foreign Vaccines 

In another effort to expedite the country’s massive vaccination drive, the Indian government also announced that it will fast-track foreign vaccines that have been approved by “credible” regulatory authorities – such as the US Food and Drug Administration, the European Medicines Agency, or the WHO’s Emergency Use Listing.

India’s health secretary Rajesh Bhushan said this will speed up India’s vaccination drive by overcoming the need for local clinical trials, the so-called “bridging trials”, which serve to ensure that foreign vaccines cater to the Indian context. 

“The pre-condition of having bridging clinical trials for a foreign vaccine before emergency use authorisation has been done away with and has been replaced with a parallel bridging trial post-approval,” he said in a press release.

“This decision will facilitate quicker access to such foreign vaccines by India & would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic use,” said the press release.

Image Credits: RDIF, WHO.

Transparency in medicine pricing is a key theme of the Fair Pricing Forum that started this week.

The World Health Organization (WHO) and the World Trade Organization (WTO) both are hosting key global meetings aimed at improving global access to COVID-19 vaccines and fair medicine prices this week behind closed doors.

The WHO Fair Pricing Forum started on Tuesday and its stated aim is to activate “additional support for countries to achieve more affordable and fairer access to pharmaceutical products during the COVID-19 pandemic and beyond”.

Meanwhile, on Wednesday, the WTO Director General, Ngozi Okonjo-Iweala, will host a meeting on “COVID-19 and Vaccine Equity: What can the WTO Contribute”.

The Fair Pricing Forum (FPF), supported by the Ministry of Health of Argentina and running virtually until 22 April, is likely to focus on transparency of medicine prices and production as well “upstream innovation” aimed at widening the manufacturers’ pool. 

This is according to Suerie Moon, co-director of the Global Health Center of the Graduate Institute of Geneva and a member of the FPF expert advisory group, who describes the forum as an “important space for governments to connect and co-operate”.

Transparency and the Innovation System

“There’s a lot of focus on transparency in the agenda. COVID-19 raised public awareness of the problem of confidentiality. But there is a lot governments can do on transparency that they haven’t yet done – there also needs to be a strengthening of backbones,” she said. 

Moon added that linking high prices to the underlying innovation system “has never been so front and centre of discussion as it is now”.

“There is an entire strand of the conference on innovation, looking at how governments can change innovation incentives, how they can rewrite the rules that structure innovation and pricing of medicines,” said Moon, of the meeting, which paradoxically is taking place away from the media and public eye..

She added that while the discussion in the WTO’s TRIPS Council over the IP waiver is split along predictable North-South lines, more informal alliances are easier to build at the Forum where there are “challenges common to countries in the North and South and shared concerns vis-à-vis the medicine pricing practices of the pharmaceutical industry”.

Health Policy Watch has seen two discussion papers to be discussed at the Forum, which look at how medicines pricing could be made more “sensitive to health systems’ ability to pay”, and “incentives for pharmaceutical innovation to achieve fair pricing” respectively. These were developed by two technical working groups formed at the last FPF meeting in South Africa in 2019.

Global Framework to Address Pricing

The first paper suggests a global framework to tackle the “unaffordability of medicines and vaccines”. It also flags that the lack of transparency relating to prices and contracts undermines good governance ‘especially when the public expects full accountability for public spending’. 

It highlights the success of cross-border collaborative initiatives in ensuring more affordable medicines, including global initiatives such as Stop TB Partnership’s Global Drug Facility; the Medicines Patent Pool; Gavi, the Vaccine Alliance; and the WHO co-sponsored COVAX global vaccine facility; as well as regional efforts including the Pan American Health Orgqanization’s “Revolving Fund for Vaccine Procurement” and the Beneluxa initiative of smaller European countries, including Belgium, the Netherlands, Luxembourg, Austria and Ireland, to coordinate policies on pharma purchases and pricing.

The second paper argues that ‘“pharmaceutical innovation is a hybrid public and private effort”, with the public sector paying for about 30% of the upfront total investment in pharmaceutical R&D and the private sector paying for about 60% of upfront investment in the later, relatively lower-risk stages, with the remaining 10% coming from sources such donors.

It also flagged the need for “frameworks for global governance”, noting that “the bilateral agreements for COVID-19 vaccines are a sober reminder that public sector stewardship at the national level sometimes may serve narrower national interests at the risk of disregarding larger issues of global health equity”. 

WTO Invites Wide Range of Pharmaceutical Companies 

WTO Director-General Ngozi Okonjo-Iweala

Meanwhile, the WTO’s Wednesday meeting includes various trade ministers, including those from the European Union and the United States, as well as India and South Africa, which are co-sponsors of the WTO proposal to waive intellectual property rights on COVID-19 health products for the duration of the pandemic.

A wide range of pharmaceutical companies are also invited, including representatives from Pfizer, Moderna and Astra Zeneca, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA); the Developing Countries Vaccine Manufacturers Network,  the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Japan Pharmaceutical Manufacturers Association (JPMA).

Speaking at meetings in the US last week, Okonjo-Iweala said that equitable worldwide access to COVID-19 vaccines “is necessary for economic growth and trade to bounce back from the pandemic and that a reinvigorated multilateral trading system would strengthen both the health response and the economic recovery”.

The first session of the  WTO meeting focuses on challenges to “equitable vaccine distribution”, including a focus on export restrictions and trade barriers.

Thomas Cueni, IFPMA Director General, confirmed to Health Policy Watch that his association and a number of its member company experts “have accepted the Director General’s invitation to speak at the WTO event”.

‘“We believe this is an important opportunity to contribute to the DG’s expressed desire to find pragmatic outcomes to increase vaccine production.  We hope to be able to share our experience of the complexities in researching, developing, registering, manufacturing and distributing COVID-19 vaccines,” said Cueni

However, over 240 civil society organisations wrote an open letter to Okonjo-Iweala on Tuesday expressing concern “over the emphasis on industry-controlled bilateral agreements as the primary approach to addressing global production constraints and supply shortages”.

Referring to her “Third Way” approach, which they described as “appealing to pharmaceutical corporations to take voluntary actions”, the organizations said this had “proven to be insufficient in this pandemic”.  

Instead, they proposed that WTO member states approve the initiative to remove “barriers towards the development, production and approval of vaccines, therapeutics and other medical technologies necessary for the prevention, containment and treatment of the COVID-19 pandemic” by supporting the temporary waiver on intellectual property rules.

 

 

Image Credits: WHO, ©WTO/Bryan Lehmann.