WHO Headquarters in Geneva, Switzerland.

One year after the World Health Organization (WHO) declared the coronavirus outbreak a pandemic on 11 March 2020, a new report by the Foundation for Geneva has traced the success and the failures of the WHO and other international Geneva organisations in their response – as well as the implications for the future of multilateralism.

“This deep-dive into 2020, seen from international Geneva, reveals in a crude way the underlying planetary crises: multilateralism at half-mast, states turning in on themselves, the race for drugs and vaccines, and vaccines disrupted by private financial issues and national sovereignty, increasingly noisy alternative truths, etc. But what COVID reveals is also the capacity of the international community to unite to defeat the same common enemy, with a cockpit located mainly in Geneva,” states the report, released this week.

At the time the epidemic was declared to be a “pandemic, the virus had already swept across 110 countries or territories, infected over 110,000 people, and claimed 4,000 lives. A year on, and 117 million confirmed cases later, health experts and researchers have been trying to dissect how the global health body could have reacted differently in the face of the unfolding crisis and how to overhaul it.

With the 70-plus NGOs and international organisations that gravitate around the WHO and make up its global health hub,  international Geneva has been at the front lines of the global efforts to fight the disease.

An Already ‘Weakened’ WHO

WHO has been heavily criticised over its handling of the pandemic. However, before the onset of the pandemic, the WHO was already facing one of the deepest crises of its 73 years of existence. An earlier edition of the Foundation for Geneva (Fondation pour Genève) study conducted before the emergence of COVID-19 revealed that alread by the end of 2019, WHO was financially and politically fragile.

Its limited budget was funded less and less by member states, whose regular, assessed contributions had dropped from 46% of the total budget in 1999 to just 17% last year. Meanwhile, voluntary donations by members and private donors like The Bill and Melinda Gates Foundation now contribute to around 80% of WHO’s overall budget. “This poses an obvious governance problem: who makes the decisions in Geneva? Civil society made up of Member States and WHO or private donors?,” ask the report’s authors, led by Heidi News health journalist Annick Chevillot.

Even before the new pandemic emerged, the organization had yet to fully restore its reputation following the Ebola epidemic in 2014, when it was widely blamed for failing to take leadership and for being too slow in declaring it an international public health emergency: “The WHO is facing a crisis of confidence and mistrust at the dawn of 2020,” explains the report. The organisation “begins 2020 with a new enemy to face: the coronavirus.”

International Geneva’s COVID-19 Response

The international community’s response, at least initially, “overwhelmingly followed the tempo set by the WHO.” More than 20 core organisations based in Geneva or with a direct link to Geneva, like the International Committee of the Red Cross (ICRC), the Global Fund or the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), have played a key role in tackling the crisis, making it “possible to appreciate the extent of the number of actors that have made Geneva an international centre of influence in the fight against the pandemic,” the report finds.

The International Committee of the Red Cross headquarters in Geneva, Switzerland.

However, the pandemic grew into more than a health crisis and organizations working across the fields of human rights, humanitarian aid, trade and the economy were soon implicated, with various calls for funding support.

Despite its clear need for reform, the pandemic also underscored the crucial role of the WHO, the authors say: “The global crisis generated by the pandemic has also shown the importance of multilateralism, of which the WHO is a tool that is as fragile as it is indispensable.”

It was only with the support of the international global health institutions, including Geneva-based “heavyweights” such as the Global Fund and Gavi, that WHO was able to respond to the emergency, and launch one of the greater successes last year: the ACT Accelerator to speed up access to vaccines, treatments and diagnostics against COVID-19.

The Global Health Campus, home to the Global Fund, Gavi, Unitaid, Roll Back Malaria and Stop TB.

Within the ACT Accelerator, its vaccine pillar, the COVAX initiative, has beeen designed to ensure that vaccines reach poor and middle income countries – with the vaccine  rollout having reached the first countries in Africa, including Ghana, Cote d’Ivoire and Ghana, just last week.

“The COVAX initiative is a good illustration of the raison d’être of International Geneva and its ability to find solutions. It offers the prospect of a world that is both interdependent and united,” says Olivier Coutau, delegate for International Geneva at the directorate of international affairs of the canton of Geneva.

Key Achievements

Among some of the other key successes of International Geneva’s health cluster, the report lists:

  • The international randomised clinical Solidarity trials, which “made it possible to evaluate the effectiveness of already existing treatments against Covid-19”, such as dexamethasone.
  • Fundraising that allowed the WHO to raise US$ 241 million (as of January 25, 2021).

“Experts believe that the WHO has risen to the challenge by providing technical and normative guidance, taking the lead in coordinating the scientific response to the pandemic and shaping logistical operations with a number of other international organisations,” says Priti Patnaik, a global health journalist, who is cited in the report.

Read also: Covid-19 vs WHO and the world: successes, failures and hopes a year on

The Road to Reform

The report concludes with a series of recommendations for the “International Geneva” health and development community, but in particular, for the World Health Organization, with respect to its need for reforms.

Observed Antoine Flahault, director of the Institute for Global Health: “The Member States of the WHO, which ensure its governance through the World Health Assembly and its Executive Board, will first have to ask themselves what prerogatives they wish to entrust to the WHO in the event of a health emergency…As long as the WHO General Secretariat has no independent investigative powers in member states, it cannot be expected to play the role of conductor that it is sometimes criticised for not playing.”

WHO’s funding also needs to be reviewed, as explained by Gian Luca Burci, former WHO legal adviser and associate professor of international law at the Graduate Institute of International and Development Studies (IHEID) in Geneva, “because it is dysfunctional. Voluntary contributions, which represent about 80% of the budget, are too volatile. The WHO must have sustainable and predictable funding in the future.”

Partly as a result of such imbalances, Patnaik observes: “the decisions that shaped the international response to the pandemic quickly and decisively shifted from WHO to some donor governments, other actors, including private philanthropists, public-private partnerships, outside the global health field.”

Republished from Geneva Solutions. Health Policy Watch Watch is collaborating with Geneva Solutions, a non-profit Geneva platform for constructive journalism covering International Geneva.

Image Credits: Flickr – Guilhem Vellut, Flickr – US Mission Geneva, Flickr – US Mission Geneva, Global Fund/Vincent Becker.

The Johnson & Johnson COVID-19 vaccine.

With the European Union Medicines Agency (EMA) approval Thursday of Johnson and Johnson’s one-shot COVID-19 vaccine, it now remains to be seen which countries and regions will be the first in line for distribution of the one-jab vaccine. Along with its comparatively low-cost, and ease of storage, the one-shot vaccine could be particularly important to Africa in light of its demonstrated its efficacy against the wily virus variant B.1351, first identified in South Africa.

“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, EMA’s Executive Director, adding, “this is the first vaccine which can be used as a single dose”.

The challenge now, for the pharma company is how to share the bounty.  Johnson and Johnson had last year reached an agreement in principle with Gavi, The Vaccine Alliance, to supply the new COVAX vaccine facility with up to 500 million doses through 2022 – which would go to low- and middle-income countries. It also has pledged to charge a ‘non-profit’ US$ 10 price during the pandemic, making it particularly attractive to lower-income countries. But it also now has major supply commitments to Europe, the United Kingdom and the United States. 

Following the EMA approval, the WHO can be expected to rapidly issue its own “emergency use listing”, clearing the way for the vaccine’s rollout by COVAX.  

Known Vaccine Manufacturing Capacity – J&J

However, the United States this week doubled its own order of the J&J vaccine to 200 million doses. The European Union has also ordered 200 million doses of the shot, with an option for 200 million more. The UK has options for 55 million doses. And, meanwhile, the J&J agreement with COVAX would only supply 100 million doses to the global facility this year. 

The bigger dilemma is that the COVAX rollout is right now almost exclusively dependent on the Astra Zeneca vaccine. And that vaccine yielded poor results in a South African trial of healthy adults, where it failed to demonstrate efficacy in preventing mild and moderate forms of COVID disease. That left South Africa to rapidly pivot to the Johnson & Joshnson vaccine several weeks ago, for the first stage of its vaccine rollout to health workers. Insofar as South Africa was participating with J&J in clinical trials, it had access to at least some initial vaccine supplies.  But other African countries don’t have that luxury.

So in more ways than one, the J&J vaccine’s distribution is likely to be watched as a bellweather of equity – or not. 

Advocacy Groups Call For More J&J Vaccines to be Shifted to Low-Middle Income Countries
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COVID -19 Secured Doses 2021, aggregate and per capita, by countries’ income level

Advocacy groups have recently issued calls for the first cuts of the J&J vaccine to go to low- and middle-income countries through COVAX.

They point out that even South Africa, whose Aspen Pharmacare is set to produce some 300 million doses of the vaccine, will only keep a fraction ( 9 million doses)  for itself.

Meanwhile, the country is on the front lines of the battle with the B.1351 variant, which is slowly creeping northward across eastern Africa – as well well as appearing in Ghana on the west African coast. All of those countries remain almost exclusively dependent on the COVAX supply of AstraZeneca vaccines – complemented by some donations from China, whose vaccines have never undergone a regulatory review.

“MSF is worried that if J&J continues with business-as-usual tactics, countries most affected by this variant will once again be left waiting at the back of the queue,” stated an appeal two weeks ago, issued just ahead of the very first, US Food and Drug Administration, approval.

“For example, South Africa has the highest prevalence of this variant in the world and has been a critical partner in J&J’s clinical trials, yet the country is due to receive a mere nine million of the 300 million doses that will be filled in vials and packaged by a local manufacturer. J&J should right away ensure that South Africa receives, at minimum, enough doses to vaccinate its healthcare workers and high-risk groups, as well as prioritize shipments to other low- and middle-income countries.

While WHO has sought to reassure African nations the the AstraZeneca vaccine can still be effective against serious disease from the variant – that hasn’t yet been demonstrated in a clinical trial – in the same way that the J&J vaccine has been tested.  And as MSF stated, the vaccine’s one-jab regimen and modest refrigerator storage requirements make it particularly attractive in lower-income settings:

“The vaccine could be an important tool in the world’s response to this pandemic – particularly in low-resource settings where MSF works – since unlike the other COVID-19 vaccines being used today… it could require only one dose and could be stored at normal refrigerator temperatures.”

US and Other Rich Countries Keep Piling Up Vaccine Surpluses

On the other side of the Atlantic, meanwhile, noting that some 850 million vaccine doses have been purchased by the United States for an adult population of only 260 million – enough to vaccine all eligible adults three times over. “Prospects of a vaccine shortage giving way to a surplus seem nearer than ever this week,” noted the Washington Post, wryly.  However, with the largest J&J manufacturing base in the United States, the US also can impose export barriers on the vaccine – should it choose to do so.   

And even without an outright export ban, nearly 1.5 billion doses of J&J’s vaccine are already tied up in advance purchase agreements, most (801 million out of 1.439 billion doses) committed to high-income countries.

Dr Paul Stoffels, vice chairman and chief scientific officer at Johnson & Johnson.Pharma sources say that J&J’s Vice Chairman and Chief Scientific Officer Paul Stoffels, the Belgian-born physician who has spearheaded the vaccine’s R&D through its European affiliate, Janssen, is deeply committed to a rapid rollout of the new product in low- and middle-income countries – and possesses a track record on equity issues, with J&J’s prior development of an Ebola vaccine, as just one example.

At the same time, J&J has also received US $1.5 billion from the US government for its COVID-19 vaccine R&D, and the United Kingdom is co-funding a global clinical trial testing a two-dose regimen of the vaccine.

In light of those hefty research investments, the pre-purchase agreements, and the J&J manufacturing hubs clustered in the United States and Europe, it remains to be seen if the US, the EU or other high income countries that have snapped up more vaccines than there are people to jab, might offer to release some of those excess supplies to COVAX, the African Union or even directly in bilateral deals.

If those countries act, it might enable a more rapid rollout of the single-jab vaccine in parts of the world that not only need it the most – but where the vaccine could also have the most impact in halting the global spread of dangerous variants.

Image Credits: Johnson & Johnson, Johnson & Johnson, IFPMA, IFPMA , World Economic Forum.

Proponents to the African Medicines Agency say that it will improve access to safe, affordable medicines – and also ensure a better COVID-19 response.

NAIROBI – Kenya is one of the leading African countries yet to ratify the African Medicines Agency Treaty (AMA) – but a senior official in the Ministry of Health has said that the move  should come soon. 

According to Susan Mochache, the country’s Principal Secretary in the Ministries of Health (MoH), Kenya has already undergone the induction process, and is now waiting for details on operational modalities, which need to be worked out, before ratifying the treaty.

 “The country is now waiting for clarity on whether payments will be made directly to the suppliers and on information on the tax exemption modalities,” Mochache told Health Policy Watch in an interview.

She was referring to questions arising among some African countries about whether the AMA would take on bulk procurement functions – alongside its regulatory role. 

Proponents of the continent-wide approach to medicines regulation say that it will help streamline medicines and vaccines reviews and approvals – also ensuring a better COVID-19 response. 

A unified regulatory mechanism could also pave the way for more efficient bulk procurement of medicines and vaccines, through the African Union or regional blocs of countries – and more local production, its advocates say. 

However, the functions assigned to the AMA through the pending treaty, requiring ratification, are strictly regulatory in nature, the treaty’s architects and proponents underline. 

Dr Margaret Agama-Anyetei, of Head of the Health, Nutrition and Population Division, Africa Union – speaking at the AMA session Wednesday.

“It’s important to focus on Article 6 and what the African Medicines Agency’s specific role would be,” said Dr Margaret Agama-Anyetei, of Head of the Health, Nutrition and Population Division Africa Union, in a panel session on the AMA Wednesday at the African Health Agenda International Conference 2021. She underlined the need for caution in assuming that the AMA could do everything that is needed on the continent – in terms of procurement and production – even though it can set the stage.

Article 6 lays out the primary functions of the African Medicines Agency, which include: coordinating and strengthening initiatives to harmonize medical product regulation; providing guidance on regulation of traditional medical products, and evaluating and deciding on medical products for treatment of priority diseases and conditions, as determined by the African Union and WHO.

African Union Agreed To Create AMA Two Years Ago – But 7 More Countries Need To Ratify Treaty.  

A resolution to create the AMA was adopted at the 32nd African Union Assembly two years ago. However, among Africa’s 54 countries, only 19 countries have so far signed the treaty and only eight countries, mostly in West Africa, have ratified it. 

While that is still three more ratifications since October, the treaty needs to be signed by at least 15 countries to become operational. And meanwhile,  the continent’s biggest countries like South Africa, Nigeria,… and Kenya  remain outliers. 

 In terms of its regulatory function, the agency would function much the same way as the European Medicines Agency (EMA) operates – offering a region-wide umbrella for countries to use in review and approval of drugs and vaccines. 

It may however, also play a role in managing bulk medicines and vaccines procurement – ensuring that the process is cheaper, simpler and faster for the countries that have joined, while also guaranteeing safety in a region where fakes often proliferate.

Kenya Medical Association – AMA Ratification Will Help Expand Vaccines Access 
Teachers aged 50 years and above, are to be the among first to get COVID-19 vaccines in Kenya.

 In a separate interview, Dr. Elizabeth Gitau, CEO of the Kenya Medical Association (KMA), also expressed hopes that the national government will soon ratify the AMA Treaty, saying it would also help improve COVID-19 vaccines access. 

“So, we are waiting and actually do hope that at the end of the day the government will ratify the treaty so that we have more access to vaccines,” she said in a separate interview. 

But, she added, “The Ministry is still going through the decision making process.” 

The KMA has been a key partner in the government’s COVID response, providing technical support to the Ministry of Health, including on prioritization of people who should receive vaccines, advocacy and rollout.  

Its members are participating in the COVID-19 vaccine administration training programmes currently under way in the country – as part of the rollout of the first AstraZeneca vaccines, which were received through the WHO co-sponsored COVAX global distribution facility last week .

AMA would help Kenya Fight Fakes & ‘Grow’ Its Pharma Industry 
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Kenya receiving the first suppplies of Oxford-AstraZeneca COVID-19 vaccines from the WHO co-sponosored global COVAX facility.

Whereas cross-boundary harmonization of the regulatory standards and guidelines in accordance with global standards, and specifically those mandated by the WHO, will be the core function of the AMA, Kenya also stands to benefit in other ways, should it join the agency.

Notably, AMA membership could also help link up Kenya’s pharma producers to a much larger purchasing block, should the AMA’s functions also extend to the supervision of pooled medicines procurement. 

Said Dr. Fred Siyoi, CEO of the country’s Pharmacy and Poisons Board (PPB): “It will help Kenya nurture its growing pharmaceutical industry leading to the realization of the provision in the constitution of the right to health by guaranteeing safe, quality and efficacious locally manufactured medicines.”

For instance, “pooled procurement will enable countries to receive medicines from WHO prequalified, or from AMA prequalified manufacturers,” explained Dr. Siyoi. The PBB Board regulates the pharmaceutical practices in the country in addition to the manufacture and trade of drugs and poisons.

Dr. Gitau concurs, adding:  “Negotiating as a block as opposed to going it alone as individual countries, we are bound to benefit in terms of economies of scale, but also we are more likely to get better access to vaccines with the initiative and possibly better pricing.”

Pooled AMA Procurement Also Would Help “Fight the Fakes” 
The African Medicines Agency’s framework would help combat falsified products

Even though the PPB has its own mechanisms in place for detection and prevention of substandard and falsified products (SF), pooling resources together within the AMA framework will serve to strengthen its programmes further, Siyoi said.

For instance, the national board would benefit from “information sharing from regional blocks on substandard and falsified products,” he says, something which will ensure timely response to risk alerts on medicines of substandard quality and safety.

Dealing with fake medicines has been one of the biggest challenges facing many African countries.

Up to a quarter of the continent’s medicines are substandard or falsified, according to the African Union Development Agency New Partnership for Africa’s Development (AUDA-NEPAD).

One reason why this continues to be a problem for Kenya – just like other countries on the continent – is the lack of adequate personnel.

Understaffing is a big challenge facing the PPB, according to Dr. Siyoi. The limited number of inspectors manning the border points, leaves the agency ill-equipped to cope with vast areas laced with informal border crossings between neighbouring countries through which smuggled drugs find their way.

“This is in addition to modified transport vehicles for concealment of [counterfeit] medicines,” says Dr. Siyoi.

Should the AMA come into being, the PPB hopes to benefit greatly from the technical assistance drawn from the pool of experts at the continental level.

In addition, the Agency will also enhance PPB’s capacity for dossier evaluations and the undertaking of joint Good Manufacturing Practices inspection of drugs being manufactured in Kenya itself. 

Some of these challenges, other pharma sources admit, would indeed be “better be addressed” through the AMA mechanism. 

Oksana Pyzik, Senior Teaching Fellow, Global Engagement Lead and Founder of UCL Fight the Fakes

At no time has the existence of AMA been so critical as today, observed Oksana Pyzik, Global Engagement Lead and founder of the University College London Fight the Fakes initiative, during a Wednesday panel session on ‘Why AMA’ – held under the auspices of the African Health Agenda, International Conference 2021 (AHAIC).     

“AMA is critical now more than ever and ties into the WHO’s patient safety plan directly,” she said. This, she explained further, is a concept which Dr. Tedros Adhanom, WHO’s director general, has been pushing, that without quality medicines, there is no universal health coverage for patients.

Image Credits: MOH_Kenya, AHAIC, Wish FM Radio, Inquirer, Marco Verch/Flickr.

“The future generations are not going to excuse this,” pleaded Kawaldip Sehmi, CEO of the International Alliance of Patients’ Organizations (IAPO). “They will be looking at us and will say, ‘What the hell were they doing procrastinating on their neighbors during a pandemic?”

Sehmi was one of seven speakers from across Africa who convened at an online session on Wednesday, the third and final day of the Africa Health Agenda International Conference (AHAIC), to discuss the prospects for near-term ratification of the African Union treaty to create an African Medicines Agency. a single centralizing regulatory body for pharmaceuticals in Africa.

The creation of the AMA was approved two years ago at the 32nd African Union Assembly, where it was touted as a critical tool that can enhance regulatory oversight of medicines and vaccines across the continent’s 54 countries. But the start of AMA operations have fallen victim to slow bureaucratic procedures in dozens of African countries that have foot-dragged in the required treaty ratification.  

The treaty has been signed by 19 countries but only ratified by eight out of a required 15 countries.  Meanwhile, the glaring absence of a body of this nature has only been more acutely felt during the COVID-19 pandemic, as the panelists highlighted.

Out of the continent’s 54 countries, 19 had signed the treaty ratifying for an African Medicines Agency (AMA), but only 8 out of the required 15 had ratified.

While IAPO’s Sehmi focused on the big picture vision of the AMA as the realization of a pan-African institution, epitomizing teachings of great African thinkers like Dr Kwame Nkrumah, the Ghanaian independence leader and first prime minister, other panelists detailed the nitty gritty  practical problems that AMA could help resolve  – focusing on the heart of concerns, African patients.

Take the case of sickle cell anemia.   Speaking at the AMA session, Mary Ampomah, President and CEO of the Global Alliance of Sickle Cell Disease Organisation (GASCDO) emphasized the critical role a body like AMA could play in helping sickle cell patients access more reliable and affordable drug supplies.  This has been a big problem in contempoary Ghana where, despite the existence of treatments like hydroxyurea for over three decades, patients could not access them prior to 2019 when Novartis finally intervened to create a supply channel for west African countries.

Mary Ampomah, President and CEO, Global Alliance of Sickle Cell Disease Organisations (GASCDO)

Going a step further, she asserted that the creation of a single regulatory authority would also help stimulate more local manufacturing – to supply a bigger market: “I think AMA will be helpful here because we know that when drugs are locally manufactured, they become cheaper and therefore accessible to patients,” she said.

Better regulation for Better Medicine

Oksana Pyzik, founder of the University College London Fight the Fakes,’ campaign, said that the AMA would assist in the “identification, prevention, detection and response strategies” in delivering quality medication across Africa. 

Oksana Pyzik, Senior Teaching Fellow, Global Engagement Lead and Founder of UCL Fight the Fakes

Pyzik spoke of how the COVID-19 pandemic had highlighted the need for a regulatory body such as the AMA to fill gaps and inconsistencies in the current patchwork of regulations that exist among the continents five regional regulatory authorities and dozens of national authorities. 

Citing the proliferation of false information surrounding the pandemic, which has affected people across the globe, she explained that in Africa “the lack of national regulatory and technical capacity has been one of the weak points around [the pandemic], fueled with misinformation that also then leads to people outside of traditional marketplaces, able to purchase medicines.”  This, in turn, places patients in grave danger – because they secure medications through channels where the products are not vetted and tested. 

Dr Eva Wangechi Mubia Njenga, Chair of the Non-Communicable Diseases Alliance of Kenya (NCDAK), further explained that the COVID pandemic has brought to a fore numerous “fake” products, including not only medicines, but also substandard personal protective equipment ( PPE), like masks, gloves, etc, which have entered into circulation.

Philip Tagboto – Chair of the Association of Ethical Pharmaceutical Industries – Moderates AMA Sesseion in the ”virtual space” of the Africa Health Agenda International Conference  2021

Fake vaccines, meanwhile, have already made their appearance.  In November 2020, some 400 ampoules of fake COVID-19 vaccines – equivalent to about 2,400 doses, along with a large quantity of fake 3M masks, were confiscated by police in South Africa working with the global police coordination agency, Interpol. The cross-border investigation led police in China to the manufacturing premises, where arrests of a number of Chinese nationals were made just last week – and a further 3,000 fake vaccines were seized. 

And Interpol Secretary General Juergen Stock said that this is only the tip of the iceberg when it comes to COVID-19 vaccine related crime. Efforts by bodies like the France-headquartered Interpol could be bolstered by AMA to support such cross-border successes, according to several panelists.. 

Through an Africa-wide regulatory body like AMA, processes like “market surveillance” and “supply chain security” could be implemented to better protect patients, Pyzik and other panelists stressed.

Big Pharma and Aid as ‘Gifts’ 
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COVID-19 vaccines arrive in Guinea – distinguishing fakes from authentic vaccines could become a serious problem as Africa’s vaccine rollout amplifies.

Dr Njenga also said that Africa’s inadequate [regulatory] barriers have left it vulnerable to the possibility of authentic, but still substandard, ineffective or defective vaccines and medicines could enter the market, by way of “gifts”. In February alone, Guinea accepted a donation of 200,000 vaccines from China, which has offered vaccines to over 50 countries around the world – even though China’s vaccine developers have yet to publish peer-reviewed studies of any of their products, or submit them for review by stringent regulatory agencies abroad. 

Exacerbating the problem, said Njenga, is the fact that vaccine know-how is difficult to share and transfer – with big pharma compnies, mostly based in high-income countries,more  eager to sell their products to the highest- bidders – leaving low- and middle-income countries out of the loop. It’s thus no surprise that vaccines entering the continent are either “unregulated, or to a lesser extent, what doesn’t meet regulatory standards in the West is often offered or passed on to the African continent,” said Dr Njenga.

African Medicine for Africa, the World

Another important aspect of the AMA’s work may be improving the supervison and regulation of African traditional medicine, said Isaac Nii Ofoli Anang, chairperson of the African Regional Office of the International Pharmaceutical Students’ Federation (IPSF), “especially in a time when we want to improve access and safety traffic and traditional medicines to help augment their production and distribution across the continent.”

Isaac Nii Ofoli Anang, Chairperson, African Regional Office, International Pharmaceutical Students’ Federation (IPSF)

Anang said that for IPSF, AMA serves two key roles, that of education and that of science. With respect to education, as in the case of African traditional medicine, the agency would serve to streamline education of a medicinal regulation framework. 

Speaking about science, he said AMA would serve to harmonize the “scientific processes to improve on our local drug production and distribution pharmacies and pharmacies.”

Civil Society and Free Trade Concerns

With countries still stalling in the ratification process, Dr Njenga placed the responsibility on civil society to demand this continental regulatory body. 

She painted a grim picture of the alternatives, pointing to the double-edged sword of Africa’s recently agreed, Free Trade Agreement (FTA) which facilitates faster and more efficient trade across Africa’s countries. As pharmaceuticals are amongst the most traded products in Africa, in the absence of an AMA, the FTA could actually open the doors wider to the proliferation of poor quality and poorly regulated pharmaceuticals being trading across several borders with little to no control or recourse, to the potential detriment to all Africans.

Moving beyond the need for ratification, per se, however, she stressed that the next step needed for the AMA will be an “operational business plan.”

Image Credits: IFPMA, A, AHAIC, srb news.

A study of people taking regular, low doses of aspirin found that the aspirin users were 29% less likely than others to test positive for COVID-19, as well as being less prone to serious disease and its “long COVID” after-effects.

The new peer-reviewed study, published in The FEBS Journal of the Federation of European Biochemical Societies, was led by an Israeli team associated with one of the country’s leading public health funds as well as a leading medical school and hospital.

Some of the same team members also were among the first to identify, last year, a link between low Vitamin D levels and higher COVID infection risks. 

In the observational study on aspirin and COVID, the team reviewed the medical records of 10,477 patients who had been tested for SARS-CoV2 infection between February and July of 2020. 

They identified a subgroup of over 2,000 patients who took 75 milligrams of aspirin regularly to prevent cardiovascular disease – and compared them with a similarly sized sample of people who didn’t regularly take aspirin doses – adjusting statistically for any differences in age and health status.  

Among people who had tested COVID-positive, the proportion of those regularly taking aspirin (or statins) was significantly lower, as compared to the group of people who tested COVID-19-negative group, the study, published in The FEBS Journal, of the Federation of European Biochemical Societies.  

People who had purchased, prior to their COVID test, at least 3 prescriptions for aspirin and statins were also less likely to be COVID-infected than those who did not.   

Among those who tested COVID positive, the aspirin users were also likely to have a shorter illness — by about two days — as determined by the length of time between their first positive COVID test and a negative test.  And they were less likely to suffer from aftereffects of the coronavirus, in terms of chronic health issues identified in follow-up. 

 The focus of the study was on aspirin users at risk of cardiovascular disease – but not chronically ill. 

“This observation of the possible beneficial effect of low doses of aspirin on COVID-19 infection is preliminary but seems very promising,” lead author, Eli Magen, of Barzilai Hospital, was quoted as saying in an Israeli news outlet.

“We were really excited to see a big reduction in the proportion of people testing positive, and this gives a promising indication that aspirin, such a well-known and inexpensive drug, may be helpful in fighting the pandemic,” added Milana Frenkel-Morgenstern of Bar-Ilan University 

“This finding with regard to ‘long COVID,’ a phenomenon that is a real concern, is very important,” she added.   While the mechanism by which aspirin might reduce disease risks and seriousness would require further study, she speculated that it was associated with the medication’s anti-inflammatory qualities. 

In addition to reducing inflammation, other observational studies on aspirin have also suggested that the century old medication, originally derived from willow bark,  can help play a role in preventing infections from other single-strand RNA viruses, similar to the coronavirus, as well as in preventing some forms of cancer. 

Frenkel-Morgenstern, the corresponding author on the aspirin study, also set a precedent in her observational study last year that found an association between low levels of Vitamin D and increased risk of COVID infection.  

Image Credits: University Health News .

Almost one in three women experience physical and/or sexual violence across the course of their lifetimes. And over the past 12 months, more than one in ten women suffered from physical and/or sexual intimate partner violence, according to a new WHO-led report on gender-based violence, published just a day after International Women’s Day.

Gender-based violence is “unequivocally pervasive” across all regions of the world, putting the health and well-being of billions of women and girls at risk, reveals the most comprehensive WHO report yet on violence against women and girls. 

The results, said the WHO’s director-general Dr Tedros, paint a “horrifying picture” of out-of-control levels of violence against women by their intimate partners, as well as sexual violence against women by family, friends or strangers,  in many parts of the world. 

Young girls are unfortunately not immune; one in four adolescents aged 16-19 that have been in a relationship were subject to ether physical or sexual violence, found the report. In addition, 16% of women aged 15-24 reported physical or sexual violence over the past year.

 Given that the report was compiled from data preceding the pandemic, its estimates do not reflect the ways in which lockdowns, disruptions to essential services, and economic turmoil have exacerbated violence against women. But available data from the pandemic year suggest that many forms of violence against women have indeed risen.

Said UN Women Executive Director Phumzile Mlambo-Ngcuka: “It’s deeply disturbing that this pervasive violence by men against women not only persists unchanged, but is at its worst for young women aged 15-24 who may also be young mothers. And that was the situation before the pandemic stay-at home orders.”

“We know that the multiple impacts of COVID-19 have triggered a ‘shadow pandemic’ of increased reported violence of all kinds against women and girls. Every government should be taking strong, proactive steps to address this, and involving women in doing so”, she added.

The report was produced by WHO on behalf of a the United Nations Inter-Agency Working Group on Violence Against Women Estimation and Data (VAW-IAWGED), which includes representatives from UN Women, UNICEF, UNFPA, UNODC, and UNSD. 

Phumzile Mlambo-Ngcuka, UN Women executive director

Pandemic Has Exacerbated Violence – And Can’t Be Stopped Just With A Vaccine 

“Violence against women is endemic in every country and culture, causing harm to millions of women and their families, and has been exacerbated by the COVID-19 pandemic,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, also appearing at the briefing.

“But unlike COVID-19, violence against women cannot be stopped with a vaccine. We can only fight it with deep-rooted and sustained efforts – by governments, communities and individuals – to change harmful attitudes, improve access to opportunities and services for women and girls, and foster healthy and mutually respectful relationships.”

Stark Differences In Violence Between Rich & Poor Countries

These global figures, however, hide “very stark” differences between rich and poor countries, emphasised WHO’s Claudia Garcia Moreno, who led the preparation of the report, speaking at a press conference on Tuesday.

In the poorest countries of the world, intimate partner violence affected almost 40 % of women across their lifetime, almost twice that of high-income countries. The highest levels of violence were localized to regions of Oceania, Southern Asia and Sub-Saharan Africa – ranging from 33% to 51%. But the trends were unacceptably high everywhere”, said Moreno. According to the report, lifetime prevalence of intimate partner violence reached 31% in the Eastern Mediterranean, 25% in the Americas, 22% in Europe, and 20% in the Western Pacific.

 “The rates are really unacceptably high everywhere, but we see the highest prevalence in the least developed countries,” said Moreno in a separate interview  that accompanied the report. 

“In particular, the regions of Oceania, Sub-saharan Africa and South Asia, and also when we look at countries we see that it’s the poorer countries, and countries which have been affected by conflict recently tend to have among the higher rates.”

Most Robust & Largest Dataset To Date 

The report, which draws on data from 161 countries for intimate partner violence and 137 countries for non-partner sexual violence, was collected across nearly two decades, between 2000 and 2018. As such, it is comprises the largest and most robust dataset on violence against women yet. 

At the same time, many of its findings echo those of an earlier WHO report on violence against women, published in 2013, which was based on data from 1983-2010. 

However, strictly speaking, the estimates of violence levels reported on in 2013 are not comparable with the latest figures – because they were calculated using different methods, said Moreno at Tuesday’s press conference; but she did note that the figures seem to have stayed relatively constant since they were last measured.

“We do not want to compare the estimates from 2013 with these findings [from 2021] because the methodology has changed, and the availability of data is substantially changed, and the quality of the data substantially changed,” said Moreno.

Claudia Garcia Moreno leads the World Health Organization’s work on violence against women

Cross-Country Comparisons Key Advantage 

Even so, one key feature of the new report is the fact that data has been assessed in a way that allows for key cross-country comparisons of violence levels and characteristics  – adjusting for differences in national survey methodologies.  

In addition, the report presents the first-ever global and regional estimates of levels of sexual violence against women by men other than their intimate partners.

The findings suggest that at least 6% of women above the age of 15 suffered from sexual violence by someone other than a husband or intimate partner at least once in their lifetime. Like all surveys that attempt to measure sexual violence against women and girls, this reportedly slim figure is likely to represent a “substantial” underestimate of the true extent of non-partner sexual violence, emphasized the study authors.

The report warns that unless urgent action is taken, the world will fail to reach one of the key targets of Sustainable Development Goal (SDG) 5 on gender equality which calls on countries “to eliminate all forms of violence against women and girls in the public and private spheres (SDG 5.2).” by 2030. 

Impacts of Violence Are Physical & Psychological 

Violence against women has severe impacts on the health of their children

Violence against women deals a severe blow to mental, sexual and reproductive health, and contributes to other chronic health conditions, unplanned pregnancies, as well as poorer health in the children of affected women – which are more likely to perpetuate or experience violence in their lifetime than children of women that are unexposed to violence.

However, the report doesn’t go so far as to quantify the total number of deaths and disabilities that arise from the number of women who are raped, beaten or sexually assaulted every year. 

That data is compiled by the United Nations Office on Drugs and Crime, which in 2017 found that some 87,000 women were intentionally killed in 2017, amounting to some 137 deaths of women every day, of which more than half were killed by intimate partners or family members.

Some Progress In Measurement of Violence Apparent

While the WHO led report presents a “very bleak” picture, the report does highlight some good news, noted Moreno. Since 2010, the number of nations with nationally representative surveys on violence against women has doubled – to 161 countries from 82, which is a key step forward, she said in an encouraging note.

Still, quite a few regions and countries lack any data whatsoever on violence against women, while others have “one or two data points” that are more than a decade-old. These patterns are most apparent in regions of South-East Asian and Eastern Mediterranean Regions for intimate partner violence; and also in the Eastern Mediterranean Region for non-partner sexual violence.

Data on violence is especially scarce in humanitarian settings and conflict zones, and lacking for some sub-groups of women – including older women, women with disabilities, migrants, Indigenous and ethnic minorities, and transgender women, noted the report. 

Even when countries adopt population-based surveys, it is challenging to assess their quality, as important contextual details relating to the interview process are rarely explicitly stated in survey results – whether interviewers were trained to collect data in a private space in a non-judgmental way, in the absence of male counterparts, and whether they provided referral services, is typically unclear, muddling our understanding of the quality of data gathered. 

Another issue with existing surveys is their failure to adequately capture the full spectrum of sexual violence, typically skewing results towards forms of violence that are easier to measure than others, such as rape. As a result, other forms of violence, like psychological violence, often slip under the radar. 

Surveys also lack the granularity to distinguish between different perpetrators of violence (e.g. former spouse, existing intimate partner, family member, friend, stranger), the type of sexual violence commited (e.g. rape, attempted rape, other sexual contact, non-contact sexual abuse), and fail to disaggregate data by age group in a consistent way. Meanwhile, some forms of violence – like cyberviolence or sexual harassment – are rarely measured at all in surveys, which is why they were not included in the report. 

Strategies For Reducing Violence Against Women And Girls

Men in Burkina Faso practice domestic work to ease the burden on their wives

Despite these issues, recent research has uncovered an extensive palette of evidence-based interventions that can help prevent violence in just a few years, emphasized Wendy Morton from the British Parliament, who also spoke at the WHO briefing Tuesday. 

She was referring to promising results from the UK-funded What Works to Prevent Violence Against Women and Girls evaluation programme – which found that interventions in homes, schools and communities can reduce violence against women by 50% in a few years.

 “We will not be deterred by the scale of the problem,” said Morton. “We now have the evidence that violence is preventable, and we know what approaches are effective. Together, we have the opportunity and the responsibility to translate this evidence into long-term prevention.”

Legal responses can also help curb violence against women and girls, added Phumzile Mlambo-Ngcuka, UN Women’s executive director, noting that, worldwide, 155 countries have already passed laws related to domestic violence, and 140 have put in place legislation to prevent sexual harassment in the workplace.

But policies need to go beyond broad generalities about reducing violence against women and instead empower them in matters related to inheritance, property rights, divorce, child custody, and more, Moreno stressed. 

Laws against domestic violence, “need to be also coupled with laws and policies that do not perpetuate discrimination and not just laws on violence against women, but laws around inheritance or property rights laws around divorce or child custody…as well as interventions around economic opportunities and economic empowerment,” she said.

Hospital in Pakistan offers counselling for women experiencing gender-based violence.

Scarce Resources Bad Excuse To Not Fight Violence Against Women 

One barrier to change is, of course, the costs of providing better services in low- and middle-income countries that both lack strong public and mental health systems – and where violence against women may be most prevalent.  Those challenges have redoubled during the pandemic.  

But communities, families and parents can still do “a lot” to fight violence against women, WHO’s Assistant Director for Family, Women, and Children, Princess Nothemba (Nono) Simelela said:  

“There’s a lot that communities can do on their own without looking at big resources,” she said. “I just want to highlight that it’s not only about money and reports, it’s about us as a people, and how we treat ourselves, others and those we see and love.”

“Governments can help you, but you as a partner can take responsibility for your well-being with your family.”

Princess Nothemba Simelela, WHO’s Assistant Director for Family, Women, and Children

Image Credits: UNICEF/Noorani, UNFPA Moldova/Anastasia Pirvu, UNFPA/Ollivier Girard, WHO / Blink .

Press briefing after Chatham House discussion on COVID-19 vaccine supply chain bottlenecks and solutions

A two-day summit of the world’s top pharma and public health sector players to address COVID-19 vaccine supply chain and manufacturing bottlenecks ended on Tuesday with agreement that large vaccine manufacturing scale up potential exists – even in 2021 – but the route is complex and there are no easy fixes. 

And most immediately, there are  “increasing signs of strain within supply chains” as vaccine manufacturers scramble to procure some of the same raw material inputs and equipment, said. Richard Hatchett, CEO of the Coalition for Epidemic Preparedness (CEPI), which has seeded key  COVID-19 vaccine R&D investments, which are now driving the global vaccine distribution platform, COVAX.  

“Companies are beginning to report shortages of critical raw materials, critical consumables, even equipment, that is necessary for vaccine manufacturing,” said Hatchett, at the close of the summit, hosted by the UK-based Chatham House.

He pointed out that the usual global production of vaccines was between 3.5 – 5.5 billion doses whereas the aim for this year was to produce 14 billion COVID-19 vaccines.  A background paper produced out of the summit discussions  “Towards Vaccinating the World” provides one of the most detailed papers to date on the landscape of current vaccine supply chain bottlenecks, manufacturing challenges and possible solutions.  

The paper warns that already “it has become apparent that many COVID-19 vaccine input supplies of raw and packaging materials, consumables and equipment are in short supply which may result in several COVID-19 vaccine manufactures not being able to meet their current vaccine manufacturing commitments.

“Such shortages will also impact the ability to manufacture other lifesaving vaccines and biologics. Mechanisms to ensure input supplies for current and increased manufacturing capacity intent need to be put in place with short, medium and longterm solutions.”

Vaccine Producers by Continent

Largest Ramp-up of Vaccine Manufacturing World Has Ever Seen

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers (IFPMA) added that few people fully understand the scale of the task at hand. 

“This is the largest ramping up of manufacturing the world has ever seen,” said Cueni. “I have to admit to myself, if you would have asked me three months ago, I would have said there is no idle capacity. Everybody is already doing the maximum of that they can.

“But just over the last few weeks, we have seen new players, experienced players in pharmaceutical manufacturing coming in. We have also seen an amazing amount of collaboration and togetherness, for example, between innovative manufacturers and developing country manufacturers.”

Cueni said the meeting delved into granular detail about the kinds of technology transfers would be needed to fast-track vaccine manufacturing – pointing to the importance of being able to move skilled workforce around, political will and regulatory harmonisation. 

“I think we all extremely grateful for the incredible work regulators do. It is amazing how fast we saw safe and effective vaccines approved,” said Cueni.

COVID -19 Secured Doses 2021 – by high income (HIC), upper middline income (UMIC) and low income (AMC) countries 

Technology Transfer For Vaccines More Complex Than for Chemical Compounds

While access groups have focused in great detail on the issues of patents and IP as a barrier to rapid manufacturing scale-up, the summit participants stressed the ways in which knowledge transfer and the presence of a skilled workforce are preliminary requirements for any expansion of capacity – along with sensitive and sophisticated infrastructure needs.

“Unlike pharmaceuticals which are chemistry-based products, the complexities of biological vaccine operations are still of higher challenge,” said Rajinder Suri, CEO of the Developing Countries Vaccine Manufacturer’s Network (DCVMN).

“You have a drug substance, … you have a drug product. And then you have the final fill and finish. So at the drug substance level itself, there are several complexities which are involved, whether it is in terms of platform technology; whether it is in the form of capacity,… so there are so many issues which one has to really understand, before getting into the tech transfer. And then, matching the scaling up of the facility, whether in terms of fill and finish, or final product.

“Again, this has to be fully understood before getting into this kind of a tech transfer agreement with other companies or other countries. So, the ability of an individual company to absorb technology and have trained manpower to really understand what are complexities and how to take it forward, are also going to be the key challenges.”

Developing Vaccine Manufacturing Capcity in LMICs – Long Term Goal

And while developing vaccine manufacturing capacity in low and middle-income countries was important, said Cueni, this was a long-term goal.

The most immediate challenge is to simply find ways for the world to produce more COVID-19 vaccines – and that meant looking at every corner of the planet “where you have the know-how, expertise and equipment.

Sai Prasad, President of the DCVMN, agreed, saying: “With COVID-19, we need to ensure vaccines as soon as possible so for 2021 and 2022, we need to go where there is existing capacity, human resources and know-how”.

Prasad also added that technology transfer was “less about intellectual property and more about knowledge transfer”.  He was referring to the South African/Indian joint proposal for an intellectual proper waiver on COVID-19 related health technologies, not before the World Trade Organization – which advocacy groups say would unlock supply bottlenecks.

Rasmus Hansen from research company AirFinity added that manufacturers also were concerned about “a mismatch between supply and demand” – in which ramping up too fast might even create excess capacity.

“Will we get to a point of over-supply?” asked Hansen. He said that manufacturers that were considering expensive and technologically complex investments in vaccine production, were also asking what their level of long-term investment should be.

Meanwhile, Hatchett said he was concerned about the potential for the United States to use its Defense Production Act to reserve scarce vaccine ingredients for its own use, saying this, too, would “disrupt vaccine manufacturing” at a more global level.

Solutions for ramping up vaccine manufacture – and technology transfer 

Summit Was Not About ‘Matchmaking’ and there were ‘No Blind Dates’  

Cueni said that while “everybody who was at the summit, is keen to follow up, this summit was not a dating meeting.”

His comments were a direct rebuttal to a WHO statement last week by Director General Dr Tedros Adhanom Ghebreyesus that the global health agency stood ready to play “matchmaker” between pharma innovators and manufacturers in order to increase vaccine production more  rapidly.

“There were no blind dates or things like that,” he said noting that the virtual nature of such a summit and the legal constraints companies already operate under would discourage “matchmaking” in particular.

At the same time, he said he is optimistic about the potential of seeing more partnerships evolve that can address the global bottlenecks seen now.  ” I do expect  we will see more partnerships, we will see more surprising announcements about new capacities found,” declared Cueni.

“But also we will see we will see the longer term dialogue about how to improve on tech transfer,” he added. “I think there’s a commonality of views I’ve already had discussions with several manufacturers from our side afterwards, and there’s a willingness to to engage in that.

“In terms of the tech transfer, it’s already happening though, and the expansion of capacity has taken place because you have partnerships, for example between innovative manufacturers and developing country manufacturers, both bringing their respective competencies competencies to the fore. But we also had of course, a number of high level government representatives there. I think also understood that they can help to address inefficiencies.”

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Image Credits: IFPMA .

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The pandemic is a call for a comprehensive, multi-sectoral approach to ensure that Africa is prepared for future outbreaks.

African governments, the private sector, and development partners need to invest more in health and health systems to intensify the fight against the COVID-19 pandemic and any future disease outbreaks, according to health experts speaking at the African Health Agenda International Conference (AHAIC) on Tuesday.

The experts agreed that a comprehensive, multi-sectoral approach is needed to not only ensure that Africa does not face crippling effects of another pandemic, but that well-planned and integrated responses to improving health securities and building health societies are adopted.

Dr Matshidiso Moeti, the World Health Organization’s Africa Director, said the pandemic was a massive wake up call for Africa’s health systems, both revealing glaring gaps in health security and health systems and highlighting the lack of funding in the advancement of the health eco-chain.

“A big issue is investment in health and financing of health. We have noticed a stagnation per capita in most African countries in the past few years,” said Moeti, adding that the WHO had recommended that countries increase the funding per capita from $60 to $90 in lower income countries and $170 in higher income countries.

African governments, the private sector and development partners need to invest more in health and health systems to intensify the fight against the COVID-19 pandemic and any future disease outbreaks, according to health experts speaking at the African Health Agenda International Conference (AHAIC) on Tuesday.

Speaking under the theme Build Back Better: Health Security Beyond COVID-19, the plenary on the second day of the conference focussed on how governments, private sector entities, civil society organizations and development partners need to put in place long term, country-led strategies to prevent another widespread disease outbreak and ultimately build back better post-COVID-19. 

The experts made a case for urgent, concrete action for governments and health leaders to take in order to strengthen health systems, prepare and protect populations; highlight existing response and preparedness strategies to mitigate the risks of future disease outbreaks and build resilient health systems. 

They also called upon health leaders, policy makers, pan-African organizations, academic and research institutions, and global organizations to commit to disease outbreak preparedness and recovery measures.

Provide Environments Conducive for Investment

Greg Perry, assistant director general of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), called for greater investment in health, universal health coverage, health insurance, health systems and manufacturing.

“Investment in health is fundamental for economic sustainability…and all economic actors should be on board,” he said.

The need for investment was paramount to the fight against pandemics, but Perry said the continent should be cognisant of some of the challenges faced in attracting investments and should work on addressing such.

These include fragmented markets, regulatory challenges, skilled workforce and proper environments to enable investment, said Perry.

He pointed to how, even if African countries produce local vaccines, they might be dependent on open borders to import components of what will be produced locally.

“A lot of these challenges are pre-existing, but a lot of work has been done to address them,” he said, adding that a mind shift was taking place everywhere on how best to move forward.

Perry further emphasised the need for an improved culture of pandemic preparedness and solidarity between countries.

Moeti echoed this sentiment and said a comprehensive, multi-sectoral approach needed to be adopted to “protect health, the economy and the most vulnerable people”. “We need to put safety nets in place.”

Where Did We Go Wrong With The COVID-19 Response?
African Health Agenda International Conference (AHAIC) – Plenary 2: Build Back Better – Rebuilding Africa’s Health Systems Beyond COVID-19
Clockwise: Dr Solomon Zewdu, Patricia Vermuelen, Dr Ngcobo, WHO Africa Director Dr Matshidiso Moeti, Director of the Africa Centres for Disease Control and Prevention Dr John Nkengasong

John Nkengasong, Director of the Africa Centres for Disease Control and Prevention, said that in addition to investing in health, countries need to interrogate improvements that could be considered to fight the pandemic. 

This would include investigating “what went wrong, what went right and what we can do better”.

One year, two months into the pandemic, Nkengasong is of the view that there needs to be a holistic approach to better understand pathogens, population, policy and politics. More importantly, he said that if policy and politics are not aligned then whatever work is done in pathogens and population would be of little use.

“The fight is still ahead…now we have political leadership that is quite adamant about being aligned to hold downstream accountable,” said Nkengasong.

Lessons learnt from previous outbreaks, including Ebola, should have been adapted to fight the pandemic which to date has globally claimed the lives of more than 2.6-million people.

“We need to invest in endemic diseases…if we get those systems right then we can fight any pandemic. This pandemic has shaken us to the core …still a lot of work needs to be done.”

Rapid Vaccine Delivery Should be Celebrated

While the pandemic had devastating consequences, Dr Martin Fitchet, Global Head of Research & Development for Johnson & Johnson Medical Devices, said it was not “all bad news in terms of response” as there was “remarkable co-ordination” between governments and the private sector to deliver vaccines to the markets in reasonable time.

“Very rapid decisions were made for obvious reasons…we need to continue to invest to ensure that we have the appropriate response,” he said, quipping that: “Let’s just do it and not say we are going to do it.”

Image Credits: African Development Bank , Amref Health Africa.

Healthcare worker in Chile opens up the Chinese-developed “CoronaVac” COVID-19 vaccine.

The Chinese-developed “CoronaVac” vaccine against COVID-19 vaccine triggers a sixfold reduction in neutralizing antibody response against the P.1 variant first identified in Brazil, according to a pre-print study published last week, while the Oxford/AstraZeneca vaccine is likely effective against the variant of concern. 

These findings come as hospitals in northern Brazil are increasingly overwhelmed and overcrowded; the country is reporting record high death rates; and the P.1 variant is becoming dominant in most of the country. 

The CoronaVac vaccine, produced by the Chinese pharma firm, Sinovac Biotech, is Brazil’s principal vaccine, with 120 million doses purchased by the government. CoronaVac accounts for over 70% of COVID-19 vaccines now being administered in Brazil. 

Some 10.83 million doses of COVID-19 vaccines have been administered in Brazil, but the virus continues to rage out of control, nearing record highs in daily cases, with 80,508 new cases reported on Sunday. With 2.68 million people fully vaccinated – 1.28% of the population – it could be too soon to draw conclusions about the efficacy of the vaccines in preventing transmission and infection in Brazil.

The new COVID-19 cases reported in Brazil. The country is reaching record high daily cases, with a seven day average of 66,869 new cases in March.

The P.1 variant was discovered in Manaus City in Brazil in early January and has several mutations – E484K, K417T, and N510Y – that are also present in the B.1.325 variant, which is circulating around the United Kingdom and South Africa and has been linked to higher transmissibility. 

The small-scale study of the CoronaVac vaccine, produced by the Chinese firm Sinovac Biotech, was conducted by researchers in Brazil, the United Kingdom, and the United States, found that the plasma from eight individuals vaccinated with Sinovac’s vaccine “failed to efficiently neutralize” the P.1 SARS-CoV2 variant. 

“Our data suggests that the SARS-CoV2 lineage P.1 can escape from neutralization antibodies elicited during infection or immunisation with previous circulating viral variants,” said the authors of the study. 

The neutralizing capacity in the blood plasma was six times lower against the P.1 variant compared to earlier lineages. According to the authors, the partial immunity against new variants could suggest that reinfection of previously infected or vaccinated individuals could occur. 

AstraZeneca’s Vaccine is Effective Against P.1 Variant, Says Preliminary Data

In contrast to Sinovac’s CoronaVac vaccine, early results from a study conducted at the University of Oxford indicate that the Oxford/AstraZeneca COVID-19 vaccine is effective against the P.1 variant. The results of the AstraZeneca study, which have not yet been made public, were shared with Reuters. The data indicates that the vaccine would not need to be modified to target the variant. 

This encouraging news follows the earlier release of data from a South Africa study, suggesting that the AstraZeneca vaccine was unable to protect people against mild and moderate cases of the B.1.351 variant of the SARS-CoV2, first detected in South Africa and bearing similarities to the P.1 variant. The full study will likely be released in March.

Sinovac Vaccine To Be Rolled Out Across Several Countries in Latin America and Asia
A second batch of 6.5 million doses of the Sinovac vaccine arriving in Turkey in late January.

Along with Brazil, mass vaccination drives of CoronaVac have begun in China, Indonesia, and Turkey and the vaccine has also been approved for emergency use in Colombia and Mexico. 

The efficacy rate of the vaccine against SARS-CoV2 was only 50.3%, based on late stage clinical trial results from Brazil. However, its developers claim that the vaccine is still 83.7% effective for more serious cases requiring medical treatment, and 100% effective in preventing hospitalisation. 

Sinovac previously said that the firm is looking into developing a vaccine for the variants or offering booster shots to extend protection. Both of these options could be developed fairly quickly, the company says.

“It’s like there’s this thief whom we’ve already caught,” said Yin Weidong, Sinovac’s CEO, in an interview with the Chinese government-controlled TV channel, CGTN, last week. “Even if it’s mutating, we can totally use the current research and production capacity to effectively develop a vaccine for the new variant.”

Risk Posed By P.1 Variant Extends To Other COVID Vaccines

Meanwhile, the P.1 variant, which has spread to more than 20 countries, poses potential risks to several other COVID-19 vaccines as well as possibly being more fatal. 

According to a pre-print study conducted by researchers at the University of São Paulo, Imperial College London, and the University of Oxford, the P.1 variant is between 1.4 and 2.2 times more transmissible than previous SARS-CoV2 lineages. 

The researchers estimate that P.1 evades 25% to 61% of protective immunity provided by infection from a different strain of the virus. 

“There was also evidence of an increase in mortality risk but whether this is due to P.1 or the extensive healthcare collapse Manaus has experienced remains uncertain,” said Thomas Mellan, a research associate at Imperial College London and co-author of the study, in a press release. 

“Uncertainty in the ways SARS-CoV2 is changing and implications for vaccine design calls for much more sequencing and analysis of virus genomes globally,” said Ester Sabino, professor of infectious diseases at the University of São Paulo and co-author of the study.

Image Credits: Twitter – Chinese Embassy Manila, Pontificia Universidad Católica de Chile, New York Times, Twitter – TRT World Now.

Professor Sarah Gilbert, University of Oxford, co-founder of Vaccitech and the developer of the Oxford/AstraZeneca vaccine against COVID-19

The structural barriers to a faster and more equitable COVID-19 vaccine roll-out go far beyond the issue of patents, declared two of the world’s leading vaccine researchers and pharma execs at a WHO event on Monday evening. 

Sarah Gilbert, developer of the Oxford/AstraZeneca vaccine and Özlem Türeci, chief medical officer of BioNTech, the developer of the cutting-edge Pfizer-BioNTech mRNA vaccine, were speaking at a WHO media event honouring women in global health on the occasion of International Women’s Day. 

But their statements about the challenges of vaccine distribution – made at the tail end of a WHO press conference – illustrate a certain disconnect between WHO Director General Dr Tedros Adhanom Ghebreyesus’ recent offer to act as a “matchmaker” between pharma innovators and manufacturers to ensure faster production and more equitable distribution of new COVID jabs – and the hard-nailed infrastructure and logistical challenges actually faced – which are not a traditional area of WHO expertise.

“Delighted to be joined by 2 women who created 2 of the #COVID19 vaccines now being rolled out” – @DrTedros tweets at press briefing on International Women’s Day. .
Free IP Won’t ‘Go Anywhere Close’ To Solving Problem 

Asked by a reporter about WHO’s COVID-19 Technology Access Pool (C-TAP) initiative, which has sought to involve pharma manufacturers into a patent pool – to share IP on COVID vaccines and other health technologies, Gilbert replied, “I have to confess I’m not familiar with that initiative, I’m sorry.”   

Gilbert added:  “I don’t think that just making IP freely available goes anywhere close to solving this problem, because it’s not just to the right to use the technology that’s needed, it’s the feedstocks, the  cell banks, the protocols, the assays, the standards, the reagents to do everything. 

“This requires a great deal of support from the first company that licensed the vaccine, and this can be done, but it can’t be done in a completely unlimited way. 

“So we have to recognize that it’s important we have many vaccines to use across the world: those that are licensed Now, those that are still in clinical trials and will be approaching licensure. We want to see a good range of vaccines, ideally using different technologies,  because that will increase the chance of having the largest number of doses available. 

“And then what we need is that once those vaccines are manufactured, licensed and distributed, the ones that are sitting in vaccine centers actually get used to protect people and we don’t let them sit there going past their expiry date.”

Gilbert also stressed that Oxford’s R&D philosophy has always been that:  “we wanted to have a vaccine for the world, and we wanted it to be manufactured and distributed widely. And we’re very pleased to see that that is being done with many sub-licenses to different manufacturers in different parts of the world – increasing the number of doses of the vaccine that we initiated development of, have now been made available across the world.” 

Novel mRNA Vaccine Technologies Require New Manufacturing Setup – Repurposed Facilities Not Good Enough 
Professor Sarah Gilbert, University of Oxford, co-founder of Vaccitech and the developer of the Oxford/AstraZeneca vaccine against COVID-19

Dr Özlem Türeci, co-founder and Chief Medical Officer of BioNTech, and the developer of the Pfizer-BioNTech COVID-19 vaccine, echoed Gilbert’s remarks saying:  “Yes, I can only echo what Sarah has pointed out, so it is a comprehensive solution and approach we need. 

“Also, in particular if it is about novel platforms and novel technologies for which even the setup of production facilities need to be expanded, and you cannot just repurpose existing facilities. So patents are one thing but there are so many other things we have to ensure.”

The Oxford/AstraZeneca’s developers have pledged to sell the vaccine on a not-for-profit basis for the duration of the pandemic.

Despite that, the company’s executives  have so far not explained why one of their key licensees, the Serum Institute of India, has been selling the Oxford/AstraZeneca vaccine to South Africa and Uganda at 2-3 times the price of the vaccine in Europe – where the European Union procured it for around US$ 3 a dose.

The Oxford/AstraZeneca vaccine is also the leading product being used in the initial rollout of vaccines by the WHO co-sponsored COVAX initiative – with the first doses of the COVAX rollout having reached the first three countries in Africa, Ghana, Cote d’Ivoire and Ghana, just last week. 

Pfizer/BioNTech, meanwhile, is marketing its  vaccine at for upwards of US$25 a dose, although Pfizer recently offered some 40 million doses of the cutting edge mRNA vaccine to the WHO co-sponsored COVAX initiative at cost. Uptake of the Pfizer vaccine in low and middle income countries is, however, limited by the vaccine’s cold-chain requirements storage at -70 C.  

The remarks coincided with a two-day Global C19 Vaccine Supply Chain & Manufacturing Summit, a closed door forum sponsored by the UK-based Chatham House, in which pharma leaders and global health experts and research institutes are meeting to discuss ways to unlock existing vaccine supply bottlenecks.

Image Credits: @WHO.