Hi,

All in a week’s time: a vaccine has shown high levels of efficacy against COVID-19; promised deliveries for vaccines appear slimmer; and countries continue to block efforts to liberate vaccine manufacturing capacities at WTO.

It is as if the response to COVID-19 is being pulled in diametrically opposing directions. The walls of opacity that surround crucial decisions on the response to the pandemic are surely crumbling, just not fast enough to staunch the spread of SARS-CoV-2 infections.

This week we bring you two stories - one that looks at how the current stock of vaccines is expected to find its way to countries (COVAX forecast), and second, what countries are doing or not doing to increase the flow of vaccines (TRIPS proposal WTO). These collectively capture global health Geneva in the past few days.

In bleak times, a ray of hope,  like the TRIPS waiver proposal at WTO, looks more radiant than it may be. We admit that it has been difficult to get a reading on how the positions of countries might have changed, or not at all, in their opposition to the TRIPS waiver discussions at WTO this week. But cracks may be appearing, on account of the limitations to prolonged inconsistencies as we pointed out earlier this week. Read more on this, in our trade and health update.

In our other story of the week, we look closely at Gavi’s forecast for the supplies of COVID-19 vaccines - what it tells us, and what it does not.

We also want to understand why regulatory approvals for some of the vaccine candidates are slow. Are there only technical reasons? Who controls the narratives around certain vaccines and what does it reveal about global health? Write to us.

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See you next week.

Best,

Priti

Write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva

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1. Story of the week

Reading the COVAX vaccine supply forecast

Even as Geneva-based health organizations announced forecasts for the supply of COVID-19 vaccines, countries in some parts of the world fear that their promised deliveries for vaccines were now being reprioritized by some manufacturers affiliated with the COVAX Facility. There is not enough clarity yet on how many countries will be affected in the short term.

This story parses through the official statements made by health agencies and contrasts it with publicly available information which suggest that bilateral deals between vaccines manufacturers and countries have begun to have an impact on vaccine deliveries for the COVAX facility as many had predicted.

“A number of countries are expressing fears that deliveries slated for the COVAX Facility have now been reprioritised for high-value bilateral deals,” a Geneva-based trade official who had spoken with a number of developing countries, told Geneva Health Files on the condition of anonymity.

Image credit: Pexels.com

Officials in Geneva indicated this week, that countries awaiting COVID-19 vaccines from the COVAX Facility might have to wait until late February or even early March for the first vaccines to reach their most vulnerable populations. This is conditional upon a number of caveats including tying up supply agreements with manufacturers in time, putting in place formalities for liabilities and indemnification, getting required regulatory approvals, among others.

Even after this long wait, it is not clear when the actual roll-out of vaccines will begin. Authorities including officials from WHO and Gavi – The Vaccine Alliance, said that the indicative allocations discussed with participating countries in the COVAX Facility are not binding and subject to a number of caveats. WHO has said that the final allocations of vaccine doses will be published in due course.

It also appears that the volumes of doses from directly from AstraZeneca and those vaccines from AstraZeneca sourced from the Serum Institute of India, have been revised downwards for the first half of 2021, allegedly on account of delays due to regulatory approvals, top officials of Gavi said. A major portion of the vaccine doses from the COVAX Facility are expected to arrive in the second half of 2021.

In a briefing to discuss the interim forecast of the roll out of COVID-19 vaccines, officials laid out plans for how and where COVID-19 vaccines will be rolled out in the coming months subject to caveats. In what was described as indicative allocations for countries, authorities explained pricing, logistical and other matters in the context of the roll-out of vaccines. 

The distribution forecast lays out the “early projected availability” of doses of the Pfizer/BioNTech vaccine and the AstraZeneca/Oxford vaccine candidate in first six months of 2021. Gavi had signed an advance purchase agreement with Pfizer/BioNTech, which was followed by WHO’s emergency use authorization for the vaccine. This is the first COVID-19 vaccine which got WHO’s approval late last year.

Speaking at the briefing, WHO official, Ann Lindstrand, EPI Coordinator at the organization, pointed out that this was the first time that a vaccine was being made available within such a short period of time from the date of the emergency use authorization.

Of the 190 countries with varying degrees of association with the COVAX Facility, 145 are expected to receive these early doses of vaccines. The remaining countries have either exercised their rights to opt-out, have not submitted vaccine requests, or have not yet been allocated doses, Gavi explained.

The First Vaccine Doses From COVAX: When and How Much

According to the interim forecast, the total doses aim to cover “on average, 3.3% of the total population of the 145 participants receiving doses from at least one manufacturer” in the first few months. Gavi says that this is adequate to protect the most vulnerable groups such as health care workers.

According to Gavi, “This indicative distribution is intended to provide interim guidance to Facility participants – offering a planning scenario to enable preparations for the final allocation of the number of doses each participant will receive in the first rounds of vaccine distribution. It is therefore non-binding and may be subject to change, due to the caveats outlined below.”

The “indicative distribution” lists 240 million doses of the AstraZeneca/Oxford vaccine, licensed to Serum Institute of India (SII) [AZ/SII] and 96 million doses of the AstraZeneca/Oxford vaccine [AZ] for the first two quarters of 2021. (Officials said that for the AZ vaccines, the 96 million of doses was lower than the expected 153 million doses for this period on account of pending regulatory approvals.)

Specifically, for AZ/SII, the indicative distribution doses translate into 35-40% available in the first quarter and 60-65% available in the second quarter. For AZ, of the 170 million doses, 15% is anticipated to be available in the first quarter and 42% is expected to be available in the second quarter. Further supply is planned for the second half of the year, according to the interim forecast.

Gavi also lists the “exceptional first round allocation” of 1.2 million doses of the WHO Emergency Use Listing (EUL)-approved Pfizer-BioNTech vaccine for the first quarter of 2021. Additional doses of the Pfizer vaccine will arrive after this period. These doses are part of the advance purchase agreement between Gavi and Pfizer-BioNTech for up to 40 million doses in 2021.

(Three WHO Emergency Use Listing (EUL) evaluations are currently underway in relation to the AstraZeneca/Oxford vaccine: for doses manufactured by AstraZeneca, SK Bioscience, and Serum institute of India.)

On regulatory approval, Gavi adds that “The actual allocation will only be announced once a product is granted the WHO EUL, and this indicative distribution information does not imply or pre-suppose that this vaccine will be granted WHO EUL.”

The final allocation of these doses (from AZ and AZ-SII) is subject to the regulatory approvals and “the current estimates of supply”. Further the process will also need the validation of the Independent Allocation of Vaccine Group (IAVG).

Further, that “the exact delivery after allocation will depend on the sequence of countries in the shipment plan, the time taken to place the purchase order, legal / regulatory obligations, as well as the supplier’s lead time and related logistics,” Gavi has said.

On supply concerns, (which in recent days have plagued European Union prompting the use of export restrictions), Gavi says, “It is important to underscore that the indicative distribution is based on current communication of estimated availability from manufacturers. In this regard, it is likely the distribution may need to be adjusted in light of circumstances that are difficult to anticipate and variables that are constantly evolving….The indicative distribution takes into account current estimation of supply volumes. The supply volume may vary due to manufacturing/and or operational constraints, and this will have an impact on the doses that will be allocated to countries.”

(It is also understood that a small reduction in doses, also contribute to building up of the Humanitarian and Contingency Buffer.)

Gavi also makes it clear no doses will be allocated in the final allocation if a participant is deemed not ready (for AMC countries).

On the distribution of Pfizer vaccines in the first quarter of 2021, Gavi said that “As a result, an exceptional process of distribution was undertaken to ensure maximum public health benefit from the smaller volume of doses..” (It has clarified that all future allocation rounds will follow the standard Facility approach.)

“Given the limited doses, the complexities related to rolling-out a vaccine requiring ultra-cold chain, and to ensure maximum public health impact, a decision was made to limit the number of countries for first deliveries of the Pfizer-BioNTech vaccine in order to enable successful distribution and delivery,” Gavi says. A technical assessment was made to review country readiness including by UNICEF, WHO and Gavi.

In a related press statement issued this week, MSF said:

“MSF calls on vaccine manufacturers to ensure that priority is given to those countries that are in urgent need of protecting their healthcare staff,” says Isabelle Defourny, MSF Director of Operations. “MSF stands ready to provide logistical support to high priority countries that were denied access to the Pfizer/BioNTech vaccine through COVAX because of their limited cold chain management capacity.”

Ravaged by new strain, southern Africa must get COVID-19 vaccines: MSF

How Countries Were Chosen:

Countries who are slated to receive the first doses were selected on the basis of some criteria including readiness, whether they had already started vaccinations (those who had have not been included in this “first exceptional allocation round” for the Pfizer vaccines), pricing preferences (for self-financing countries), and on the assessment of risk of health care worker exposure. (While there is “no direct measure of that exposure, a combination of indicators/data were used as a proxy, including mortality rates over the last 28 days,” Gavi explains)

On The Pricing Of Vaccine Doses Under The COVAX Facility

Responding to a number of questions on the pricing of the vaccines acquired under the COVAX facility, Seth Berkley, Gavi’s CEO said that the pricing information will be published in due course.

“We are not making those prices available initially till the long-term supply contracts are published,” Berkley said.

He also suggested that costs of each dose of vaccines is also determined by where the manufacturer was located (“fixed costs of each facility”). Therefore, the same vaccine candidate can have different prices based on where it is produced.

UNICEF top officials said that contracts will be published after consent from manufacturers. Gian Gandhi, from UNICEF’s Supply Division said that the organization has been publishing contracts for the last several years.

COVAX Vs BILATERAL DEALS

There are a number of factors contributing to uncertainties on vaccines for the facility that aims for equitable access for all countries. Apart from fears that new European Union export restrictions could interfere with the access to vaccines in other parts of the world, a rash of bilateral deals between COVAX-affiliated manufacturers and desperate countries are also adding to scarcity of vaccines for the developing world.  

Leena Menghaney, MSF India

Recent bilateral deals between the Serum Institute of India and some countries in Africa and elsewhere, show that some countries might have potentially paid higher prices for vaccines. (South Africa reportedly has paid a higher price for AZ/SII vaccines than the EU)

But experts also point out, in the absence of clarity on the price agreed by COVAX with vaccine manufacturers, it was hard for countries to judge if they had indeed overpaid for vaccine doses in their bilateral deals. “This also shows a lack of confidence by countries in the COVAX Facility,” an expert who works with developing countries in Geneva said. Uganda, has defended the price it has paid in its bilateral deal which is reportedly 20% more than what South Africa has paid.

It also emerged during the week that sixteen African countries are part of an African Union plan to secure vaccines, according to the Africa Centres for Disease Control and Prevention (CDC). The AU has already secured 670 million doses for countries. (In addition, WHO Africa director Matshidiso Moeti, has said that the COVAX facility aims to help secure vaccines for 20% of Africans, which will mean about 600 million doses.)

Notwithstanding complex production challenges that some manufacturers face which are adding to delays in the supply chains, the vaccines pool is further being soaked dry by also   those countries who have already acquired enough doses for their populations. Developed countries including Canada and New Zealand have also been criticised for drawing on vaccines from the COVAX Facility.  

“We are disappointed to hear that Canada, New Zealand and Singapore will draw on a supply of COVID-19 vaccines from the COVAX pool. Could these delegations indicate whether this is correct?”

South Africa raised this question in its statement at the TRIPS Council discussions at WTO this week. (See story below)

The efficacy of vaccines in the face of rising mutations in the SAR-CoV-2 virus is also likely to worsen the access challenges in the COVID-19 pandemic. Undoubtedly, health agencies are in an unenviable place under pressure from manufacturers, and countries driven by vaccine nationalism. In these uncertain times, surely countries would appreciate greater transparency from these health agencies.

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2. The Trade & Health Update

Cracks In The Opposition To The Waiver Proposal?

THE TRIPS WAIVER PROPOSAL: WTO TRIPS Council Informal Meeting

Vaccine production woes and internal EU squabbles on accessing vaccines might have opened up a new frontier that could help proponents of the TRIPS waiver proposal.

Although some countries continued to oppose the proposal and refused to engage in text-based discussions, diplomatic sources in Geneva say that there has been a perceptible shift in the position of many countries. Less opposition may not mean more support, but it opens up spaces for discussions particularly at the bilateral level.  

Countries including Canada, the United Kingdom, Switzerland and Japan, continued to oppose the waiver proposal during the informal TRIPS Council meeting on February 4th. Members including the EU and the U.S. did not want to proceed towards text-based discussions, sources said.

Egypt, Nigeria, Jamaica on behalf of the ACP Group, Pakistan, Tanzania on behalf of the African Group, Zimbabwe, India, Kenya, Venezuela and Sri Lanka spoke in favor of South Africa's suggestion to discuss "text" for the waiver proposal.  

Some believe that the continuing deliberations at the TRIPS Council without agreeing to discuss the proposal in concrete steps is a stalling tactic of some developed countries. However, as infections and deaths from COVID-19 continue, and variants of SARS-CoV-2 proliferate raising concerns on the efficacy of new vaccines, these countries have been forced to consider the political implications of their decisions. This might contribute to their willingness to engage in finding potential agreement in the context of the proposal, diplomatic sources in Geneva said on the condition of anonymity.

“We need to close the evidentiary loop and get down to textual negotiations that can further refine the waiver proposal that we tabled. We cannot continue to engage in endless discussions while in the real-world millions of lives are lost to the coronavirus pandemic,” South Africa said in a statement.

It is understood that a number of countries questioned and criticised the EU on new export restrictions.

In its statement, South Africa said: (excerpts)

“…Those countries that continue to oppose the waiver most vociferously are indeed the ones that have secretly bought up the available production and continue to collude with pharmaceutical companies under the veil so secrecy. We have now seen the chicks come home to roost, where the veil of secrecy has been lifted and one Member has now taken measures to restrict exports from its territory. Yet this Member is a proponent of free trade and the non-application of export restrictions.

This very Member has posed pointed questions to the proponents yet does everything it can to undermine global solutions being sort, even in light of the fact that it proclaims itself to be a major donor to such global initiatives. Secrecy is at the heart of this matter, and even under these dire circumstances where the lives of millions of citizens of this Member are at risk and vaccine supplies having been reprioritised away from this Member, it still refuses to face the reality of the situation.

The EU has gone down a slippery slope, the consequence of its export authorisation scheme, which is de facto an export restriction, will have manifold implications for all of us and may launch an avalanche of further trade restrictive measures by other Members.

The EU export control regime on COVID-19 vaccine is supposed to be implemented on objective, transparent, and proportionate grounds, can the EU give assurances to that effect? Is the authorisation process rule-based or influenced by diplomatic considerations and therefore arbitrary?”

EU responded to these criticisms by laying out the scope and duration of these restriction measures. The EU reportedly acknowledged facing "significant difficulties" with respect to accessing vaccines. It said that the decision to resort to export restrictions was in response to a possible breach of contracts signed with the EU. It said that doses initially targeted for the EU may have been exported to third countries. In order to prevent such violation, the Commission decided that all vaccine manufacturers should declare exports to third countries. It explained that these obligations target vaccine manufacturers, and applicable until end of March 2021. The EU assured members that these measures will be proportionate and will not slow down the vaccine trade between the EU and third countries, a source said.  

Production concerns might give way to some scepticism towards manufacturing capacities of developing countries. Opposing countries have long argued that complex drugs such as mRNA vaccines will need technology transfer, for example. Therefore a waiver may not solve these challenges, some countries have said.

Proponents also furnished information highlighting manufacturing capabilities in the developing world. “Out of the 154 prequalified vaccines under WHO's PQ program 72 vaccines are produced by vaccine manufacturers from developing countries. These vaccines are originating from various developing country manufacturers including from India, China, Brazil, Cuba, Thailand, Senegal and Indonesia. Similarly, LMIC countries have a substantial share in prequalified finished pharmaceutical products, active pharmaceutical ingredients and vaccines”, South Africa said in a statement.

“There seems to be some interest in exploring spare capacities for boosting manufacturing capacities. Some of the bilateral discussions could focus on finding immediate solutions,” one diplomatic source said.

Sources also indicated that the US said it was open to “working together with members to better understand the facts" where TRIPS obligations on patents, copyright, industrial designs, or trade secrets might have led to constraints on manufacturing capacity.

This is being read as a shift in positions of some of these countries from hard-core denial on intellectual property being a barrier to a tone which is more conciliatory. Some members are beginning to explore whether there are barriers to access posed by intellectual property protection, one official said. A greater push for the use of TRIPS flexibilities by European countries is also a distinct change, a diplomatic source pointed out.

EMERGING SIGNS OF SUPPORT?

Dr Anthony S Fauci this week called for supplementing the abilities of countries to produce vaccines in a way that countries can have the productive capacities so that they could manufacture vaccines with the cooperation from pharma companies for the relaxation of patents. He drew parallels to the interventions by rich countries during the HIV crisis.

Movement In Brussels?A Geneva-based trade official confirmed that efforts were being made to meet with EU member states individually.

Nicoletta Dentico, Head of the Global Health Programme at Society for International Development (SID), told Geneva Health Files that several members of European Parliament are pushing to discuss the TRIPS waiver proposal. There are efforts being made to get a resolution so that the European Commission could consider it.

There have been efforts to get the Italian Presidency of the G20 to extend support to the TRIPS waiver proposal. Both India and South Africa, proponents of the proposal are members of the G20. Civil society groups are advocating the Italian presidency at the G20 to support the proposal, she added.

WHAT NEXT?

Next TRIPS Council formal meeting will be on 23rd February to work on a draft report for the  General Council that meets in early March. Countries are expected to meet in smaller groups for bilateral discussions in the coming days.

The resistance to the TRIPS waiver proposal even in the midst of a pandemic continues to exist in many quarters not just at free-market media establishments. Some academics have called this a guerrilla war against IP rules.

See this excerpt from a recent Politico story:

Behind the spat at the WTO, a larger question looms: Is this an attempt to permanently override aspects of intellectual property rights that some countries disagree with? 

“You can essentially see it as a play by two countries, India and South Africa, who never really liked the current intellectual property rights rules of the WTO,” said Simon Evenett, an economics professor at St. Gallen University in Switzerland. “I see it in a broader 25-year-long context of this sort of guerilla war against these rules.”

….“Almost every major pharmaceutical exporter except India has objected to this,” Evenett said. “I don’t see that proposal going ahead, unless circumstances dramatically change.

Europe hints at patent grab from Big Pharma, Politico

It is very likely that the current discussions at the TRIPS Council on the waiver proposal will eventually seek to move towards attempts to discuss broader rules on intellectual property, sources said.

The demand for a global solution is evident during this pandemic.

In its statement, South Africa said:

“These provisions were never designed to deal with pandemics that exist at the same time in all countries in the world. In these circumstances individual actions will not be effective and would have to be complied on a case- by-case individual basis. Such individual actions may nonetheless impede global solutions such as envisage by the TRIPS waiver proposal. Further, the flexibilities as they exist need further clarification to help us to react to pandemics such as COVID-19, clarification is required across the board ranging from copyright, to industrial designs, patents and undisclosed information…”

The stage is set.

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