Access Advocates Urge 11th Hour WTO Action on COVID IP Waiver – COVAX Strikes World Bank Deal on Vaccine Finance
New WTO Director General Ngozi Okonjo-Iweala, has urged WTO members to find a way to compromise, but rich and poor countries remain an at impasse.

Vaccine access advocates issued increasingly desperate, last minute calls upon the World Trade Organization to take action over a stalled initiative to impose a temporary waiver on intellectual property for COVID medicines, tests and vaccines – even as the initiative appeared doomed to a stalemate for the rest of the summer. 

Ahead of the opening of Tuesday’s two-day meeting of the WTO General Council, Médecins Sans Frontières urged the European Union (EU), Norway, the UK, and Switzerland “to stop stalling the landmark proposal to waive intellectual property (IP) on lifesaving COVID-19 medical tools at the WTO, and join forces with more than 100 countries supporting it by openly engaging in formal negotiations to expedite the consensus. 

“Since the proposal was first tabled nearly 10 months ago, the pandemic has worsened and increasingly hit many countries across Africa, Latin America and Asia, with the disease having killed officially more than 4 million people globally,” MSF noted, referring to a proposal by India and South Africa for a blanket waiver on WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), for COVID-related IP, which supporters say would lower prices faster and stimulate local vaccine and medicines production. 

African COVID surge due to lack of access to medicines and vaccines 

Health workers in Cape Town, getting vaccinated against COVID-19 in March 2021. On a continent beset with supply shortages, South Africa is one of the few African countries to have been able to continue mass COVID vaccinations at scale over the past weeks and months.

 African MSF pointed to the worrisome rise in COVID-related deaths in Africa – linked to the low levels of vaccine access which have seen only about 1.5% of the population vaccinated – in comparison to some 50-60% in many high-income countries. 

“As many countries in Africa right now are reporting a high number of deaths due to the spread of new and existing variants of COVID-19, these governments are in dire need of vaccines, diagnostics, oxygen and other treatments to help save lives of critically ill patients,” said Dr Tom Ellman, director of MSF’s Southern Africa Medical Unit. “While the World Health Organization recommends two newer therapeutics for patients with severe COVID-19, medical practitioners and their patients in many low- and middle-income countries cannot access them due to monopolies, limited supply and high prices. It is outrageous to see countries blocking the TRIPS Waiver that is desperately needed as an important tool to remove legal barriers and allow production to be scaled up by multiple manufacturers for critical COVID-19 drugs, diagnostics and vaccines.”

European countries & industry backed voluntary measures 

Ursula von der Leyen, President of the European Commission, at a Global Health Summit event in late May. The EU has supported broader vaccine access, in prinicple, but critics say it falls down on practices that would more rapidly open the doors to production in low- and middle-income countries.

European countries have touted increased pharma collaborations – including a recently announced mRNA vaccine production hub in South Africa, as examples of how voluntary measures will be more effective than a blanket waiver.   Pharma voices have also warned that a wide-open WTO IP waiver on complex and sensitive biological vaccine manufacturing processes would open the floodgates to shadowy producers that could suck up critical, but scarce, inputs – without reliably expanding supplies.  And, they point to the fact that global production will scale up rapidly – so that the real solution is for rich countries to stop hoarding current supplies until that can happen. 

But MSF said donations and other voluntary measures have failed to work, pointing out that so far Pfizer and Moderna, the manufacturers of the two most efficacious, mRNA vaccines, have so far allocated only 11% and 0.3% of their production to low- and middle-income countries (LMICs).  And the problem is not only with respect to vaccines, MSF points out, citing the recently WHO-approved COVID antibody cocktail treatments, tocilizumab and sarilumab, as examples.

Sarilumab, known by its brand name Regeneron, costs as much as US $1830 per dose, MSF noted. Roche, the Swiss company that produces tocilizumab, has said it will not enforce its patents in some countries. But that does not go far enough to really reduce prices and expand supplies, MSF charged. 

“Two new potential COVID-19 therapeutics, casivirimab and imdevimab, are also patented by Regeneron and are being sold as a cocktail at a dose price of $US 820 in India, $US 2,000 in Germany and $US 2,100 in the US. These high medicine prices and monopolistic actions are barriers to global access,” said the MSF statement.

“At a moment when we are in race against time to save lives and control the spread of unchecked transmission and development of new dangerous variants, pharmaceutical corporation’s business-as-usual approach is intolerable. With potentially promising treatments in the pipeline, opposing countries must stop filibustering the waiver proposal and support it to cover not just vaccines, but also treatments, diagnostics and other health technologies,” said Ellman. 

WHO Director General Dr Tedros Adhanom Ghebreyesus last week issued similar pleas and warnings, saying that the world simply lacks the “political will” to end the pandemic – even though it has the means.

But on the eve of the WTO General Council meeting of trade ministers, chances for any sort of breakthrough appeared increasingly slim.  While waiver proponents say that they have over 100 backers for their proposal, most WTO decisions are taken by consensus, and so opposition by even one of the WTOs 164 members would perpetuate the impasse.  Once the General Council breaks, negotiations would not likely resume until mid-September at the earliest – although WTO Director General Ngozi Okonjo-Iweala last week urged WTO members to shorten their holidays in order to come to some sort of agreement, in light of the urgency of the pandemic.

COVAX facility announces new World Bank loan arrangement for vaccine purchases  

COVAX-led vaccine deliveries, launched in February and then nearly halted in April, after India experienced a COVID surge, leading to the diversion of supplies from the Serum Institute of India domestic needs.

Meanwhile, the beleaguered COVAX global vaccine facility, whose ambitious COVID vaccine distribution plan to low-income countries faltered over vaccine hoarding and supply shortages this spring, has made a new deal with the World Bank to finance its advance vaccine purchases. 

The new finance mechanism, announced jointly by Gavi, The Vaccine Alliance and The World Bank, should help ease constraints faced by COVAX in competing for the future purchase of available vaccine doses on the open market – making it less dependent on rich country donations to seal deals for large vaccine pre-purchases. 

That reliance upon rich country largesse and donations, which were not always provided in a timely manner proved to be a key stumbling block in the COVAX facility’s ability to compete and secure large quantities of vaccine doses from multiple suppliers in the initial phases of COVID vaccine rollout, critics told Health Policy Watch in a recent story on COVAX’s shortcomings. 

Gavi announcement thin on details of new arrangements

Gavi CEO Seth Berkley

But Monday’s announcement was thin on details of who would, in fact, be taking out the loans for the vaccine purchases – COVAX or the countries themselves – as well as timeframe and terms for repayment. 

The new arrangement will “accelerate COVID-19 vaccine supply for developing countries through a new financing mechanism that builds on Gavi’s newly designed AMC (advanced marketing commitment) cost-sharing arrangement,” said the Gavi/World Bank press release. “This allows AMC countries to purchase doses beyond the fully donor-subsidized doses they are already receiving from COVAX.”

Asked by Health Policy Watch for further details on the new financing mechanism, GAVI did not immediately reply. 

Some 92 low- and middle-income countries participate in Gavi’s longstanding AMC scheme, which offers  a wide range of vaccines for childhood diseases at free or concessionary prices – and more recently COVID vaccines. 

Bolstered by the new finance, COVAX says it will be able to make available up to 430 million additional COVID vaccine doses, or enough to fully vaccinate 250 million people, for delivery between late 2021 and mid-2022. 

Adjusted 2021 COVAX supply forecast remains highly ambitious – even after setbacks 

In light of the supply problems already seen, COVAX delivery goals for 2021 have been dialed back significantly – from the 1.8 billion doses that COVAX had initially aimed to provide.  

The global supply forecast of the COVAX Facility for 2021 and 2022, as of 6 July.

The latest forecasts, issued on 23 June, and 6 July suggest that the facility still aims by the end of December to have some 1.8 milion vaccine doses available, and deliver some 1.1 to 1.5 billion.  

However, even that remains a highly ambitious goal – insofar as only 138 million COVID vaccine doses had been delivered globally by the COVAX facility, as of 23 July.  

According to the new Gavi-World Bank finance arrangements, countries with “approved World Bank vaccine projects” can then confirm the purchase of additional doses through COVAX and the Gavi AMC facility, benefitting from a wider choice of vaccines as well as delivery windows. 

“On receiving a request from the country, the World Bank will provide COVAX a payment confirmation, allowing COVAX to make advance purchases of large amounts of vaccine doses with manufacturers at competitive prices.

“There will be several supply offerings where countries will have the opportunity to select and commit to procuring specific vaccines that align with their preferences,” said the press statement by Gavi and The World Bank. 

“Accessing vaccines remains the single greatest challenge that developing countries face in protecting their people from the health, social, and economic impacts of the COVID-19 pandemic,” said World Bank Group President David Malpass. “This mechanism will enable new supplies and allow countries to speed up the purchase of vaccines. It will also provide transparency about vaccine availability, prices, and delivery schedules. This is crucial information as governments implement their vaccination plans.”

Supporters of the COVAX facility have long affirmed that the model is solid – but more predictable finance is needed to allow the facility to compete for vaccines more aggressively in the marketplace. 

Civil society advocates have charged that the more fundamental problem with COVAX remains the charity-based model that it represents – anchored in donations of money or vaccines by rich countries – rather than support for the wider production of vaccines in LMICs themselves. 

COVAX is co-led by Gavi, the World Health Organization (WHO) and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) – all working in partnership with UNICEF and the PAHO Revolving Fund to distribute vaccines and support vaccine campaigns on the ground in countries.  

Image Credits: Felix Dlangamandla, DGTresor , Western Cape government, European Commission, Gavi , WHO.

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