MANILA — The European Commission on Monday approved the use of the Pfizer-BioNTech’s COVID-19 vaccine, paving the way for European countries to join high-income countries such as the U.S. and U.K. in vaccinating their most at-risk populations.
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But for many lower-income countries, it remains unclear when their high-risk populations will be able to get their vaccinations. While the past year has seen unprecedented advances in science, it has also seen higher income countries hoarding vaccine doses from leading vaccine manufacturers, raising concerns on equity.
“It is so disappointing to see that we still fall on the same negativity: over-profiting, nationalistic hoarding of resources, so much [COVID] denial both from the public itself to, worse, from some ... top politicians (as in my country, Brazil),” Márcio Silveira da Fonseca, infectious diseases medical adviser for Médecins Sans Frontières’ Access Campaign, wrote to Devex in an email.
“High-income countries cannot have it both ways: Reject the [intellectual property waiver] proposal and do nothing for tech transfer.”— Ellen ‘t Hoen, lawyer and director, Medicines Law & Policy
“So when we start distributing vaccines, when we say health workers are a priority, does that mean only some health workers or is that all health workers? We have some questions to ask ourselves over the holiday period,” he said.
The deal with COVAX
A total of 12 high-income countries plus Hong Kong and the European Union have so far confirmed purchases of about 4 billion doses of COVID-19 vaccines. Meanwhile, 13 upper-middle-income and 8 lower-middle-income countries have secured 946 million doses and nearly 1.8 billion doses, respectively, based on data from Duke University's Global Health Innovation Center. Some of those deals are with vaccine candidates from Russia and China. It has not found evidence of direct vaccine deals made by low-income countries.
The data also includes 150 million doses of the Oxford-AstraZeneca vaccine for distribution in Latin American countries, excluding Brazil, as part of an agreement with biotech company mAbxience, which has a facility in Argentina. The agreement is financed mainly by the Carlos Slim Foundation.
For some of these high- and middle-income countries, their confirmed vaccine doses can inoculate their entire populations, and have millions more in excess. Canada, with its 38 million population, has enough to inoculate the entire country multiple times over, although there's still no guidance yet on the need for repeat vaccinations.
COVAX, the global vaccines initiative co-led by Gavi, the Vaccine Alliance, WHO, and the Coalition for Epidemic Preparedness Innovations, is meant to address the imbalance by equitably distributing COVID-19 vaccines and ensuring lower-income countries get a fair share.
Last week, amid concerns over COVAX’s ability to deliver on its mandate, partners announced that they had secured agreements ensuring access to nearly 2 billion doses of COVID-19 vaccines from four different vaccine manufacturers.
These include 170 million doses from AstraZeneca and the University of Oxford; 200 million doses of AstraZeneca-Oxford or Novavax vaccines via an agreement with the Serum Institute of India and the Bill & Melinda Gates Foundation, with an option for up to 900 million more doses; 500 million doses from Johnson & Johnson; and 200 million from Sanofi and GlaxoSmithKline.
The initial 2 billion doses target is meant to cover vaccination for high-risk populations, such as health care workers, the elderly, and those with underlying medical conditions globally. COVAX partners anticipate making the first deliveries of vaccines to all participating economies in the first quarter of 2021. It will need to raise a further $4.6 billion to procure 1.3 billion doses of COVID-19 vaccines through 2021.
COVAX also has the right of first refusal — the right to have the first transaction — to over 1 billion vaccine doses from manufacturers that have research and development partnership agreements with CEPI. A dose-sharing framework allowing high-income countries to share their bilaterally procured vaccines through the COVAX Facility for the benefit of LMICs was also launched last week, with Canada and France expressing its intentions to share excess doses.
The United States can also participate in the dose-sharing initiative, even if it has not signed up to COVAX, a Gavi spokesperson told Devex via email.
The aim for the framework is for the 92 LMICs and economies that have signed up to the COVAX Advance Market Commitment — funded largely by official development assistance — to receive “fully-subsidized vaccines in any case up to a target of 20% of their population, at which point further doses may be available on a cost-sharing basis,” the Gavi spokesperson said. Cost-sharing means these countries may be required to cover up to $2 per vaccine dose.
Among the framework’s principles for sharing doses is that they should be un-earmarked. While the framework doesn’t prevent higher-income countries from donating their excess vaccine doses directly to their countries’ of choice, the spokesperson said it’s “in everyone’s best interest that high-income countries’ excess supply is allocated equitably through the COVAX Facility.”
None of the manufacturers COVAX has announced agreements with have received regulatory approval to date, although some are expected to release efficacy results from late-stage clinical trials in the first quarter of 2021. Apart from availability, delivery of the vaccines will depend on regulatory approval, and countries’ vaccination readiness, such as having a national deployment plan and meeting cold chain requirements.
CEPI CEO Richard Hachett said they’re having ongoing discussions with Pfizer and BioNTech as well as Moderna. Apart from the European Union, Pfizer and BioNTech have received emergency use authorization or temporary authorization for their COVID-19 vaccine in several countries. Moderna received its emergency authorization in the U.S. this week.
A number of lower-income countries recognize the important role of COVAX, but argue what COVAX offers — vaccine doses to immunize at least 20% of countries’ populations — won’t be enough to cover the vast needs in their countries.
Regional institutions, such as the Africa Centres for Disease Control and Prevention, and the African Union Commission, for example, have said they are in discussions with vaccine manufacturers to discuss vaccine access for African countries. Africa CDC is also coordinating with finance institutions such as the World Bank and the African Export-Import Bank.
A critical question not often addressed however is access for internally displaced persons and refugees. Globally, more than 80 million have been forcibly displaced, according to the U.N. Refugee Agency. COVAX is setting aside 5% of total vaccine doses it secures to cover these populations, if they are not included in a country’s priority populations for vaccination.
“However, things are changing all the time. There are a record number of people displaced and security challenges will continue to evolve, and this could affect vaccine access for internally displaced people and refugees,” said Dr. Javed Ali, International Medical Corps director of emergency response.
The push against intellectual property
Since October, South Africa and India have pushed at WTO for the intellectual property rights on COVID-19 technologies to be waived, in order to unlock access to COVID-19 vaccines, medicines, and other products needed to control the pandemic.
But the proposal faces a steep battle in reaching consensus at the trade body. An alternative would be to put it to a vote, but that has never happened in WTO history.
“I don’t think it’s [the vote] going to happen,” Ellen ‘t Hoen, lawyer and director of research group Medicines Law & Policy, told Devex. “But … high-income countries cannot have it both ways: Reject the [intellectual property waiver] proposal and do nothing for tech transfer.”
High-income countries also cannot refer to WHO’s COVID-19 Technology Access Pool — which calls for the voluntary sharing of knowledge and data on COVID-19-related products — and “do nothing to make it work,” she said.
But outside the WTO discussions, she anticipates some movement happening on voluntary licensing and tech transfers, with strong supporters of intellectual property “singing a very different song,” ‘t Hoen said.
A number of pharmaceutical companies and high-income countries have pushed back on the proposal, saying it will only stifle innovation and would send a bad precedent for future crises. They argued the real barrier to access is lack of production capacity, and not intellectual property.
The EU’s latest statement on the waiver however references the TRIPS agreement and its flexibilities to address licensing issues with COVID-19 technologies, and the union’s readiness to “discuss ways of overcoming” countries’ challenges in implementing those flexibilities.
The CEO at CureVac, whose COVID-19 vaccine candidate has recently entered late-stage clinical trials, meanwhile, has called for greater international cooperation and suspension of patents amid the pandemic.