LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products.

That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX.

For COVAX as a whole, in which 190 countries are pooling their purchasing power, there is now guaranteed access to a portion of the initial wave of commercial vaccines production, to be followed by further deliveries as manufacturing is scaled. All 190 are promised deliveries in the first half of 2021, with the proviso that the rollout is subject to regulatory approvals.

Of the 2 billion doses expected to be available next year, 1.3 billion will be donated to the world’s 92 poorest countries, with the aim of immunizing 20% of their populations by the end of 2021.

GAVI announced on Dec. 18 that it has signed an advance purchase agreement with Astrazeneca plc for 170 million doses of its AZD-1222 vaccine and inked a deal with Johnson & Johnson Inc. for 500 million doses of JNJ-78436735.

These deals are in addition to an existing agreement with the Serum Institute of India for 200 million doses of either AZD1222 or Novavax Inc.’s NVX-coV2373, both of which Serum Institute is manufacturing, with options for 900 million doses more.

COVAX also has signed a statement of intent for 200 million doses of Sanofi SA/Glaxosmithkline plc’s now delayed adjuvanted recombinant protein subunit vaccine.

“From the beginning of the pandemic, we knew we would need a vaccine to end it, but we also knew without concerted action, low income countries would miss out on vaccines once they arrived,” said Tedros Adhanom Ghebreyesus, director general of the World Health Organization (WHO). “Now images of people receiving vaccines are giving us hope, but it must be hope for all, not for some.” he said.

By combining the purchasing power of 190 countries – a list that does not include the U.S. – COVAX now has access to the biggest portfolio of COVID-19 vaccines, minimizing risk of failures in clinical trials, and striking a balance across products with different characteristics.

“The main message is that our goal of equitable access to vaccines is alive and well,” said Seth Berkley, CEO of Gavi. “We still need more doses, and we still need more money, but we have a pathway to securing two billion doses.”

Supplies needed, too

Of the 92 countries that are eligible for donated vaccines, 85 have submitted requests for supplies. Initially, doses will be allocated pro rata according to the size of the population, and will be administered according to principles set out by WHO, which call for health and social care workers to be immunized first, followed by the elderly and other vulnerable groups.

“The whole goal of COVAX is to try and vaccinate people around the world at the same time. But knowing supplies are limited, we can’t do mass vaccination, so the aim is first to prevent deaths, then to protect health care systems, and next to enable countries to start opening up their economies,” said Soumya Swaminathan, WHO chief scientist.

The third arm of the COVAX alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), has funded clinical trials and process development for ten COVID-19 vaccines, and through these R&D partnerships currently has rights to a further one billion doses – depending on how manufacturing development pans out.

However, one of the vaccines that CEPI backed, the University of Queensland, Australia - CSL Ltd. product has been axed after volunteers generated antibodies against an HIV protein fragment used to stabilize the product.

Securing the right of first refusal to successful vaccines is a founding principle of CEPI, said Richard Hatchett, CEO. “Science has given us the tools to fight the pandemic, but equitable access is what will enable us to win,” he said.

COVAX also is in negotiations with Pfizer Inc./Biontech SE and Moderna Inc. to secure supplies of their approved/about to be approved mRNA vaccines, said Hatchett. “We hope to be able to reach agreements, but they are not ready to be announced,” he said.   

To date, COVAX has raised $2.4 billion, of which $2 billion will pay for the vaccine donations in 2021. The organization currently estimates it needs to raise an additional $6.8 billion in 2021, of which $800 million is for research and development, $4.6 billion for vaccine donations and $1.4 billion to support distribution and administration.

Surplus vaccine donations

A number of the countries that have put their purchasing heft behind COVAX, also have made national advance purchase agreements for various vaccines, which if they all translate through to vaccine deliveries will mean they have spare doses. That includes the EU, which has negotiated agreements on behalf of all member states.

COVAX on Dec. 18 set out principles for dose sharing, providing a framework for higher income economies to donate any surplus vaccines secured via bilateral deals.

Speaking at a briefing held to discuss the latest COVAX developments, Canada’s international development minister, Katrina Gould, confirmed that if Canada has surpluses of the vaccines it has agreed to buy, it will make donations.

“We need to vaccinate high risk [populations] as soon as possible,” Gould said. “All participating countries have the same vision of protecting everyone, everywhere.”

According to an analysis published last month by Duke University’s Global Health Innovation Center, Canada has secured 214 million doses of seven COVID-19 vaccines, enough to administer a single dose to the entire population 5.5 times, if all of the products are approved.

As to timing of donations, Gould said, “Last night the prime minister [Justin Trudeau] said Canada would donate any excess capacity, but we have to take it one day at a time. There is only one vaccine approved and just starting to arrive.”