COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced the signing of an advance purchase agreement with Pfizer for up to 40 million doses of the Pfizer-BioNTech vaccine candidate, which has already received WHO emergency use listing. Rollout will commence with the successful negotiation and execution of supply agreements.

In further support of its mission to expedite early availability of vaccines to lower-income countries and help bring a rapid end to the acute stage of the COVID-19 pandemic, COVAX also confirmed today that it will exercise an option – via an existing agreement with Serum Institute of India (SII) – to receive its first 100 million doses of the AstraZeneca/Oxford University-developed vaccine manufactured by SII.

Of these first 100 million doses, the majority are earmarked for delivery in the first quarter of the year, pending WHO Emergency Use Listing. The WHO review process, which is currently underway, follows approval for restricted use in emergency situations by the Drugs Controller General of India earlier this month, and is a critical aspect of ensuring that any vaccine procured through COVAX is fully quality assured for international use. According to the latest WHO update, a decision on this vaccine candidate is anticipated by the middle of February.  

COVAX also anticipates that, via an existing agreement with AstraZeneca, at least 50 million further doses of the AstraZeneca/Oxford vaccine will be available for delivery to COVAX participants in Q1 2021, pending emergency use listing by WHO of the COVAX-specific manufacturing network for these doses. A decision on this candidate is also anticipated by WHO in February.

“Today marks another milestone for COVAX: pending regulatory approval for the AstraZeneca/Oxford candidate and pending the successful conclusion of the supply agreement for the Pfizer-BioNTech vaccine, we anticipate being able to begin deliveries of life-saving COVID-19 vaccines by the end of February. This is not just significant for COVAX, it is a major step forward for equitable access to vaccines, and an essential part of the global effort to beat this pandemic. We will only be safe anywhere if we are safe everywhere,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads COVAX procurement and delivery.

Preparations, led by WHO, UNICEF and Gavi, are already well under way for COVAX to deliver vaccines to economies eligible for support via the COVAX AMC, with Gavi making US$ 150 million available from its core funding as initial, catalytic support for preparedness and delivery.

“The urgent and equitable rollout of vaccines is not just a moral imperative, it’s also a health security, strategic and economic imperative,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization. “This agreement with Pfizer will help to enable COVAX to save lives, stabilize health systems and drive the global economic recovery.”

Building on the work of the past months supporting country readiness efforts, a “Country Readiness Portal” will be launched by WHO this month, which will allow AMC participants to submit final national deployment and vaccination plans (NDVPs). This is a vital step before allocations can be made, to ensure that delivered doses are able to be effectively deployed and to identify where, if necessary, further support is needed.

“These purchase agreements open the door for these lifesaving vaccines to become available to people in the most vulnerable countries,” said UNICEF Executive Director Henrietta Fore. “But at the same time we are securing vaccines we must also ensure that countries are ready to receive them, deploy them, and build trust in them.”

The COVAX Facility intends to provide all 190 participating economies with an indicative allocation of doses by the end of this month. This indicative allocation will provide interim guidance to participants – offering a minimum 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.

Supply update

COVAX now has agreements in place to access just over two billion doses of several promising vaccine candidates. Negotiations continue for further doses to be secured through existing R&D agreements by COVAX co-lead the Coalition for Epidemic Preparedness Innovations (CEPI), through evaluations of new products with promising results and through contributions from donors.

Based on this, COVAX anticipates being able to provide participating economies doses of safe and effective vaccines – enough to protect health care and other frontline workers as well as some high-risk individuals – beginning in Q1 2021. The aim is to protect at least 20% of each participating population by the end of the year – unless a participant has requested a lower percentage of doses. At least 1.3 billion of these doses will be made available to the 92 economies eligible for the Gavi COVAX AMC by the end of 2021.

To meet its goal of securing two billion safe and effective vaccines in 2021, COVAX has built a diverse portfolio of vaccine candidates which mitigates the risk of a product failing development, production or regulatory processes, and ensures availability of products suitable for various contexts and settings. This work will continue at pace to enable further supply of vaccines suitable for use across a wide range of populations and settings in 2021 and beyond.

“The progress in vaccine development so far has been extraordinary, and it is clear that we are now assembling the tools we need to bring the acute phase of the pandemic to an end. But we cannot afford to slow our efforts given the speed with which this pandemic continues to wreak havoc,” said Dr Richard Hatchett, CEO of CEPI. “The emergence of new variants of COVID-19 puts into sharp focus the need for us to be one step ahead of the virus by continuing to invest in vaccine R&D – specifically for next-generation vaccine candidates and to be ready for strain changes in existing vaccines – to ensure we have the tools to meet the needs of all populations in all countries for the long term.”