COVAX announces new agreement, plans for first deliveries

COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, 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."

About COVAX

COVAX, the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, is co-led by CEPI, Gavi and WHO - working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, and others. It is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to both higher-income and lower-income countries.

CEPI is leading on the COVAX vaccine research and development portfolio, investing in R&D across a variety of promising candidates, with the goal to support development of three safe and effective vaccines which can be made available to countries participating in the COVAX Facility. As part of this work, CEPI has secured first right of refusal to potentially over one billion doses for the COVAX Facility to a number of candidates, and made strategic investments in vaccine manufacturing, which includes reserving capacity to manufacture doses of COVAX vaccines at a network of facilities, and securing glass vials to hold 2 billion doses of vaccine. CEPI is also investing in the ‘next generation’ of vaccine candidates, which will give the world additional options to control COVID-19 in the future.

Gavi is leading on procurement and delivery for COVAX, coordinating the design and implementation of the COVAX Facility and the COVAX AMC and working with Alliance partners UNICEF and WHO, along with governments, on country readiness and delivery. The COVAX Facility is the global pooled procurement mechanism for COVID-19 vaccines through which COVAX will ensure fair and equitable access to vaccines for all 190 participating economies, using an allocation framework formulated by WHO. The COVAX Facility will do this by pooling buying power from participating economies and providing volume guarantees across a range of promising vaccine candidates. The Gavi COVAX AMC is the financing mechanism that will support the participation of 92 low- and middle-income countries in the Facility, enabling access to donor-funded doses of safe and effective vaccines. UNICEF and the Pan-American Health Organisation (PAHO) will be acting as procurement coordinators for the COVAX Facility, helping deliver vaccines to all participants.

WHO has multiple roles within the COVAX: among other things it supports countries as they prepare to receive and administer vaccines and does so in partnership with UNICEF. It provides normative guidance on vaccine policy, regulation, safety, R&D, allocation, and country readiness and delivery. Its Strategic Advisory Group of Experts (SAGE) on Immunization develops evidence-based immunization policy recommendations. Its Emergency Use Listing (EUL)/prequalification programmes ensure harmonized review and authorization across member states. It provides global coordination and member state support on vaccine safety monitoring. It developed the target product profiles for COVID-19 vaccines and provides R&D technical coordination. Along with COVAX partners, it is developing a no-fault compensation scheme for indemnification and liability issues. COVAX is part of the Act accelerator which WHO launched with partners in 2020.

About Gavi, the Vaccine Alliance

Gavi, the Vaccine Alliance is a public-private partnership that helps vaccinate half the world’s children against some of the world’s deadliest diseases. Since its inception in 2000, Gavi has helped to immunise a whole generation - over 822 million children - and prevented more than 14 million deaths, helping to halve child mortality in 73 lower-income countries. Gavi also plays a key role in improving global health security by supporting health systems as well as funding global stockpiles for Ebola, cholera, meningitis and yellow fever vaccines. After two decades of progress, Gavi is now focused on protecting the next generation and reaching the unvaccinated children still being left behind, employing innovative finance and the latest technology - from drones to biometrics - to save millions more lives, prevent outbreaks before they can spread and help countries on the road to self-sufficiency.

The Vaccine Alliance brings together developing country and donor governments, the World Health Organization, UNICEF, the World Bank, the vaccine industry, technical agencies, civil society, the Bill & Melinda Gates Foundation and other private sector partners.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 11 partnerships to develop vaccines against the novel coronavirus. The programmes are leveraging rapid response platforms already supported by CEPI as well as new partnerships.

Before the emergence of COVID-19, CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

About WHO

The World Health Organization provides global leadership in public health within the United Nations system. Founded in 1948, WHO works with 194 Member States, across six regions and from more than 150 offices, to promote health, keep the world safe and serve the vulnerable. Our goal for 2019-2023 is to ensure that a billion more people have universal health coverage, to protect a billion more people from health emergencies, and provide a further billion people with better health and wellbeing.

About ACT-Accelerator

The Access to COVID-19 Tools ACT-Accelerator, is a new, ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, European Commission, France and The Bill & Melinda Gates Foundation in April 2020.

The ACT-Accelerator is not a decision-making body or a new organisation, but works to speed up collaborative efforts among existing organisations to end the pandemic. It is a framework for collaboration that has been designed to bring key players around the table with the goal of ending the pandemic as quickly as possible through the accelerated development, equitable allocation, and scaled up delivery of tests, treatments and vaccines, thereby protecting health systems and restoring societies and economies in the near term. It draws on the experience of leading global health organisations which are tackling the world’s toughest health challenges, and who, by working together, are able to unlock new and more ambitious results against COVID-19. Its members share a commitment to ensure all people have access to all the tools needed to defeat COVID-19 and to work with unprecedented levels of partnership to achieve it.

The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.