COVAX Announces additional deals to access promising COVID-19 vaccine candidates; plans global rollout starting Q1 2021

Admin on 31 / 12 / 2020 under #COVAX #COVID-19

COVAX now has agreements in place to access nearly two billion doses of several promising vaccine candidates, and laid the groundwork for further doses to be secured through contributions from donors

These agreements mean that all COVAX’s 190 participating and eligible economies will be able to access doses to protect vulnerable groups in the first half of 2021. At least 1.3 billion donor-funded doses will be made available to 92 economies eligible for the Gavi COVAX AMC, targeting up to 20% population coverage by the end of the year.

Funding raised in 2020 and early pledges toward 2021 targets, alongside these agreements, offer clearest pathway yet to ending the acute phase of the pandemic globally by the end of 2021

Geneva/Oslo, 18 December 2020 – COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today announced that it had arrangements in place to access nearly two billion doses of COVID-19 vaccine candidates, on behalf of 190 participating economies. For the vast majority of these deals, COVAX has guaranteed access to a portion of the first wave of production, followed by volume scales as further supply becomes available. The arrangements announced today will enable all participating economies to have access to doses in the first half of 2021, with first deliveries anticipated to begin in the first quarter of 2021 – contingent upon regulatory approvals and countries’ readiness for delivery.

Given these are arrangements for 2 billion doses of vaccine candidates which are still under development, COVAX will continue developing its portfolio: this will be critical to achieve its goal of securing access to 2 billion doses of safe and effective, approved vaccines that are suitable for all participants’ contexts, and available by the end of 2021. However, today’s announcements offer the clearest pathway yet to end the acute phase of the pandemic by protecting the most vulnerable populations around the world. This includes delivering at least 1.3 billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for the COVAX AMC.

The new deals announced today include the signing of an advance purchase agreement with AstraZeneca for 170 million doses of the AstraZeneca/Oxford candidate, and a memorandum of understanding (MoU) with Johnson & Johnson for 500 million doses of the Janssen candidate, which is currently being investigated as a single dose vaccine.. These deals are in addition to existing agreements COVAX has with the Serum Institute of India (SII) for 200 million doses – with options for up to 900 million doses more – of either the AstraZeneca/Oxford or Novavax candidates, as well as a statement of intent for 200 million doses of the Sanofi/GSK vaccine candidate.

In addition to this, COVAX also has – through R&D partnership agreements – first right of refusal in 2021 to access potentially more than one billion doses (based on current estimates from the manufacturing processes under development) that will be produced, subject to technical success and regulatory approval, by candidates in the COVAX R&D Portfolio.

“This commitment is evidence that the world learned an important lesson from the 2009 H1N1 pandemic. Our research and development efforts have begun to pay off. We now have safe and effective vaccines that can protect against COVID-19 and a clear pathway to securing 2 billion doses for the populations at greatest risk all around the world,” said Dr Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI).  “Securing the right of first refusal of successful vaccine production as part of R&D arrangements has helped guarantee equitable access to vaccines, a founding principle of CEPI.   The challenge of delivering the vaccines that have demonstrated success, of completing the development of other promising vaccine candidates to further increase supply, and of ending the acute phase of the pandemic, lies ahead of us.”

Alongside boosting its pathway to two billion doses of approved vaccines through direct agreements with manufacturers, the COVAX Facility has also opened another potential source of vaccines. Published today, the Principles for Dose-Sharing provide a framework for higher-income economies to make additional volumes secured via bilateral deals available through the Facility primarily to AMC participants, on an equitable basis. These principles outline that such doses must be safe and effective, available as early as possible and should be available in substantive volumes as early as possible in 2021 to enable rapid and flexible deployment by the Facility – supporting the overall goal of equitable access.

First deliveries in Q1 2021

Today’s announcements on deals and dose-sharing mean COVAX can plan for the first deliveries of vaccines in the first quarter of 2021, with the first tranche of doses – enough to protect health and social care workers – delivered in the first half of 2021 to all participating economies who have requested doses in this timeframe. This would be followed by further delivery of doses to all participants in the second half of the year – targeting supply of doses equalling up to 20% of participants’ populations (or a lower amount if requested by the participant) by the end of the year. Additional doses to reach higher coverage levels will then be available in 2022. All deliveries are contingent upon several factors, such as regulatory approvals and country readiness.

“The arrival of vaccines is giving all of us a glimpse of the light at the end of the tunnel,” said Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organisation (WHO). “But we will only truly end the pandemic if we end it everywhere at the same time, which means it’s essential to vaccinate some people in all countries, rather than all people in some countries. And we must remember that vaccines will complement, but not replace, the many other tools we have in our toolbox to stop transmission and save lives. We must continue to use all of them."

The COVAX Facility currently has 190 participating economies. This includes 98 higher-income economies and 92 low- and middle-income economies eligible to have their participation in the Facility supported via the financing mechanism known as the Gavi COVAX AMC. Of the 92 economies eligible to be supported by the COVAX AMC, 86 have now submitted detailed vaccine requests, offering the clearest picture yet on actual global demand for COVID-19 vaccines.

In addition to gathering detailed information on participating economies’ vaccine requests, COVAX, through Gavi, UNICEF, WHO, the World Bank, and other partners has been working closely with all countries in the Facility, particularly AMC-eligible participants, to help plan and prepare for the widespread roll out of vaccines. Conditions that determine country readiness include regulatory preparedness as well as the availability of infrastructure, appropriate legal frameworks, training, and capacity, among other factors.

“Securing access to doses of a new vaccine for both higher-income and lower-income countries, at roughly the same time and during a pandemic, is a feat the world has never achieved before – let alone at such unprecedented speed and scale,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance, which leads on procurement and delivery for COVAX. “COVAX has now built a platform that offers the world the prospect, for the first time, of being able to defeat the pandemic on a global basis, but the work is not done: it’s critical that both governments and industry continue to support our efforts to achieve this goal”.

Early pledges towards 2021 fundraising targets

To achieve this ambitious goal, COVAX currently estimates it needs to raise an additional US$ 6.8 billion in 2021 – US$ 800 million for research and development, at least US$ 4.6 billion for the COVAX AMC and US$ 1.4 billion for delivery support.

Support for the COVAX AMC will be critical to ensuring ability to pay is not a barrier to access. Thanks to the generous support of sovereign, private sector, and philanthropic donors, the AMC has met its urgent 2020 fundraising target of US$ 2 billion, but at least US$ 4.6 billion more is needed in 2021 to procure doses of successful candidates as they come through the portfolio. 

The last two weeks have seen a number of pledges made to Gavi for the COVAX AMC, bringing the overall amount raised to US$ 2.4 billion:

Norway has signed a new commitment of NOK 1 billion to the International Finance Facility for Immunisation (IFFIm), to be paid from 2021 to 2030. This funding will support the Gavi COVAX AMC and comes on top of earlier commitments of NOK 164.1 million in direct funding and $6.25 million in funding transferred from the PCV AMC to support the Gavi COVAX AMC.

Canada pledged CAD 75 million in funding to support the delivery of COVID-19 vaccines in lower income economies as part of the Gavi COVAX AMC. This includes a CAD 5 million investment in the development of a mechanism to equitably reallocate vaccine doses through the COVAX Facility, either by donation or exchange.

Kuwait has confirmed a pledge of US$ 10 million to the Gavi COVAX AMC.

Denmark has announced, subject to parliamentary approval, a commitment of DKK 50 million to Gavi COVAX AMC.

New Zealand has pledged NZ$ 10 million to the Gavi COVAX AMC, in addition to NZ$ 7 million pledged earlier this year for the AMC.

Netherlands has signed and paid a commitment of EUR 5 million to the Gavi COVAX AMC

Singapore has pledged US$ 5 million to the Gavi COVAX AMC

The King Salman Humanitarian Aid and Relief Center (KSrelief) / Gamers Without Borders have confirmed a pledge of US$ 1.3 million to the Gavi COVAX AMC

Estonia has signed a commitment of EUR 70,000 to the Gavi COVAX AMC

In addition to these pledges, Team Europe confirmed financial support of EUR 500 million, through EUR 400 million European Investment Bank loan and EUR100 million grant to Gavi, in support of equitable access through COVAX.

The goal of COVAX is to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO prequalification by the end of 2021. These vaccines will be offered equally to all participating countries, proportional to their populations, initially prioritising healthcare workers then expanding to cover vulnerable groups, such as the elderly and those with pre-existing conditions. Further doses will then be made available based on country need, vulnerability and COVID-19 threat. The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use.

Quotes from partners

Karina Gould, Minister of International Development, Government of Canada said: “We know that as long as one country is at risk, we are all at risk. The COVAX Facility is the key to ending this pandemic and will only work if we all come together. Now is the time to make our commitment to equitable access a reality, so that everyone, everywhere has access to a life-saving vaccine.”

Dr Kwaku Agyeman Manu, Minister of Health for Ghana said: The nearly 2 billion COVID-19 vaccine doses announced today by COVAX is a welcome first step, but our journey is not yet over. As we’ve learned with routine immunisation vaccines don’t save lives, vaccination does. This means we need the health infrastructure in place - from supply chain and logistics to well- trained health workers - to ensure the effective and streamlined distribution of vaccines. For this we call on governments, manufacturers and the private sector to make urgent and necessary investments in COVAX so that no one is left behind; because ultimately no one is safe until everyone is safe.

Dag-Inge Ulstein, Norway’s Minister of International Development and Co-chair of the ACT-A Facilitation Council, said: “The good news is that many countries, foundations and some private companies have already provided support to this important collective effort. The bad news is that more is needed. We need to look beyond the health sector and the international development sector if we are to find the political and financial resources required to combat the pandemic and its many different impacts.”

Wendy Morton, Minister for Global Health at the Foreign, Commonwealth and Development Office of the UK, which also hosted the Global Vaccine Summit in June, said: “The UK has played the leading role in championing global access to coronavirus vaccines, including by being the largest donor to the COVAX Advance Market Commitment. No one is safe until we are all safe. Along with our international partners, the UK is working hard to ensure vaccines get to everyone who needs them.”

Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC) said: “Since the beginning of the COVID-19 pandemic, Africa CDC has established several trusted partnerships across the globe. The COVAX partnership is one of such very critical alliances that will allow Africa to secure early access to COVID-19 vaccine needed to start vaccinating our populations across the continent.”

Henrietta Fore, Executive Director of UNICEF said: “This is an unprecedented undertaking — addressing a global pandemic while ensuring we do not leave the world’s poorest behind. UNICEF is bringing the full weight of our experience as the world’s largest single procurer of vaccines to help secure and deliver COVID-19 vaccines, and help countries prepare to receive and administer them.”

Dr Ngozi-Okonjo Iweala, co-chair of the COVAX Coordination Meeting and Gavi Board Chair said: “Nine months ago, it was hard to imagine that we would have more than one promising vaccine candidate and be in a position to make them available to both high-income countries and lower-income countries simultaneously. The global community has rallied, and we now have a platform, COVAX, that will do this. It’s time to stop questioning it and give it the support it needs to bring the pandemic to an end as swiftly as possible.” 

Jane Halton, co-chair of the COVAX Coordination Meeting and Chair of CEPI said: “Science will give us the tools to fight this pandemic, but equitable access will allow us to beat it. Today marks a significant moment towards our goal of fair and equitable access to COVID-19 vaccines for those most at risk around the world. We now have a clear pathway to our goal of delivering 2 billion doses of vaccine in 2021 - enabled by COVAX R&D investments and deals with manufacturers - which can bring an end to the acute phase of the pandemic globally. In addition, governments can now demonstrate their continued commitment to this goal by contributing doses to COVAX of vaccines secured through bilateral deals. Equitable access to vaccines is in all of our interests, and we’re now a significant step closer to making this a reality.”

Mesfin Teklu Tessema, civil society representative of the COVAX Coordination Meeting and Senior Director, Head of Health Unit, International Rescue Committee said: "The COVAX Facility is our best hope to ending this pandemic as quickly as possible with equity as its grounding force. This announcement today is an important milestone and proof that doses are forthcoming to those most in need everywhere."

Adar Poonawalla, CEO of the Serum Institute of India (SII) said: "We are delighted to announce that we have signed for a 100mn doses of Novavax and another 100mn doses of AstraZeneca-Oxford vaccines with COVAX, with an option of extending it by 900mn doses. The advance purchase commitments under COVAX initiative is encouraging as it will further bolster our fight and ensure equitable access at the most affordable price from Serum Institute of India.”

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Today’s Agreement is a significant milestone for global access to the AZD1222 vaccine. Our collaboration with COVAX is testament to AstraZeneca’s commitment to broad, equitable access at no profit during the pandemic period. We now look forward to progressing our work with COVAX partners to ensure that as many people as possible around the world can access a safe, effective vaccine – wherever they live.”

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson said: “Since we initiated development of our COVID-19 vaccine candidate, Johnson & Johnson has remained committed to ensuring access to vaccines on a not-for-profit basis for emergency pandemic use. Equitable global access, inclusive of lower income countries, is critical to helping end the COVID-19 pandemic.”

Thomas B. Cueni, Director General, International Federation of Pharmaceutical Manufacturers (IFPMA) said: The reason why we can mark today as a milestone for COVAX securing 2 billion doses of promising vaccines is because the vaccine makers have pulled out all the stops and have delivered beyond all expectations.  So let’s indeed mark this important milestone in ensuring fair and equitable access to vaccines which we have committed to from the outset of the pandemic. But let us also remember, that we would not be where we are if science and the innovation ecosystem that allows the biopharmaceutical to develop and manufacture life saving treatments had not risen to the challenge, so that there are different types of vaccines that will be manufactured in historic quantities. Looking to 2021, it is essential that all COVAX partners and governments focus on getting things done and secure the funds need.

Notes to editors

The full list of deals that have so far been secured by COVAX on behalf of the Facility is as follows:

170 million doses of the AstraZeneca/Oxford candidate, via an advance purchase agreement between Gavi and AstraZeneca, and enabled by a partnership agreement with CEPI to fund scale-out of manufacturing

200 million doses (and options for up to 900 million more) of the AstraZeneca/Oxford or Novavax candidates, via an agreement between Gavi, the Serum Institute of India, and the Bill and Melinda Gates Foundation

500 million doses of the Janssen candidate, via a memorandum of understanding with Johnson & Johnson

200 million doses of the Sanofi/GSK vaccine candidate, via a statement of intent between Gavi, Sanofi and GSK

First right of refusal for a potential combined total of over 1 billion doses in 2021 (based on current estimates from the manufacturing processes under development) of promising vaccine candidates, via R&D partnership agreements with CEPI - that will be produced, subject to technical success and regulatory approval, by candidates in the COVAX R&D Portfolio.

As part of the COVAX R&D portfolio, CEPI has invested in 10 vaccine candidates. 9 of these candidates are still in development, and 7 are in clinical trials.

AstraZeneca/ University of Oxford (Phase 3)

Clover Biopharmaceuticals, China (Phase 1)

CureVac, Germany (Phase 2B/3)

Inovio, USA (Phase 2)

Institut Pasteur/Merck/Themis, France/USA/Austria (Phase 1)

Moderna, USA (Phase 3)

Novavax, USA (Phase 3)

SK bioscience, South Korea (Preclinical)

University of Hong Kong, Hong Kong (Preclinical)

University of Queensland/ CSL, Australia (Phase 1, programme discontinued)