COVAX Statement on WHO Emergency Use Listing for AstraZeneca/Oxford COVID-19 Vaccine

COVAX
Oxford_Astrazeneca Vaccine

Geneva / New York / Oslo — 16 February 2021 The Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance (Gavi), and the World Health Organization (WHO), as co-leads of the COVAX initiative for equitable global access to COVID-19 vaccines, alongside key delivery partner UNICEF, are pleased to welcome the news that two versions of the AstraZeneca/Oxford COVID-19 vaccine have been given WHO Emergency Use Listing (EUL). Yesterday's announcement means that two versions of the AstraZeneca/Oxford vaccine, produced by AstraZeneca-SK Bioscience (AZ-SKBio) and the Serum Institute of India (AZ-SII), are now available for global rollout through the COVAX Facility.

Building on the early information provided in the interim distribution forecast published on 3 February 2021, COVAX will now complete the process of final Q1/Q2 allocations of the AstraZeneca/Oxford vaccine to Facility participants. Information on these final allocations will be communicated to all participants and published online the week of February 22nd.

In order for doses to be delivered via this first allocation round, several critical pieces must be in place:

- All Facility participants must have given national regulatory authorisation for the vaccines in question, a process which can be expedited by issuing special authorisations for use based on granting of WHO EUL.

- All Facility participants must have signed indemnity agreements with the manufacturers in question in order to receive doses through COVAX. The COVAX Facility is helping to facilitate the process of getting these agreements in place. In particular, COVAX is supporting AMC-eligible participants by negotiating a template indemnity agreement on their behalf — saving time and resources — and establishing a no-fault compensation mechanism and fund.

- AMC-eligible economies must have submitted National Deployment and Vaccination Plans (NDVPs) through the COVID-19 Partners Platform, that have then been reviewed and validated by COVAX.

In preparation for this unprecedented global rollout, COVAX partners have been working closely with all Facility participants for many months, providing support for regulatory and indemnity and liability issues as well as the submission of completed NDVPs. Throughout this process, Facility participants have been moving at speed to ensure all preparations are in place for the first deliveries.

As participants fulfil the above criteria and finalise readiness preparations, COVAX will issue purchase orders to the manufacturer and ship and deliver doses via an iterative process. This means deliveries for this first round of allocation will take place on a rolling basis and in tranches.

Due the high number of doses available as well as the high number of countries getting ready for delivery in Q1 2021, the capacity of supplier and freight forwarders will be under considerable pressure. Shipment timelines will be impacted by logistical preparedness and delivery lead times, which may vary depending on the location of the receiving participant.

Based on this, COVAX anticipates the bulk of the first round of deliveries taking place in March, with some early shipments to those that have already fulfilled the above criteria, occurring in late February. More information related to these first deliveries will be shared in the coming days.

Media Contacts

Meg Sharafudeen, Gavi
+41 79 711 5554
[email protected]

Iryna Mazur, Gavi
+41 79 429 3671
[email protected]

Evan O'Connell, Gavi
+33 6 17 57 21 26
[email protected]

Laura Shevlin, Gavi
[email protected]

CEPI Press Office
+44 7387 055214
[email protected]

WHO Press Office
[email protected]

Sabrina Sidhu, UNICEF
+19174761537
[email protected]