WHO had issued EUL to Pfizer-BioNTech’s Covid-19 mRNA vaccine on December 31, 2020. Pfizer-BioNTech was the first company to get WHO clearance and signed an advance purchase agreement for the vaccine.
Serum Institute of India (SII) has entered into a deal to supply 11 billion doses of the AstraZeneca-Oxford and Novavax Covid-19 vaccines to the COVAX Facility, but the company would be able to start supplies only after it gets a pre-qualification approval from the World Health Organization (WHO) and permission from the Indian government to export.
The company will supply the vaccines at $3 per dose for low and lower-middle income countries.
SII has applied to the WHO for pre-qualification to start supplies. The application to WHO was made on January 13, 2021, with all the trial data and the company is awaiting approval to start supplies. The WHO Emergency Use Listing (EUL) has not yet been granted for the AstraZeneca vaccine and evaluation processes are currently underway. SII has already supplied vaccines to friendly countries in the neighbourhood as part of the government’s vaccine diplomacy outreach.
WHO had issued EUL to Pfizer-BioNTech’s Covid-19 mRNA vaccine on December 31, 2020. Pfizer-BioNTech was the first company to get WHO clearance and signed an advance purchase agreement for the vaccine. The Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the WHO are co-leads of the COVAX initiative for equitable global access to Covid-19 vaccines with UNICEF as delivery partner. COVAX’s first interim distribution forecast expects availability of the AstraZeneca/Oxford vaccine candidates to COVAX Facility participants in first half of 2021. In the first round around 240 million doses of the SII – AstraZeneca vaccine will be supplied and deliveries are estimated to begin as of late February.
The COVAX Facility has signed agreements with SII for 550 million doses of the AstraZeneca and 550 million doses of the Novavax vaccine as part of its plan to give equitable global access to the Covid-19 vaccine. Pfizer-BioNTech is supplying 40 million doses and AstraZeneca on its own will supply 170 million doses. The first rounds of vaccine distribution is non-binding and may be subject to change.
The WHO EUL will allow countries expedite their own regulatory approval processes to import and administer the vaccine. As per the interim distribution forecast, around 92 low and middle income economies are eligible for delivery of 1.8 billion vaccine doses. India is part of the lower-middle income country list that will receive 9.41 crore vaccines from GAVI.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as additional data on safety, efficacy, quality and a risk management plan. This data will then be reviewed by independent experts and WHO teams.