The firm will provide the vaccines at $3 per dose for low and reduced-middle earnings nations.
Serum Institute of India (SII) has entered into a deal to provide 11 billion doses of the AstraZeneca-Oxford and Novavax Covid-19 vaccines to the COVAX Facility, but the firm would be in a position to start off supplies only soon after it gets a pre-qualification approval from the World Health Organization (WHO) and permission from the Indian government to export.
The firm will provide the vaccines at $3 per dose for low and reduced-middle earnings nations.
SII has applied to the WHO for pre-qualification to start off supplies. The application to WHO was created on January 13, 2021, with all the trial information and the firm is awaiting approval to start off supplies. The WHO Emergency Use Listing (EUL) has not however been granted for the AstraZeneca vaccine and evaluation processes are at the moment underway. SII has currently supplied vaccines to friendly nations in the neighbourhood as element 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 1st firm to get WHO clearance and signed an advance acquire 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 international access to Covid-19 vaccines with UNICEF as delivery companion. COVAX’s 1st interim distribution forecast expects availability of the AstraZeneca/Oxford vaccine candidates to COVAX Facility participants in 1st half of 2021. In the 1st round about 240 million doses of the SII – AstraZeneca vaccine will be supplied and deliveries are estimated to commence 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 element of its program to give equitable international access to the Covid-19 vaccine. Pfizer-BioNTech is supplying 40 million doses and AstraZeneca on its personal will provide 170 million doses. The 1st rounds of vaccine distribution is non-binding and may possibly be topic to alter.
The WHO EUL will permit nations expedite their personal regulatory approval processes to import and administer the vaccine. As per the interim distribution forecast, about 92 low and middle earnings economies are eligible for delivery of 1.8 billion vaccine doses. India is element of the reduced-middle earnings nation list that will get 9.41 crore vaccines from GAVI.
The EUL pathway requires a rigorous assessment of late phase II and phase III clinical trial information as nicely as more information on security, efficacy, good quality and a threat management program. This information will then be reviewed by independent professionals and WHO teams.