SII to provide Covishield clinical trial data to WHO to begin global supply

As India begins with the massive inoculation drive, The World Health Organization has asked Serum Institute of India to submit its data from clinical trials of the AstraZeneca/Oxford vaccine conducted in India for prequalification, to begin the distribution of vaccines under the Covax Facility.


WHO prequalification is a service to facilitate access to medicines that meet unified standards of quality, safety and efficacy. Earlier this service was only for medicines and vaccines against HIV/AIDS, malaria and tuberculosis but now has been extended for Covid-19 as well. The prequalification makes it easier for companies to launch products across the world, specifically in low and middle-income countries, as it signifies uniform standards.

Tedros Adhanom, Director General of WHO said, “WHO continues to ask vaccine manufacturers from around the world to move swiftly to provide the necessary data that will allow us to consider them for emergency use listings. We also look forward to SII submitting full data sets for rapid assessment so WHO can determine whether we can recommend their AstraZeneca vaccine for international use.”

To ensure equitable distribution of Covid-19 vaccines to countries that neither have pre-purchase agreements with vaccine makers nor have manufacturing capabilities in their countries, Covax Facility is collaboration between WHO, GAVI-Vaccine Alliance and Coalition of Epidemic Preparedness and Innovation (CEPI).

Serum Institute of India has signed up to supply up to 400 million doses of vaccines to the Covax Facility. In the first quarter, 200 million doses of the Covishield is expected to be supplied. SII has also has a tie-up with Novavax, US drug maker, to supply vaccines to the Covax Facility.

Both, Serum Institute and Bharat Biotech have already struck deals with the South African government to supply one million doses of vaccines. Bharat Biotech has also announced that it will be supplying vaccines to Brazil.

The WHO director general has called for a collective commitment so that within the next 100 days vaccination of health workers and the vulnerable population in all countries can start.