MUMBAI: The World Health Organisation has asked Serum Institute of India to submit its data from clinical trials of the AstraZeneca/Oxford vaccine conducted in India for prequalification, to kick off the distribution of vaccines under the Covax Facility.
WHO prequalification is a service the global organisation provides to facilitate access to medicines that meet unified standards of quality, safety and efficacy. So far this service was for medicines and vaccines against HIV/AIDS, malaria and tuberculosis; now, it is also being extended for Covid-19.
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.
“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,” Tedros Adhanom, director general of WHO, had said earlier this week. “We also look forward d to Serum Institute of India submitting full data sets for rapid assessment so WHO can determine whether we can recommend their AstraZeneca vaccine for international use.”
An email sent to Serum Institute on when it plans to apply for WHO prequalification did not elicit any response as of press time Wednesday.
Officials aware of the development told ET that the company should be registering the vaccine for prequalification this week.
Covax Facility is a collaboration between WHO, GAVI-Vaccine Alliance, and Coalition of Epidemic Preparedness and Innovation (CEPI) 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.
Serum Institute of India is one of the manufacturers that has signed up to supply up to 400 million doses of vaccines to the Covax Facility. In the first quarter, the company is expected to supply 200 million doses of the AstraZeneca/Oxford vaccine which it has developed in India and branded as Covishield.
Serum also has a tieup with US drug maker Novavax to supply vaccines to the Covax Facility.
Indian vaccine manufacturers, with a capacity to manufacture more than a billion vaccine doses, are expected to play a crucial role in distribution of Covid-19 vaccines.
Serum Institute and Bharat Biotech have already struck deals with the South African government to supply one million doses of vaccines and Bharat Biotech has 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 those at high risk categories starts across all countries.
A WHO team is also working with producers of Sinovac and Sinopharm vaccines developed in China to assess compliance with international quality manufacturing practices ahead of potential emergency use listing by WHO, Adhanom had said.