The Serum Institute of India, which is manufacturing and testing Oxford/AstraZeneca’s coronavirus vaccine in the country, said on Monday it expected regulatory approval for the shot in a few days. Serum’s Chief Executive Adar Poonawalla said the vaccine, named Covishield in India, should be licensed by January.
“The emergency use authorisation by the UK drug regulator for the Oxford-AstraZeneca vaccine against Covid-19 is expected by December end or first week of January. In India too, we are hoping for regulatory approval for the Covishield vaccine in a few days. We must respect the process and give the drug regulators in the UK and India enough time to review the data. No one wants to compromise on safety and we hope for some good news in the new year,” Poonawalla said.
Last week, the Serum Institute of India submitted additional data to the national drug regulator while seeking EUA application. The UK Medicines and Healthcare products regulatory agency is also considering data for granting emergency use licence to the Oxford vaccine. The UK approval can be an added advantage in getting regulatory nod for India.
“India will be given priority as a majority of the stockpiled 50 million doses at Serum Institute will be for the country. India is part of COVAX facility and we will give 50 per cent of everything we make to India and to Covax at the same time. Every month we can churn out more than 50-60 million doses of Covishield vaccine and we should have 100 million doses every month by March 2021,” Poonawalla said while speaking to reporters online.
“Everyone wants the vaccine and we plan to give it equitably. Initially, for the first month, most of the doses will be given to India, and to export to other countries we will have to go through the WHO prequalification procedure that will take a month or so,” Poonawalla said. He further said that SII was hoping to commission a third production facility by March next year. “By July 2021, we should have 300 million doses,” he said.
“The first six months of 2021 can see a shortage globally, but that can ease off by August as other vaccine manufacturers also will be able to supply,” he said. Poonawalla, meanwhile, refrained from answering questions related to status of immunogenicity data and reiterated that the drug regulator should be given enough time as they would review data not just from Indian trials but also from other countries.
“We got two more vaccine candidates after AstraZeneca and Novavax and in another year we should have our own vaccine,” Poonawalla said.
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