The Serum Institute of India, which is manufacturing and testing the Oxford / AstraZeneca coronavirus vaccine in the country, said Monday. awaited regulatory approval to take in a few days. Serum CEO Adar Poonawalla said the vaccine, called Covishield in India, should be licensed by January.
“The emergency use authorization by the UK drug regulator for the Oxford-AstraZeneca Covid-19 vaccine is expected by the end of December or the first week of January. Also in India, we expect regulatory approval of the Covishield vaccine in a few days. We must respect the process and give drug regulators in the UK and India enough time to review the data. Nobody wants to compromise on safety and we look forward to good news in the new year, ”Poonawalla said.
Last week, the Serum Institute of India presented additional data to the national drug regulator while looking for the US application. The UK regulatory agency for medicines and medical devices is also considering data to grant an emergency use license for the Oxford vaccine. UK approval can be an added bonus in obtaining regulatory go-ahead for India.
“India will be given priority as most of the 50 million doses stored at the Serum Institute will be for the country. India is part of the COVAX facility and we will give 50% of everything we produce to India and Covax at the same time. Every month we can produce more than 50-60 million doses of the Covishield vaccine and we should have 100 million doses every month by March 2021, ”Poonawalla said while speaking to journalists online.
“Everybody wants the vaccine and we plan to administer it fairly. Initially, during the first month, most of the doses will be administered to India, and to export to other countries we will have to go through the WHO prequalification procedure that will take about a month, ”said Poonawalla. He also said that SII expected to start up a third production plant by March next year. “By July 2021, we should have 300 million doses,” he said.
“The first six months of 2021 may see a global shortage, but that may decrease by August as other vaccine manufacturers will be able to supply as well,” he said. Meanwhile, Poonawalla refrained from answering questions related to the status of immunogenicity data, reiterating that the drug regulator should be given enough time as they would review data not only from Indian trials but also from other countries.
“We have two more vaccine candidates after AstraZeneca and Novavax and in another year we should have our own vaccine,” Poonawalla said.
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