India is likely to get a vaccine against coronavirus disease (Covid-19) in the New Year, hinted the country’s apex drug regulator during a webinar on the science behind the vaccine development that enabled it to reach from the lab to the people in less than twelve months.
“We will have a Happy New Year with something in hand, that’s all can hint at,” said VG Somani, drug controller general of India (DCGI), on Thursday.
The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) will meet on January 1 to consider the emergency-use authorisation application of three companies—Pfizer, Serum Institute of India that is to manufacture the Oxford AstraZeneca vaccine, and Bharat Biotech’s Covaxin.
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This will be the second meeting of the SEC with the companies to examine the data that has been produced so far.
Somani said that the approval process was fast-tracked in view of the pandemic by quickly processing all applications, allowing parallel phase 1 and 2 trials without waiting for complete data. “There has been no compromise on the safety of efficacy of the data. The only thing is that the regulator has accepted partial data,” he said.
Representatives from the industry appreciated the hand-holding and quick assessment by the regulator. The manufacturing and stockpiling licenses granted by the drug regulator also helped the companies prepare for a massive vaccination drive.
“With the manufacturing and stockpiling license, the Serum Institute of India has already been able to stockpile 75 million doses of the Oxford AstraZeneca vaccine and by the first week of January we will have 1 million doses. Nobody across the world has so much stock and we can start supplying as soon as we get the approval. After the phase 2 data of Novovax is released, we will start stockpiling the other vaccine too,” said Umesh Shalingam from SII, who was present at the webinar.