India is likely to get a coronavirus disease (Covid-19) vaccine in the New Year, the country’s top drug regulator hinted during a webinar on the science behind the vaccine’s development that allowed it to arrive from the lab. to people in less than 12 months.
“We will have a Happy New Year with something in hand, that’s all I can hint at,” VG Somani, Comptroller General of Drugs of India (DCGI) said Thursday.
The subject matter expert committee (SEC) of the Central Drug Control Organization (CDSCO) will meet on January 1 to consider the application for emergency use authorization from three companies: Pfizer, Serum Institute of India, which will manufacture the Oxford AstraZeneca vaccine, and Covaxin from Bharat Biotech.
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This will be the SEC’s second meeting with the companies to examine the data that has been produced thus far.
Somani said the approval process was sped up in light of the pandemic by quickly processing all applications, allowing for parallel phase 1 and 2 trials without waiting for full data. “The safety or efficacy of the data has not been compromised. The only thing is that the regulator has accepted partial data ”, he said.
Industry representatives appreciated the regulator’s support and quick assessment. Manufacturing and storage licenses granted by the drug regulator also helped companies prepare for a mass vaccination campaign.
“With the manufacturing and storage license, the Serum Institute of India (SII) has already been able to store 75 million doses of the Oxford AstraZeneca vaccine and by the first week of January we will have 1 million doses. Nobody in the world has that much stock and we can start supplying as soon as we get approval. After the Novovax phase 2 data is released, we will also start stocking the other vaccine, ”said Umesh Shalingam from IBS, who was present at the webinar.
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