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India will likely start the new year with a Covid vaccine, hints DCGI


India is likely to receive a coronavirus disease (Covid-19) vaccine in the New Year, the country’s drug regulator hinted during a webinar on the science behind the vaccine’s development that allowed it to get from the lab to people in less than twelve months.

“We will have a Happy New Year with something in hand, that’s all that can be hinted at,” said VG Somani, the drug controller general of India (DCGI), on Thursday.

The Subject Matter Expert Committee (SEC) of the Central Standard Medicines Control Organization (CDSCO) will meet on January 1 to consider the application for emergency use authorization from three companies: Pfizer, Serum Institute of India that 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 trials of phases 1 and 2 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 hand and quick assessment. Manufacturing and storage licenses issued by the drug regulator also helped companies prepare for a mass vaccination campaign.

“With the manufacturing and storage license, the Serum Institute of India 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. No one in the world has that many stocks and we can start supplying as soon as we get approval. After the Novovax phase 2 data is released, we will also start to stock the other vaccine, ”said Umesh Shalingam from IBS, who was present at the webinar.

Hindustan Times