Boost for Covaxin’s pending approval: Bharat Biotech to meet WHO today

23rd June 2021

23rd June 2021

Bharat Biotech, manufacturer of India's homegrown vaccine against Covid-19 Covaxin, would attend a pre-submission meeting with the World Health Organization (WHO) today. 

Earlier on June 18, the WHO had accepted its Expression of Interest (EoI) for coronavirus vaccine. Though the meeting will not be a detailed review on the product, the vaccine maker will have an opportunity to submit a summary on overall quality of the jab, according to the WHO.

The announcement comes a boost to the Indian vaccine manufacturer as it has been awaiting approval. 

The Hyderabad-based Bharat Biotech last month had submitted 90% of the documentation needed for WHO’s Emergency Use Listing, the company said. It had further said that the rest of the documents would be submitted this month.

Meanwhile, an expert panel of the country's central drugs authority, Drugs Controller General of India (DGCI) reviewed and accepted the phase 3 trial data of Covaxin on Tuesday. "The required data was submitted by the company, and the subject expert committee went through it today. The experts were satisfied with the results presented, and the vaccine efficacy is confirmed at 77.8%.”

 

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