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Govt Expert Panel Seeks More Data from SII, Bharat Biotech for Full Market Approval for Covaxin, Covishield

The government’s Subject Expert Committee (SEC) on Friday sought more data from Bharat Biotech and Serum Insitute of India (SII) before granting complete market approval for their Covid-19 vaccines, Covaxin and Covishield, respectively.

Sources said the SEC asked both the companies to come back with specific conditions backed with data for the full market approval. The SEC, according to sources, was of the view that it cannot allow SII and Bharat Biotech to sell Covaxin and Covishield in the open market till the government is mapping vaccination through specific nationwide drives via the Cowin app.

Sources also added that the data, which has been sought from both the companies, has been asked in the compiled form, rather than ongoing rolling data. Bharat Biotech has already submitted it now, while the SII will furnish it soon.

A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions. For full market authorisation, the regulator would need to evaluate more data about the vaccines collected over a longer period of time.

The indigenous Covaxin was approved on January 3, 2021, in emergency-use authorisation (EUA) mode. It was approved to be administered to children over 12 years of age and has been given to kids aged over 15 years from January 3, 2022. About 3 crore children have already been vaccinated. The full market authorisation for the vaccine will further help the company in exports.

On October 25, SII had filed an application with the DCGI, seeking regular market approval for Covishield, which is also authorised for emergency use in the country.

EUA does not represent approval of a vaccine in the full statutory term but authorises the use of an unapproved product or unapproved use of an approved product in a declared state of emergency such as a pandemic.

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Source: News18