Biological E seeks extension from DCGI for its vaccine shelf life

About 97% adults have already got their primary dose

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on October 15, 2024 by The Health Master

Hyderabad-based Biological E has sought extension of shelf life of its C-19 vaccine Corbevax by up to 12 months from India’s drug regulatory authority (DCGI). The company had started manufacturing in December and is expected to supply 5 crore doses of the vaccine to the government this month.

The shelf life is determined after various tests are conducted to assess how long a vaccine can stay stable and sterile in different environments and temperatures.

“The company has presented stability data and other information required for extension of shelf life of their vaccine and the regulatory authority is examining it,” a person in the know told ET.

The currently assigned shelf-life of the vaccine is six months, which means that the vaccines can be used till six months from the date of manufacture if stored at two to eight degree celsius.

The extension of shelf life will reduce wastage of the vaccine as shelf life of six months means if the vaccine remains unused within the six months from the date of manufacture, they are considered to be expired.

“A shelf life of six months would mean that it would expire in June-July. With vaccine demand dropping, the extension of shelf life gains significance, “added the person. The government is yet to decide on which segment of beneficiaries Corbevax will be administered to.

“About 97% adults have already got their primary dose. Discussions are underway in technical groups on its use,” said a government official.

Biological E had earlier said that it plans to complete production at a rate of 75 million doses per month, anticipating over 100 million doses per month from February 2022 which will enable the company to deliver 300 Million doses.

Corbevax is India’s first indigenously developed protein sub-unit vaccine against the virus. On behalf of the Union Health Ministry, HLL Lifecare Limited, a public sector undertaking, issued the supply order for Corbevax to Biological E in January on behalf of the Union Health Ministry.

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