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HomePoliticsWorldCovaxin of Bharat Biotech approved by World Health Organisation

Covaxin of Bharat Biotech approved by World Health Organisation

'Covaxin meets WHO standards for protection against Covid-19 and benefits of the vaccine far outweighs risks,' the UN health body said

Covaxin, India’s indigenously developed coronavirus vaccine by Bharat Biotech, has been recommended for emergency use listing by the World Health Organisation (WHO). The Technical Advisory Group of WHO on 3 November recommended for emergency use status.

The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), recommended Emergency Use Listing (EUL) status for Bharat Biotech Covid-19 vaccine Covaxin, sources in the know of the development said.

“The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that vaccine meets WHO standards for protection against Covid-19, that benefit of the vaccine far outweighs risks and the vaccine can be used across the world,” the world health body said.

vaccine was reviewed also by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended the use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above,” it said.

WHO, however, said, “Available data on vaccination of pregnant women with the vaccine are insufficient to assess vaccine or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.”

The WHO is in the process of evaluating Covaxin’s clinical trial data for use of EUL.

The TAG on 26 October had sought “additional clarifications” from the company for to conduct a final “-benefit assessment” for Emergency Use Listing of the vaccine.

“The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin,” a source said.

The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure.

Earlier today, Bharat Biotech said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of its Covid-19 vaccine up to 12 months from the date of manufacture.

Bharat Biotech was initially given permission for the sale and distribution of with a shelf life of six months, which was later extended to nine months, a company spokesperson said.

“The CDSCO has approved the extension of shelf life of up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO,” Bharat Biotech said in a tweet.

The shelf life extension has been communicated to “our stakeholders,” it added.

The approval for the extension of shelf life of the vaccine comes ahead of crucial World Health Organisation (WHO) meeting for a final risk-benefit assessment for the emergency use listing (EUL) for the vaccine.

The WHO’s Technical Advisory Group for EUL last week had sought additional clarifications from Bharat Biotech for Covaxin.


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Omicron variant and Globalization - interesting article by @nfergus


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