WHO panel recommends Emergency Use Listing status for Covaxin.
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 Wednesday recommended Covaxin for emergency use status, according to PTI.
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.
"Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that Covaxin vaccine meets WHO standards for protection against COVID, that benefit of the vaccine far outweighs risks and the vaccine can be used across the world," the world health body said.
"Covaxin vaccine was also reviewed 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.
"Glad to see one more vaccine, Covaxin, being granted WHO emergency use listing. The more products we have to fight Covid-19, the better," said WHO DG Tedros Adhanom Ghebreyesus.
Following approval from WHO, Union Health Minister Mansukh Mandaviya thanked the world health body for Emergency Use Listing (EUL) to Made-in-India Covaxin.
Taking to Twitter, Mandaviya wrote, "This is a sign of a capable leadership. This is the story of Modi Ji's resolve."
WHO, however, said, "Available data on vaccination of pregnant women with the Covaxin vaccine are insufficient to assess vaccine safety 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 October 26 had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-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 told PTI.
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 Covaxin up to 12 months from the date of manufacture.
Bharat Biotech was initially given permission for the sale and distribution of Covaxin with a shelf life of six months, which was later extended to nine months, a company spokesperson told PTI.
"The CDSCO has approved the extension of shelf life of Covaxin 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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