WHO approves Bharat Biotech’s Covaxin for emergency use

The World Health Organisation (WHO) on November 3 approved Covaxin, the COVID-19 vaccine developed by Indian pharmaceutical firm Bharat Biotech Ltd, for emergency use.

The Technical Advisory Group of WHO, which met earlier to decide on Covaxin, has recommended emergency use listing (EUL) status for the vaccine for use on all age groups above 18. The two doses of the vaccine are to be administered at a gap of four weeks, it said.

“WHO has granted emergency use listing (EUL) to COVAXIN (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19,” the global health body tweeted.

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

The emergency use nod for Covaxin comes at the end of a lengthy process that lasted for over six months. Bharat Biotech had approached the WHO on April 19 seeking EUL status for its jab and submitted data related to its safety, efficacy, and stability in July.

The global health body’s approval will facilitate more accessible international travel for those who have taken the Covaxin jab. They would not be required to undergo the stringent travel curbs imposed on unvaccinated passengers.

In the past week, the WHO had said it was expecting one additional piece of information from Bharat Biotech regarding Covaxin and emphasized that it has to thoroughly evaluate to ensure vaccines are safe and “cannot cut corners” before recommending a vaccine for emergency use.

Covaxin, administered to over 1.2 million beneficiaries in India, has demonstrated 78 percent effectiveness against symptomatic cases and 65.2 percent protection against the new Delta variant.

The vaccine “is extremely suitable for low- and middle-income countries due to easy storage requirements,” the WHO said.

Why is WHO nod crucial?

The WHO nod for Covaxin’s emergency use is crucial for its widespread acceptability as a safe and effective vaccine.

Recognition from the global health body will allow people vaccinated with Covaxin to travel abroad without restrictions as several countries only recognize COVID-19 vaccines that have been approved by WHO.

Covaxin has received regulatory clearances in Iran, Mexico, Oman, Greece, Nepal, and Australia, apart from India. With the EUL status accorded by WHO, more countries are expected to add Covaxin to the list of vaccines recognized under their jurisdictions.

The EUL status “allows countries to expedite their regulatory approval to import and administer COVID-19 vaccines”, the WHO said in the statement which announced its emergency use approval for Covaxin.

The health body added that the emergency use listing is also essential to supply vaccines under the COVAX framework to low and middle-income countries.

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