WHO approves Bharat Biotech's Covaxin for emergency use

Vial of Covaxin (File image)

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 in the day 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.

#Covaxin EUL expands the availability of , the most effective medical tools we have to end #COVID19. It was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan & suitability in low- & middle-income countries.

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— World Health Organization (WHO) (@WHO) November 3, 2021

The emergency use nod for Covaxin comes at the end of a length 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.

Also Read | Covaxin shelf-life increased to 12 months from date of manufacture

The global health body's approval will facilitate easier international travel for those who have taken the Covaxin jab, as they would not be required to undergo the stringent travel curbs imposed on unvaccinated passengers.

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

Covaxin, which has been 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.

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 recognise COVID-19 vaccines that have been approved by WHO.

Covaxin has so far 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 recognised under their jurisdictions.

The EUL status "allows countries to expedite their own 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.