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Wednesday, December 08, 2021

Shot in the arm: Covaxin gets WHO approval for emergency use listing

Covaxin WHO approval: The WHO clearance is a significant step in Covaxin being accepted by foreign governments. It will remove uncertainty around overseas travel by Indians inoculated with this vaccine.

By: Express Web Desk | New Delhi |
Updated: November 3, 2021 10:30:22 pm
CovaxinOn October 18, the WHO had said that it was expecting “one additional piece of information” from Bharat Biotech on Covaxin. (Express photo: Amit Chakravarty)

Hyderabad-based vaccine maker Bharat Biotech received a shot in the arm Wednesday as the World Health Organisation (WHO) granted approval to India’s first indigenous Covid vaccine– Covaxin– for emergency use listing (EUL).

The WHO clearance is a significant step in Covaxin being accepted by foreign governments. It will remove uncertainty around overseas travel by Indians inoculated with this vaccine. Moreover, EUL is also a prerequisite for a vaccine to be supplied through COVAX, the global Covid vaccine equity scheme.

WHO Director Dr Tedros Adhanom Ghebreyesus tweeted, “Glad to see one more vaccine, #Covaxin, being granted @WHO emergency use listing. The more products we have to fight #COVID19, the better, but we must keep up the pressure to deliver #VaccinEquity & prioritize access to vulnerable groups who are still waiting for their 1st dose.”

WHO Director Dr Tedros Adhanom Ghebreyesus tweeted, “Glad to see one more vaccine, #Covaxin, being granted @WHO emergency use listing. The more products we have to fight #COVID19, the better, but we must keep up the pressure to deliver #VaccinEquity & prioritize access to vulnerable groups who are still waiting for their 1st dose.”

Covaxin is one of the six vaccines that have received emergency use authorisation from India’s drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V.

“Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin,” Bharat Biotech Chairman and Managing Director Krishna Ella was quoted as saying by news agency PTI.

As an organisation, Bharat Biotech has focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of its vaccines have received WHO prequalification, he added.

“The EUL authorisation for Covaxin will enable us to contribute to accelerating the equitable access of Covid-19 vaccine, and the access to our vaccine globally thereby addressing the current public health emergency,” Ella said.

“The WHO nod for Covaxin is a validation of the tremendous effort made by everyone at Bharat Biotech and our partners. It is also an opportunity for us to create meaningful impact at a global level,” Bharat Biotech Joint Managing Director Suchitra Ella was quoted as saying by PTI. Such an impact can only be orchestrated when multiple stakeholders come together to work towards a common goal. Covaxin is a great example of a successful public-private partnership in developing a world-class COVID-19 vaccine, she added.

In July, Bharat Biotech had announced the safety and efficacy analysis data from Phase III clinical trials of its vaccine and stated that Covaxin demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant.

In the same month, the government told the Rajya Sabha that all documents required for the WHO’s EUL had been submitted by Bharat Biotech, and the global health body had commenced the review process. Last month, the WHO had said that it was expecting “one additional piece of information” from Bharat Biotech.

In a series of tweets back then, the WHO then stated that it could not “cut corners”, and that the timeframe for its EUL was dependent on how quickly vaccine manufacturers were able to provide the required data. The WHO said that once “the information provided addresses all questions raised”, the organisation and its Technical Advisory Group would “complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine”.

In an e-mail response to The Indian Express on the outcome of the meeting that took place on October 26 on the grant of EUL to Covaxin, the WHO said the Technical Advisory Group “expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November”.

Besides Covaxin, the WHO has approved vaccines developed by Pfizer-BioNTech, US pharma majors Johnson & Johnson, Moderna, China’s Sinopharm and Oxford-AstraZeneca for emergency use.

In an another development, Bharat Biotech, earlier in the day, said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of Covaxin up to 12 months from the date of manufacture.

(With PTI inputs)

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