WHO gives Covaxin its stamp of approval

The approval, which comes after a long wait, will allow for a larger recognition of Covaxin by other countries to allow Indian travellers who have taken the dose to qualify for exemptions that countries offer to those vaccinated
The WHO on Wednesday granted emergency use listing (EUL) to Bharat Biotech’s Covid-19 vaccine Covaxin. (HT FILE)
The WHO on Wednesday granted emergency use listing (EUL) to Bharat Biotech’s Covid-19 vaccine Covaxin. (HT FILE)
Updated on Nov 04, 2021 07:01 AM IST
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ByRhythma Kaul, New Delhi

The World Health Organization (WHO) on Wednesday granted emergency use listing (EUL) to Bharat Biotech’s Covid-19 vaccine Covaxin, the UN health body announced, putting its stamp of approval on the safety and efficacy of India’s indigenous vaccine, and also endorsing the manufacturing abilities of its maker.

The approval, which comes after a long wait, will allow for a larger recognition of Covaxin by other countries to allow Indian travellers who have taken the dose to qualify for exemptions that countries offer to those vaccinated.

“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 #COVID19,” WHO said in a tweet.

Union health minister Mansukh Mandaviya thanked WHO for the EUL.

“This is a sign of a capable leadership. This is the story of Modi ji’s resolve. This is the language of the faith of the countrymen. This is a Diwali of self-reliant India. Thanking @WHO for granting emergency use listing (EUL) to Made-in-India #Covaxin,” he tweeted on Wednesday.

The vaccine was co-developed by the Indian Council of Medical Research (ICMR), which comes under the Union health ministry.

The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation, recommended Covaxin for EUL in its meeting on Wednesday, followed by WHO evaluating Covaxin’s clinical trial data for grant of EUL. The approval came after a request for additional information that the committee sought from Bharat Biotech. It first considered Bharat Biotech’s request for an EUL for Covaxin on October 26.

 

Covaxin was approved for emergency use in India on January 3.
Covaxin was approved for emergency use in India on January 3.

“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 #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used across the planet,” read another tweet by WHO.

Millions of Indians and the government have been watching the process, which was expected to reach some sort of conclusion by the end of October.

Bharat Biotech welcomed the decision.

“The Emergency Use Listing approval by WHO validates the international safety and quality standards of COVAXIN®. Bharat Biotech is motivated to mitigate the worldwide pandemic,” the firm tweeted.

Later, in a statement, it said that countries can now expedite their regulatory approval processes to import and administer Covaxin, and Unicef, pan-American Health Organization (PAHO) and GAVI COVAX facility, will now be able to procure the vaccine for distribution to countries worldwide.

“Validation by WHO is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin. As an organization, we have focused on maintaining stringent quality and safety standards that meet rigorous assessment, and scientific standards established by WHO, as a result, many of our vaccines have received WHO prequalification. 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,” said Krishna Ella, chairman and managing director, Bharat Biotech.

Covaxin was approved for emergency use in India on January 3. Around 10% of the 1.07 billion doses administered so far in the country are of Covaxin.

The grant of EUL will also make the vaccine eligible for distribution to low and middle income countries under the COVAX facility of WHO and GAVI, the vaccine alliance, which aims to make free vaccines available to the poorest countries.

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. Emergency-use listing is a thorough exercise undertaken by WHO and the technical advisory group of independent experts to determine if a manufactured product, in this case Covaxin, is quality-assured, safe and effective or not.

“The TAG gave its recommendations in Covaxin’s favour, and WHO Geneva granted the approval. It was on the expected lines,” said a senior central government official aware of the development, on condition of anonymity.

Earlier, Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which recommended its use in two doses, with a dose interval of four weeks, in all age groups 18 and above.

Bharat Biotech was stuck in a regulatory loop, with independent technical experts of the UN health body taking longer to analyse the data that previously disclosed timelines. WHO’s independent technical advisory group, in its meeting on October 26, sought additional clarifications from the company for Covaxin to conduct a final risk-benefit assessment for Emergency Use Listing of the vaccine.

Bharat Biotech on Friday submitted the additional data that included immunogenicity response in people 60 years and above, and also separately in both men and women.

Earlier, a decision on Covaxin EUL was expected on October 5, after WHO representatives sought additional information on September 27.

Covaxin has shown 77.8% effectiveness against the disease, and 65.2% protection against the new highly transmissible delta variant. Covaxin is an inactivated whole virion vaccine. Countries that recognised Covaxin for travel before WHO EUL include Australia, Mauritius, Iran, Nepal, Oman, Mexico, and Greece.

However, WHO has not recommended Covaxin use in pregnant women, saying more studies are required on the subject.

“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,” WHO said in a tweet.

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Wednesday, December 01, 2021