WHO approves Bharat Biotech's Covaxin for Emergency Use Listing

Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant

The World Health Organization (WHO) on Wednesday approved an Emergency Use Listing (EUL) for India’s home-grown Covid shot, Covaxin, manufactured by Bharat Biotech, adding to a growing portfolio of Covid-19 vaccines validated by the WHO.

The nod will pave the way for Indians receiving Covaxin to travel freely all over the world besides opening up the doors for export and manufacturing of the Indian vaccine in other countries through the technology transfer route.

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“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products.

In a statement issued in July after it approached the WHO for granting the EUL, the Hyderabad-based company claimed the vaccine to be 77.8% effective against symptomatic Covid-19 and 93.4% effective against severe symptomatic Covid-19. In addition, the efficacy data demonstrated 65% protection against the Delta variant.

Developed in partnership with the National Institute of Virology, Pune that isolated the vaccine strain, the vaccine has so far been administered to more than 12 crore Indians. But the absence of the WHO certification was a bottleneck for such persons undertaking international travel as the majority of the countries didn’t recognise the vaccine.

Agencies like UNICEF, Pan-American Health Organization (PAHO), GAVI COVAX facility couldn’t procure it for distribution in other countries.

“The WHO validation is a very significant step towards ensuring global access to India’s widely administered, safe, and efficacious Covaxin,” Krishna Ella, Chairman and Managing Director, Bharat Biotech, said in a statement.

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Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. The world health body adopted a different approach reserved for countries with less stringent regulatory systems.

The assessment process began on July 6 when Bharat Biotech made the official request for the EUL following a successful phase-3 trial.

Covishield, the other vaccine used in India received WHO approval in February as it is identical to the AstraZeneca-Oxford vaccine used extensively in the UK.

After a four-month-long process, the Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, determined that the vaccine met the WHO standards for protection against Covid-19 and could be used globally as the benefits far outweighed the risks.

The indigenous shot was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunisation, which formulates vaccine specific policies and recommendations for vaccines’ use in populations.

The SAGE recommended the use of the vaccine in two doses, with a dosing interval of four weeks, in all age groups 18 and above. Covaxin was found to have 78% efficacy against Covid-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements.

The use of the vaccine on pregnant women was also recommended based on the risk-benefit analysis as clinical data on vaccination of pregnant women were insufficient.

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