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WHO issues EUL for Covaxin to boost global acceptability

Move to ease international travel opportunities for those inoculated with the vaccine
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G.S. Mudur   |   New Delhi   |   Published 04.11.21, 02:19 AM

The World Health Organisation on Wednesday issued an “emergency use listing” for Covaxin that could boost the global acceptability of India’s home-grown Covid-19 vaccine and expand international travel opportunities for those inoculated with it.

The WHO approval follows an assessment procedure by its technical advisory group (TAG), which scrutinised the vaccine’s quality, safety and efficacy on the basis of data furnished since early July by the manufacturer, Bharat Biotech.

Covaxin is the eighth Covid-19 vaccine in the world to receive an emergency use listing (EUL) from the WHO after vaccines from Pfizer-BioNTech, Oxford-AstraZeneca, Serum Institute of India, Moderna, Johnson & Johnson and the Chinese companies Sinopharm and Sinovac.

“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” Mariangela Simao, WHO assistant director-general for access to medicines and health products, said in a statement on Wednesday.

An emergency use listing from the WHO is a prerequisite for vaccine supply through Covax, an international facility that makes vaccines available to poor countries and allows nations to speed up their own regulatory approval to importing and administering Covid-19 vaccines.

The EUL will also expand travel opportunities for Covaxin recipients into countries that recognise vaccines approved by the WHO. The US has, for instance, decided to allow entry to people inoculated with vaccines that include those that have approval from the US Food and Drug Administration or an EUL from the WHO.

The TAG convened by the WHO and made up of regulatory experts from around the world has determined that Covaxin meets the WHO standards for protection against Covid-19, that its benefit far outweighs its risks, and that it can be used globally, the WHO said.

The WHO’s strategic advisory group of experts on immunisation too had last month reviewed data on Covaxin and recommended its use in adults. Covaxin has 78 per cent efficacy against Covid-19 of any severity 14 or more days after the second dose.

The WHO has, however, said the available data on the inoculation of pregnant women with Covaxin is “insufficient to assess vaccine safety or efficacy in pregnancy”. Studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.

Experts familiar with the EUL procedure said the near four months taken to evaluate Covaxin should not be considered unusually long because any home-grown vaccine from India is likely to encounter tougher scrutiny than vaccines approved in the US or Europe.

A WHO document outlining the assessment pathways for EUL indicates that vaccines already approved by stringent regulatory authorities — such as those in Canada, European Union, Britain or the US — may undergo an “abridged assessment” based on the reports from those authorities.

Although India’s Central Drugs Standard Control Organisation had approved Covaxin in early January, the CDSCO is not classified as a stringent regulatory authority.

“Under these circumstances, the assessment of any vaccine from India is likely to be more detailed than that for vaccines already approved in the US or Europe,” an expert said.



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