Bharat Biotech's Covaxin gets WHO approval for Emergency Use Listing

Covaxin was reviewed by WHO's Strategic Advisory Group of Experts on Immunization, and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above

The World Health Organisation (WHO) on Wednesday said it had approved Indian drugmaker Bharat Biotech's COVID-19 vaccine for emergency use, paving the way for the homegrown shot to be accepted as a valid vaccine in many poor countries.

The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status for Covaxin. 

"Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that Covaxin vaccine meets WHO standards for protection against COVID, that benefit of the vaccine far outweighs risks and the vaccine can be used across the world," said WHO

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

Available data on vaccination of pregnant women with the Covaxin 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, said WHO.

The TAG on October 26 had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.

The 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.

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

In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

The emergency use listing would allow Bharat Biotech to ship the vaccine to countries that rely on WHO guidance for their regulatory decisions.

Covaxin is the seventh to win WHO backing following two mRNA shots by Pfizer/BioNTech and Moderna, adenovirus vector vaccines developed by AstraZeneca and Johnson & Johnson, and China's inactivated vaccines from Sinovac Biotech and Sinopharm.

The nod also mean that the shot may be accepted as a valid vaccine for millions of Indians who have received it and want to travel outside the country.

Oman last week and Australia on Monday said they will recognise Covaxin as a valid vaccine for travellers.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield, manufactured by Serum Institute in Pune, are the two widely used vaccines in India.

Dr Poonam Khetarpal Singh, Regional Director of WHO South East Asia, in a tweet, said, "Congratulations India for Emergency Use Listing of its indigenously produced COVID-19 vaccine Covaxin." "The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin," a source told PTI before the WHO announcement.

Prime Minister Narendra Modi met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit recently.

Meanwhile, Bharat Biotech on Wednesday 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.

"The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf life extension is based on the availability of additional stability data, which was submitted to CDSCO," Bharat Biotech said in a tweet.

The shelf life extension has been communicated to "our stakeholders," it added.