WHO nod likely for Covaxin this week

Tribune News Service

New Delhi, September 13

India’s first indigenous Covid-19 vaccine Covaxin is likely to receive WHO approval for emergency use listing (EUL) this week.

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Sources in the government indicated that the process of WHO approval was “in the final stages”. Bharat Biotech had on July 3 announced Phase 3 trial results of Covaxin, showing the vaccine to be 78 per cent effective against the overall Covid disease and 93 per cent effective against severe infections.

75 cr doses given

As India crossed the milestone of administering 75 crore Covid vaccine doses nationally, the WHO congratulated India for scaling up the vaccination drive at an “unprecedented pace”.

Inclusion process

For any vaccine to be included in the WHO EUL, the manufacturing firm should have completed Phase 3 trials and submitted its entire data to the regulatory department of the WHO, which then examines the application.

The safety and efficacy analysis data from Phase 3 clinical trials of Covaxin, developed in partnership with the ICMR-National Institute of Virology Pune, revealed that the vaccine significantly cut hospitalisations and showed potential to limit infection and transmission. The data was submitted to the national regulatory authority and also to the WHO, which assesses safety, immunogenicity and efficacy of vaccines before notifying these in the EUL.

Such EUL would enable Indians inoculated with Covaxin to travel abroad without restrictions. Soumya Swaminathan, chief scientist of the WHO, had said on July 9 that the EUL for Covaxin was close. “The EUL can come within 4 to 6 weeks,” Swaminathan had said on July 9.

Importantly, Prime Minister Narendra Modi, who has been inoculated with Covaxin, will be in the United States on September 25 to address the UN General Assembly.

For any vaccine to be included in the WHO EUL, the manufacturing firm should have completed Phase 3 trials and submitted its entire data to the regulatory department of the WHO, which then examines the application.

The World Health Organisation EUL currently includes six vaccines — Pfizer/BioNTech, Astrazeneca/Serum Institute of India, AstraZeneca EU, Johnson and Johnson’s Janssen, Moderna and Chinese Sinopharm.