Intended for healthcare professionals


Covid-19: WHO suspends supplies of India’s Covaxin through UN agencies

BMJ 2022; 377 doi: (Published 06 April 2022) Cite this as: BMJ 2022;377:o902
  1. Kamala Thiagarajan
  1. Tamil Nadu

The World Health Organization has suspended the supply of Covaxin through UN procurement agencies because of manufacturing irregularities. Covaxin is India’s indigenous covid-19 vaccine, produced by the Hyderabad based Bharat Biotech.

A spokesperson for WHO told The BMJ that the suspension had come after a broader inspection of a few companies in India by the agency.

“In the case of Bharat Biotech’s Covaxin manufacturing site, problems were detected in some parts of the manufacturing process, and changes were made after the emergency use listing was granted,” said the spokesperson. “But [these] were not submitted to the national drug regulator and WHO for evaluation and validation. However, the company is fully aware and cooperative.”

The move came a day after Bharat Biotech announced that it would be scaling down its production of Covaxin domestically, as demand was dropping and infections were reducing alongside wider immunisation coverage in India. Covaxin received emergency use authorisation from India’s Central Drugs Standard Control Organization in January 2021 and was included in the nationwide immunisation drive.

Just 288 million of the 1.8 billion vaccine doses administered in India since January 2020 have been Covaxin. Most of the rest were AstraZeneca’s Covishield, although 1.2 million doses of Russia’s Sputnik V have also been administered in India.1

WHO said that its decision to suspend the procurement of Covaxin by UN agencies would allow the manufacturer to upgrade facilities and deal with the deficiencies found in the inspection. Bharat Biotech did not respond to requests for comment.

Younger age groups

Separately, scientists in India have raised concerns about the restricted emergency use authorisation of Biological E’s Corbevax vaccine on 21 February for adolescents aged 12 to 18, which they say was done without any trial data being published.2

The biotech and pharmaceutical company, based in Hyderabad, is the first Indian company to be authorised to receive mRNA vaccine technology from WHO. Corbevax was authorised for use in adults in December 2021 and is India’s third homegrown vaccine, but its use is being restricted to 12 to 18 year olds.

Nearly 50 million children are set to receive Corbevax in an immunisation drive that started last month, as public and private schools reopen around the country after nearly two years of covid related shutdowns.

Gagandeep Kang, virologist and professor of gastrointestinal sciences at the Christian Medical College in Vellore, India, told The BMJ, “With all vaccines intended for use in all ages, it would be best to generate substantial post-approval safety data in adults before moving the vaccine into younger age groups.

“In general, protein vaccines are safe, and I assume that the government decision to begin to use Corbevax is based on two factors: first, that the vaccine is licensed for primary immunisation and there is not a substantial number of adults to immunise with a primary series; and second, that it is a protein vaccine that has met the criteria for safety and immunogenicity laid down by the Indian regulators.”

This article is made freely available for personal use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.