WHO finally gives emergency use nod for Covaxin

Those administered indigenous Indian vaccine against COVID-19 can now travel abroad unhindred 

By Vibha Varshney
Published: Wednesday 03 November 2021

The World Health Organization finally granted an emergency use listing (EUL) to Covaxin, India’s indigenous vaccine against the novel coronavirus (SARS-CoV-2). It was developed by Bharat Biotech International Ltd (BBIL), using the virus sequence provided by Indian Council of Medical Research’s National Institute of Virology.

With the EUL, Covaxin will be recognised by WHO member countries; those administered the vaccine — most of whom are in India — will be able to travel across the world. At present, they can travel only after getting a negative RT-PCR [Reverse transcription polymerase chain reaction] test and then quarantining for days after reaching their destinations.

WHO has a five-step process to approve vaccines for emergency use. For Covaxin, the process started April 16, 2021. The assessment continued for more than 6 months before the Technical Advisory Group for Emergency Use Listing gave a go-ahead November 3.

Covaxin was approved by WHO’s Strategic Advisory Group of Experts on Immunization for use in people over 18, the global body posted on microblogging website Twitter. Two doses of the vaccine are to be given at an interval of four weeks.

The United Nations arm, however, indicated that data on vaccination of pregnant women with Covaxin was insufficient to assess safety or efficacy; further studies are planned.

BBIL had claimed that Covaxin is 78 per cent effective against the novel coronavirus disease (COVID-19) of any severity, 14 or more days after the second dose. WHO tweeted that it found the vaccine extremely suitable for low- and middle-income countries due to easy storage requirements.

With Covaxin, seven vaccines (eight if the two from Oxford-AstraZeneca Plc are not clubbed together) have been approved for use globally.

India had approved Covaxin way back in January and included it into the national vaccination plan for COVID-19. AstraZeneca’s vaccine Covishield, manufactured by Serum Institute of India too had received a go-ahead at the same time. Neither vaccines had completed their Phase 3 trials. 

The approval puts at rest fears regarding the safety and efficacy of the vaccine. Last week, in response to a plea to allow people vaccinated with Covaxin to receive two additional doses of Covishield, the Supreme Court had decided to withhold the decision till after Diwali. 

The approval came the day Prime Minister Narendra Modi launched the Har Ghar Dastak campaign to accelerate vaccination in the country, especially in rural areas. A total of 1,072,966,315 vaccine doses have been administered in the country. These includes Covaxin, Covishield and Sputnik V vaccines. 

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