Available data on vaccination of pregnant women with Covaxin are insufficient to assess vaccine safety: WHO

Even as the World Health Organisation on Wednesday granted emergency use listing (EUL) to Bharat Biotech's COVID-19 vaccine Covaxin. This comes after the Technical Advisory Group (TAG), an independent advisory committee of WHO recommended EUL status for Covaxin.

However, the global health body said that the available data on vaccination of pregnant women with the Covaxin are insufficient to assess vaccine safety or efficacy in pregnancy. "The studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry," WHO added.

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.

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.

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

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.

Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.

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