Covaxin data on pregnant women is not enough: WHO

The World Health Organization (WHO), while granting emergency use listing to Covaxin on Wednesday, however, said available data on use of Bharat Biotech's Covid vaccine on pregnant women is "insufficient to assess safety or efficacy". The WHO also did not make any recommendation for its use in children. India had allowed Covid vaccines for pregnant in July this year. The subject expert committee did not accept Bharat Biotech's proposal to allow use of Covaxin in pregnant women in its meeting in June.

The government gave its nod to give the vaccine to pregnant women next month based on a recommendation from National Technical Advisory Group on immunisation (NTAGI), people aware of the matter said.

The decision appears to have been taken by Negvac (National Expert Group on Vaccine Administration for Covid-19) and NTAGI governmental committees, bypassing the CDSCO (Central Drugs Standard Control Organisation, the country's drug regulatory body) process, said Malini Aisola, co-convenor at All India Drugs Action Network.


"There is a record of the SEC asking for additional safety data on June 22 in reference to extending the use of Covaxin for pregnant women. There is no further record of SEC granting permission for use of Covaxin (or Covishield) in pregnancy or any accompanying conditions," she told ET.

"Unfortunately, NTAGI's specific recommendations that offering vaccination in pregnancy should be accompanied by studies to monitor the safety and effectiveness of the Covid-19 vaccines in pregnant women were ignored and never implemented," Aisola alleged. "As far as we know, there was also no discussion whatsoever regarding the appropriate timing in pregnancy for giving these vaccines, whereas countries around the world have formulated guidelines on timing that vary based on expert deliberations and the data on the available vaccines," she said.