Covaxin emergency use: WHO seeks ‘additional clarifications’ from Bharat Biotech
The global health body’s technical advisory group will meet again on November 3 if they receive data from the Indian company.
The World Health Organization’s technical advisory group on Tuesday sought “additional clarifications” from India’s Bharat Biotech to conduct a final risk-benefit assessment for an emergency use listing of Covaxin.
The group will meet again on November 3 to consider the company’s request for an emergency listing if they receive data soon, the global health body’s chief scientist Soumya Swaminathan said in a tweet.
The World Health Organization told PTI that the technical advisory group was expecting to receive the information from the Hyderabad-based vaccine manufacturer by the end of the week.
Update: The @WHO independent TAG met today & asked for addnl clarifications from the manufacturer @BharatBiotech to conduct a final EUL risk-benefit assessment for global use of #Covaxin. It will reconvene for the final assessment on Wednesday, 3 November if data received soon
— Soumya Swaminathan (@doctorsoumya) October 26, 2021
Earlier on Tuesday, the World Health Organization’s spokesperson Margaret Harris told journalists at a United Nation press briefing that if “all goes well”, then Covaxin might get approval within 24 hours.
India had applied to the World Health Organization for emergency use listing for Covaxin in April.
Emergency use listing is a procedure by the global health body to approve vaccines and other products for use during public health emergencies. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer.
On October 18, the World Health Organization had said that it cannot “cut corners” in deciding to recommend Covaxin for an emergency use listing
Last month, the World Health Organization had said that Bharat Biotech began submitting “rolling data” on July 6. In a rolling review, the global health body can analyse information when it comes in from an applicant, thus accelerating the process.
So far, the World Health Organization has approved six vaccines from Pfizer, Johnson & Johnson, AstraZeneca-Oxford, Moderna, Sinopharm, and Sinovac.
The Drugs Controller General of India had granted approval for restricted emergency use to Covaxin in January. Covaxin and Oxford-AstraZeneca’s Covishield were the first Covid-19 vaccines to be approved in India.
