The World Health Organization (WHO) is likely to give its approval to Bharat Biotech’s Covid-19 vaccine Covaxin this week, news agency ANI reported on Monday.
The homegrown vaccine has yet to receive a nod from the international health body, which India has been pushing for since the country started its vaccination drive in January this year.
Business Today in a report on September 1 had said a WHO panel would convene in the week to assess Covaxin’s application for emergency use listing, which will allow persons immunised with Bharat Biotech’s vaccine to travel freely.
The WHO panel will evaluate Covaxin’s immunogenicity, vaccine safety, and vaccine effectiveness, the report had said, adding that a certification from the body will also allow Bharat Biotech to export Covaxin, making it easier for patients who have received the vaccine to travel internationally.
Covaxin will be subjected to a thorough review of clinical trial data as well as supplementary data on safety, efficacy, quality, and risk management strategy.
The homegrown company had submitted its Phase 3 clinical trials data that demonstrated 77.8 per cent efficacy to the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO). A pre-submission meeting for EUL was held in June, providing guidance and assistance prior to the submission of the final dossier.
In July, the government had informed the Parliament that it had submitted the necessary documentation for EUL, which the WHO typically takes up to six weeks to make a decision on.
Earlier this month, Mariangela Simao, WHO Assistant Director-General for Vaccines, stated that the UN health agency’s evaluation of the Bharat Biotech vaccine was “very advanced," with authorities hoping for a decision by mid-September.
Pfizer-BioNTech, AstraZeneca-SK Bio or Serum Institute of India, Johnson & Johnson, Moderna, and Sinopharm have all received WHO approval for COVID-19 vaccines. Covaxin, and AstraZeneca’s vaccine produced by the Serum Institute of India, dubbed Covishield, were the two options initially made available to the Indian public at the start of the inoculation drive.