The World Health Organization (WHO) may give its nod to India Biotech’s Covid-19 vaccine Covaxin this week, news agency years Reported on Monday.
The domestic vaccine is yet to get approval from the international health body, which India has been pushing since launching its vaccination campaign in January this year.
business today A report on September 1 said a WHO panel would convene in the week to assess the application of Covaxin for the Emergency Use List, which would allow individuals immunized with Bharat Biotech’s vaccine to travel freely.
The WHO panel will evaluate Covaxin’s immunogenicity, vaccine safety and vaccine effectiveness, the report said, adding that a certification from the body would allow Bharat Biotech to export Covaxin, for those patients traveling internationally. It will be easier for those who have received the vaccine.
Covaxin will be subject to an in-depth review of clinical trial data as well as supplemental data on safety, efficacy, quality, and risk management strategy.
The domestic company had submitted its Phase III clinical trial data to the subject expert committee of the Central Drugs Standard Control Organization (CDSCO) demonstrating 77.8 per cent efficacy. A pre-submission meeting was held for the EUL in June to provide guidance and support prior to the submission of the final dossier.
In July, the government informed parliament that it had submitted the documents required for the EUL, which usually takes up to six weeks for the WHO to decide.
Earlier this month, the WHO’s assistant director general for vaccines, Mariangela Simao, said the UN health agency’s evaluation of the India biotech vaccine was “very advanced”, with officials expecting 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, called Covishield, manufactured by the Serum Institute of India, were the two options that were initially made available to the Indian public at the start of the vaccination campaign.
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