Covaxin, Bharat Biotech's COVID-19 vaccine, expected to get WHO nod this week: Report
New Delhi | Jagran News Desk: The World Health Organisation's nod for Bharat Biotech's COVID-19 vaccine, Covaxin is expected to come this week, according to news agency ANI. The indigenous vaccine is manufactured by Hyderabad-based pharmaceutical company Bharat Biotech.
The biotechnology company 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 before the submission of the final dossier.
It was in July that the government had said in parliament that it has submitted all documents required for Emergency Use Listing (EUL). WHO usually takes up to six weeks to decide on EUL submissions.
"EUL is a prerequisite for COVAX Facility vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines," mentions the WHO's official website.
"The EUL assesses the quality, safety, and efficacy of COVID-19 vaccines, as well as risk management plans and programmatic suitability, such as cold chain requirements. The assessment is performed by the product evaluation group, composed of regulatory experts from around the world and a Technical Advisory Group (TAG), in charge of performing the risk-benefit assessment for an independent recommendation on whether a vaccine can be listed for emergency use and, if so, under which conditions," it further adds.
Earlier this month, WHO Assistant Director-General for vaccines Mariangela Simao had said that the UN health agency's assessment of the Bharat Biotech vaccine was "quite advanced" and officials hoped for a decision by mid-September.
Meanwhile, 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 Covishield were the two options initially made available to the Indian public at the start of the inoculation drive.
Posted By: Sugandha Jha