Bharat Biotech expects WHO emergency listing for Covaxin in July-Sept
Premium- Application for EUL has been submitted to WHO-Geneva. Regulatory approvals are expected Jul-Sept 2021, Bharat Biotech said
Bharat Biotech International on Tuesday said that it has submitted its application for an emergency use listing for its covid-19 to the World Health Organization (WHO) and expects a clearance from the Geneva-based agency in July-September.
“Application for EUL has been submitted to WHO-Geneva. Regulatory approvals are expected Jul-Sept 2021," the Hyderabad-based vaccine maker said in a statement.
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On Monday, while citing a WHO document, Mint reported that Bharat Biotech International may hold a preliminary meeting with the World Health Organization (WHO) this month or the next before applying for an emergency-use listing (EUL) for its covid vaccine, Covaxin.
While Bharat Biotech had submitted its expression of interest for Covaxin’s EUL to the WHO on 19 April, it is not clear if the company has made its final submission yet. A reply from the company’s spokesperson was not immediately available.
In its statement on Tuesday, Bharat Biotech also said that it is in the process of seeking regulatory authorisation in over 60 countries, including the US, Brazil and Hungary.
Bharat Biotech has already obtained clearances for Covaxin from regulators in 13 countries, including Mexico, Philippines, Iran, Paraguay, Zimbabwe, among others.
The statement follows reports that the European Union (EU) is considering allowing entry for non-essential travel to people who have been fully vaccinated using jabs that have been approved by the European Medicines Agency (EMA) or have a WHO EUL.
While WHO and EMA have authorized vaccines from Pfizer, Moderna, AstraZeneca and Johnson & Johnson, WHO has also included jabs from China’s Sinopharm in its list.
After the company submits its final proposal for Covaxin’s EUL, WHO’s product evaluation group comprising of regulatory experts from around the world and a technical advisory group will conduct a review. The process may include on-site inspections of the company’s facilities.
Last month, Bharat Biotech had issued a statement saying that the second interim data from its phase 3 trial of nearly 26,000 participants showed that the vaccine has an efficacy of 78% in preventing covid-19, which was partially lower than the 80.6% found in the first interim data in March.
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