The World Health Organisation (WHO) has sought more information from Bharat Biotech on its emergency use listing application for the company’s Covid vaccine Covaxin, according to information provided on the UN health agency's website.
Bharat Biotech submitted its application to the WHO for the listing on April 19.
The Hyderabad-based pharmaceuticals company will hold a meeting with WHO in May or June on the issue. After the meeting, the application will go through three stages for review before the approval.
The WHO’s approval will pave the way for other countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the other organisations to procure the vaccine for distribution to countries in need.
Both WHO director general Dr Tedros Adhanom Ghebreyesus and chief scientist Soumya Swaminathan have already stated that Indian vaccines are both safe and effective against Covid-19 and want India to contribute more to the COVAX programme which supplies vaccines to poor countries.
WHO has already listed the AstraZeneca-Oxford vaccine, which is also produced locally by the Pune-based Serum Institute of India for emergency use .
Pfizer-BioNTech. Moderna, Johnson & Johnson and China’s Sinopharm have also been approved for emergency listing.
Bharat Biotech is currently producing 10 million doses of the vaccine a month and is planning to ramp up its production by an additional 200 million doses at Ankleshwar, Gujarat where production will start in Jan-March quarter.
Bharat Biotech is planning Covaxin trials for 2-18 age group from June. The company said it will be ramping up the manufacturing capacity to 700 million doses by the end of this year. It also started a trial of a third booster dose of the vaccine on Monday at AIIMS, Delhi and AIIMS, Patna.
The emergency use listing (EUL) process requires an assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
