Bharat Biotech to hold Covaxin pre-submission meeting with WHO next Wednesday
Hyderabad-based vaccine manufacturer Bharat Biotech will hold its pre-submission meeting with the World Health Organization (WHO) next Wednesday, i.e. on June 23 regarding the approval of Covaxin, its India-made Covid-19 vaccine, reported news agency ANI after reviewing a WHO document. The pharmaceutical company has been facing hurdles in getting Covaxin approved in some foreign countries since it lacks Phase-3 trial data, which is essential for a WHO nod to export the vaccine and make it a part of the much-coveted coronavirus "vaccine passport".
Bharat Biotech had earlier told ANI that it will make Covaxin's Phase-3 trial data public during July, following which the company will be applying for full licensure of the Covid-19 vaccine in India. It added that Phase-4 trials are also being done to check the "real-world effectiveness" of the vaccines" and to meet scientifically approved standards for safety and efficacy. Currently, the vaccine has been granted authorisation for emergency use by the Drugs Controller General of India (DCGI), India's foremost drug regulator.
The United States' top health regulator -- the Food and Drug Administration (FDA) - recently rejected Covaxin's application for emergency use authorisation, citing the lack of data on clinical trials, putting more hurdles on Covaxin's path to gaining foreign approvals at a time when vaccine access continues to be scrutinized in strictly regulated markets. t a time when authorisation from top health regulators at the US, the European Union, or the WHO is needed for a vaccine to cross borders, the India-made Covid-19 vaccine Covaxin remains unrecognised, as some foreign countries are even considering Indian students vaccinated with Covaxin as "unvaccinated".
The company has so far invested at least ₹500 crore at risk from its own resources for product development, clinical trials, and setting up manufacturing facilities for Covaxin. At least 40 million doses of Covaxin have been supplied in India to date, as per the company, and product development activities towards the development of vaccines against newer variants are also underway at their facilities.