Following a review of a WHO document, Hyderabad-based vaccine manufacturer Bharat Biotech will hold a pre-submission meeting with the World Health Organization (WHO) next Wednesday, June 23, to discuss the approval of Covaxin, its India-made Covid-19 vaccine. Because it lacks Phase-3 trial data, which is required for a WHO nod to export the vaccine and make it a part of the much-coveted coronavirus “vaccine passport,” the pharmaceutical company has had difficulty getting Covaxin approved in some foreign countries.
Bharat Biotech had previously told that Covaxin’s Phase-3 trial data would be made public in July, and that the company would then apply for full licensure of the Covid-19 vaccine in India. Phase-4 trials are also being conducted to assess the vaccines’ “real-world effectiveness” and to ensure that they meet scientifically approved safety and efficacy standards. The vaccine has currently been approved for emergency use by India’s top drug regulator, the Drugs Controller General of India (DCGI).
The Food and Drug Administration (FDA), the United States’ top health regulator, recently rejected Covaxin’s application for emergency use authorisation, citing a lack of data from clinical trials, adding to Covaxin’s path to gaining foreign approvals at a time when vaccine access is still being scrutinised in tightly regulated markets. The India-made Covid-19 vaccine Covaxin remains unrecognised at a time when top health regulators in the US, the European Union, or the WHO are required for a vaccine to cross borders, and some foreign countries are even considering Indian students vaccinated with Covaxin as “unvaccinated.”
