In a setback to Bharat Biotech, the United States top public health regulator, Federal Drug Administration (FDA), has not given approval for emergency use authorisation (EUA) to COVID-19 vaccine Covaxin. Bharat Biotech’s US partner Ocugen Inc said that the company will now week the Biologics Licence Application (BLA) route for made-in-India Covaxin. BLA means seeking full US approval of the indigenous vaccine candidate Covaxin, without pursuing an emergency use authorisation. This means that ‘additional information and data,’ presumably relating to human clinical trials, safety and immunogenicity, will need to be submitted.
Why was Covaxin rejected by the Food and Drug Administration (FDA)?
According to media reports, USFDA rejected Bharat Biotech’s proposal for emergency use approval of Covaxin, the Covid-19 vaccine, in the US because the company submitted partial trial data from March this year. The made-in-India vaccine has been facing criticism back home in India for not sharing its Phase-3 clinical trials data, despite being approved by the Drugs Controller General of India (DCGI) for vaccination in India in early January.
As per reports, the US top public health regulator has asked Ocugen to submit additional trial data so that it can file for a Biologics Licence Application (BLA), which is a full approval, instead of the emergency use approval
USFDA gives emergency use authorisation to these vaccines
US FDA has already granted EUAs to Pfizer, Moderna Inc and Johnson & Johnson, secured far more doses than required to fully vaccinate its population and has even signalled its intention to begin exporting doses to other countries.
Meanwhile, the Hyderabad-based company has specified that Covaxin has received EUA’s from 14 countries with more than 50 countries in the process.
Covaxin’s lack of Phase-3 trial data
Bharat Biotech, which is currently carrying out the Phase-3 clinical trials for Covaxin will make the data public during July, The phase-3 trial data is crucial for the company to seek emergency approval from the World Health Organization (WHO), which will in turn allow the company to export its vaccines. Besides, it will also grant the company’s vaccine the much-needed validation required to be considered a part of “vaccine passport”.
How the USFDA decision impacts COVAXIN beneficiaries?
It will have implications on people who have taken Covaxin shots and have plans to travel abroad, especially to the US. And, also in the absence of a WHO approval, it is very likely that many countries will treat people vaccinated with Covaxin as unvaccinated.