FDA rejects emergency-use approval of Bharat Biotech's COVAXIN
11 Jun 2021
The United States' top drug regulator - the Food and Drug Administration - has rejected Bharat Biotech's application for an emergency use authorization for its COVID-19 vaccine COVAXIN. The authorities have asked for additional information and data for the vaccine, effectively delaying its potential launch in the US. Bharat Biotech's partner in the US says it would now seek a full approval.
Company says it would now apply for a full approval
The FDA has rejected the approval request as Bharat Biotech had submitted partial trial data from March this year, and data from an additional clinical trial would be required, according to Hindustan Times. Ocugen, Bharat Biotech's partner in the US, said it would skip the emergency use authorization and instead apply for a Biological License Application (BLA) or full approval at a later time.
'Committed to bringing COVAXIN to the US'
"The FDA provided feedback to Ocugen regarding the Master File submitted previously and recommended that we pursue a BLA submission instead of an EUA application for the vaccine candidate and requested additional information and data," Ocugen said in a statement to the New York Stock Exchange. "While this will extend our timelines, we're committed to bringing COVAXIN to the US," the company's CEO said.
COVAXIN is 78% effective against symptomatic disease
COVAXIN is India's only approved indigenous coronavirus vaccine. It is currently one of the three vaccines being used in India's nationwide inoculation program, that began in January. As per an interim analysis, the vaccine was found to be 78% effective against symptomatic COVID-19 disease and 100% effective in providing protection from serious illness.
COVAXIN has not furnished phase-3 trial data yet
The rejection from the US health officials comes at a time when Bharat Biotech is facing criticism in India for failing to share its phase-3 trial data even six months after the vaccine was granted emergency use approval in India. In January, the company had said it would submit results by March, but recently stated the data would be made public only in July.
Many countries do not yet recognize COVAXIN
COVAXIN has been facing troubles securing approvals in foreign countries and from the World Health Organization (WHO). International recognition is essential for the company to start widely exporting its vaccine and become part of the "vaccine passport" - under which fully vaccinated people would be allowed to travel abroad. Countries that have approved the jab include Iran, Philippines, Mauritius, Mexico, Nepal, Guyana, and Zimbabwe.
US universities ask students who took COVAXIN to get re-vaccinated
In fact, universities across the US are asking foreign students to get re-vaccinated if they have been inoculated with vaccines that don't yet have the approval from the WHO. This includes Indian students who may have taken COVAXIN or the Russian vaccine Sputnik V's shots.