Home / Companies / News /  Covid-19 vaccine: Bharat Biotech to face delays in introduction in US as FDA rejects EUA

NEW DELHI : Bharat Biotech International would face a delay in introducing its covid-19 vaccine Covaxin into the United States after USFDA’s rejection for its emergency use authorisation (EUA).

Amidst several doubts over its safety and efficacy, the Hyderabad based pharmaceutical company on Friday came into defence of covaxin-- India’s first indigenous covid-19 vaccine—stating that covaxin has received EUA’s from 14 countries with more than 50 countries in the process.

“Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications (BLA) path for covaxin, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for covaxin. This process will extend our timelines," said Bharat Biotech in a statement.

Bharat Biotech said that with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the United States (US). On the side-lines of this, the USFDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new covid-19 vaccines.

“No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Thus, it will be a Great Leap Forward for vaccine innovation and manufacturing from India when approved," said the statement.

The Indian government on Friday said that it respects the USFDA’s decision, however the development will not impact India’s nationwide covid-19 vaccination program under which covaxin is being administered.

"Each country has its own regulatory system. Some parameters might be common while some might be different which we respect. Our country's regulatory system also takes decisions in a similar manner. The scientific framework is the same but nuancing is on context... These are scientific considerations specially in those countries where science is strong and for us manufacturing is strong," said Dr Vinod Paul Member (Health) in NITI Aayog and Chair of the National Expert Group on Vaccine Administration for covid-19 (NEGVAC).

“We expect that our manufacturer will be able to comply with it by doing whatever requires to be done. It will have no impact whatsoever on our programme clearly. We are satisfied our regulator has approved it. We have so much data on safety and so much data on phase-3 trial that has been screened by them," Paul said.

The government said that the phase 3 clinical trial data of Covaxin will also be published and come out in 7-8 days which is beyond data shared with Drugs Controller General of India (DCGI). "We are doing very well. We respect their decision but it will have no bearing on our track at this moment," Paul said.

In April, Bharat Biotech said in a statement that the second interim data from its phase 3 trial of nearly 26,000 participants showed that the vaccine has an efficacy of 78% in preventing covid-19, a tad lower than the 80.6% efficacy found in the first interim data in March.

The covaxin maker also said last month that it expects an emergency use listing for its covid-19 vaccine from the World Health Organization (WHO) in the September quarter.

Covaxin was surrounded by debates among medical fraternity as it was granted an approval for emergency use in India in January with seven weeks into its phase 3 human clinical trials. Covaxin was introduced in the government covid-19 vaccination program under clinical trial mode along with Covishield, the Oxford-AstraZeneca vaccine manufactured by the Serum Institute of India that got EUA by the drug regulator.

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