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June 18, 2021

FDA declines emergency use of Covaxin

United States Food and Drugs Administration (FDA) has declined the emergency use of Covaxin developed by Bharat Biotech. Covaxin is an India-made vaccine developed by Bharat Biotech against the Coronavirus disease. The vaccine has been developed by using ‘whole-Virion Inactivated Vero Cell’.

The decision to reject the emergency use of Covaxin has been taken due to the limited amount of data and information provided by Bharat Biotech. FDA requires extra clinical test data for supporting the marketing application submission for Covaxin. Additional information and data from human clinical trials, the vaccine’s safety, and acceptable efficacy must be provided to the FDA. US FDA said that the corporate would need to follow the biological license application process for vaccines. Ocugen, Bharat Biotech’s US partner, said they would pursue to urge complete approval of Covaxin. The FDA has asked Ocugen to start with their additional vaccine trial so that the corporate can file for a Biologics Licence Application (BLA). The BLA grants complete approval to the vaccine. Ocugen, as per the instructions given by FDA, will file a BLA to urge complete approval for Covaxin. Ocugen said on 10 June, the corporate won’t attempt to get the emergency approval for Covaxin. Instead, it will try to provide all the knowledge and data asked by US FDA. The information from the Phase-3 trial of Covaxin is going to be released publicly in July. Bharat Biotech will apply for complete approval of Covaxin only after releasing the entire data and knowledge. ” While this may extend our timelines, we are committed to bringing Covaxin to the US,” Dr Shankar Musunuri, Chairman of the Board, CEO and co-founder of Ocugen, said.

What does it mean for India?

The US FDA has directed Bharat Biotech to apply for a BLA for a full licence for Covaxin. The corporate has responded positively and agreed to provide complete information and data about the vaccine. But this will create a sort of hesitation among people. Already, nearly 70 per cent of Indians are unwilling to get the COVID-19 vaccine due to misconceptions created by oppositions. However, the Centre has said that the FDA turning down Covaxin isn’t going to disturb India’s vaccination drive. VK Paul, a member of NITI Aayog, said that “Certain vaccines vary as per scientific consideration like nutrition, genetic dynamic consideration. We respect FDA’s decision and we expect that our manufacturers will comply with whatever it requires to be done. Each country has its own regulatory system, some parameters could be common, some could be different. We are satisfied our regulator approved it”, he further added. He said that the Phase-3 trial data of the vaccine is going to be published in a peer-reviewed journal.

Bharat Biotech said, “With good heard immunity and significant percentage of the population vaccinated, the pandemic in US is reducing. Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications path for Covaxin, which is full approval instead of EUA.” Responding to FDA’s denial of emergency Covaxin use, the government said that America’s decision won’t affect India. India will still use the vaccine.

The most immediate impact of the decline in emergency use of Covaxin will be that it will delay plans of rolling out the vaccine in the US. The method of application for BLA and additional clinical test of the vaccine will be time-consuming. FDA’s decision of declining the emergency use of Covaxin may delay the target of vaccinating the entirety of India as early as possible.

Vaccine certificates or passports are becoming a reality as countries are opening their borders only for fully vaccinated individuals. It’s crucial to supply all the extra data and knowledge to FDA to urge complete approval for Covaxin.


With inputs from Indian Express and LiveMint

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