Covaxin to be evaluated as Covid-19 vaccine candidate in US as USFDA lifts clinical hold

Bharat Biotech on Saturday said its Covaxin will be evaluated as a Covid-19 vaccine candidate in the US.

In a statement, Ocugen Inc, Bharat Biotech's partner in the US and Canada for Covaxin, noted that the American health regulator -- the US Food and Drug Administration (FDA) -- has lifted its clinical hold to evaluate the Covid-19 vaccine candidate BBV152, known as Covaxin outside the US.

Covaxin (BBVI52), which has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is an investigational vaccine candidate product in the US.

Ocugen Inc is co-developing the Covaxin vaccine candidate for Covid-19 in the US and Canada.

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"We are pleased to be able to move our clinical program for Covaxin forward, which we hope will bring us closer to offering an alternative Covid-19 vaccine," Ocugen CEO and co-founder Shankar Musunuri said in a statement.

He further said: “We firmly believe that managing this pandemic requires more than one approach to vaccines, so we are heartened to be able to continue developing our vaccine candidate."

With more than 200 million doses having been administered to adults outside the US, Covaxin is currently authorised under emergency use in 20 countries.

Applications for emergency use authorisation are pending in more than 60 other countries.

The World Health Organisation (WHO) recently added Covaxin to its list of vaccines authorised for emergency use. As many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using Covaxin.

In a separate statement on Twitter, Bharat Biotech noted that Covaxin is the only vaccine in India to have published clinical data for children 2-18 years of age, while trashing few media reports which questioned the efficacy of the jab.

These trials were conducted based on regulatory approvals by the CDSCO and DCGI, it said.

The vaccine was evaluated in 175 subjects in the 12-18 years age group, and 350 subjects in children below 12 years of age, it added.

"It was one of the few vaccines to be evaluated in children with published data. Overall, Covaxin has more than 15 publications elucidating all aspects of the safety, immunogenicity, efficacy and effectiveness, in adults and children. This level of data transparency demonstrates a high degree of confidence in the product," the company stated.

Every batch of Covaxin requires more than 250 quality control tests before it can be released for supplies, it added. The vaccine has been administered in more than 300 million subjects globally, Bharat Biotech stated.

"Since the start of the children's vaccination program on January 3, 2022, 70 per cent of the children in the 15-18 years age group have received the first dose, and more than 25 per cent of the children in the 15-18 years age group have also received their second doses," it said.

Over 7 crore doses have been administered to children since January 2022, it added.

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