Covaxin To Be Evaluated As Covid-19 Vaccine Candidate In US: Bharat Biotech

Covaxin (BBVI52), developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR), is a vaccine candidate currently under evaluation in the United States.

Representational Image. (Source: Getty Images)

New Delhi: Bharat Biotech announced on Saturday that its Covaxin would be assessed in the United States as a COVID-19 vaccine candidate.

Ocugen Inc, Bharat Biotech's US and Canadian partner for Covaxin, said in a statement that the American health authority, the US Food and Drug Administration (FDA), has withdrawn its clinical hold to study the COVID-19 vaccine candidate BBV152, known as Covaxin outside the US, PTI reported.

COVAXINⓇ will be evaluated as a COVID-19 vaccine candidate in the United States. #COVID19 #COVAXIN #VaccineMandate #BharatBiotech #bbv152 #COVID #clinicaltrial #Pandemic pic.twitter.com/nIWWDUKhvW

— BharatBiotech (@BharatBiotech) February 19, 2022

Covaxin (BBVI52), developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR), is a vaccine candidate currently under evaluation in the United States.

In the United States and Canada, Ocugen Inc is co-developing the Covaxin vaccine candidate for COVID-19.

"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 was quoted by PTI in its report.

"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," he further said.

Covaxin has been delivered to adults in over 200 million doses outside of the United States, and it is now approved for emergency use in 20 countries.

More than 60 more nations have applications for emergency usage authorization pending.

The World Health Organization (WHO) has included Covaxin in its list of emergency vaccinations. As many as 110 nations have agreed to reciprocal acceptance of COVID-19 immunisation certificates, including vaccination with Covaxin, with India.

In a subsequent tweet, Bharat Biotech stated that Covaxin is the only vaccine in India with published clinical evidence for children aged 2 to 18 while dismissing a few media reports that questioned the vaccine's efficacy.

#BharatBiotech #COVAXIN #Covaxin4Kids #COVID19 #FactCheck #VaccineMandate pic.twitter.com/G0ZL8wZvBb

— BharatBiotech (@BharatBiotech) February 19, 2022

"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 must pass more than 250 quality control tests before it can be distributed, according to the company. According to Bharat Biotech, the vaccine has been provided to over 300 million people worldwide.

"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 has 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.

(With PTI Inputs)