NEW DELHI: Bharat Biotech announced on Saturday that its Covaxin will be evaluated in the United States as a COVID-19 vaccine candidate.
Ocugen Inc, Bharat Biotech’s US and Canadian partner for Covaxin, announced in a statement 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), developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is a vaccine candidate product under investigation 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 advance our Covaxin clinical program, which we hope will bring us closer to offering an alternative COVID-19 vaccine,” said Ocugen CEO and co-founder Shankar Musunuri in a statement.
“We firmly believe that managing this pandemic requires more than one approach to vaccines,” he continued, “so we are encouraged to be able to continue developing our vaccine candidate.”
Covaxin has been administered to adults in over 200 million doses outside of the United States, and it is currently approved for emergency use in 20 countries.
More than 60 other countries have applications for emergency use authorization pending.
The World Health Organization (WHO) recently added Covaxin to its list of emergency vaccines. As many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates, including vaccination with Covaxin, with India.
In a separate tweet, Bharat Biotech stated that Covaxin is the only vaccine in India with published clinical data for children aged 2 to 18 while dismissing a few media reports that questioned the vaccine’s efficacy.
These trials were carried out in accordance with regulatory approvals from the CDSCO and DCGI, according to the company.
The vaccine was tested on 175 subjects between the ages of 12 and 18, as well as 350 children under the age of 12.
“It was one of the few vaccines studied in children with published results. Covaxin has over 15 publications elucidating all aspects of safety, immunogenicity, efficacy, and effectiveness in adults and children. This level of data transparency indicates a high level of trust in the product “According to the company.
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 administered to over 300 million people worldwide
“Since the start of the children’s vaccination program on January 3, 2022, 70% of the children in the 15-18 year age group have received the first dose, and more than 25% of the children in the 15-18 year age group have also received their second doses,” the report stated.
Since January 2022, over 7 crore doses have been administered to children, according to the report.