new Delhi: Bharat Biotech on Saturday said its Covaxin will be evaluated as a COVID-19 vaccine candidate in the US.
In a statement, India Biotech’s partner in the US and Canada for Covaxin, OcuGen Inc., said the US health regulator – the US Food and Drug Administration (FDA) has lifted its clinical hold to evaluate a COVID-19 vaccine candidate. Is. BBV152, known outside the US as Covaxin.
Covaxin (BBVI52), 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.
“We are delighted to be able to advance our clinical program for Covaxin, which we hope offers us an alternative COVID-19 vaccine,” Ocugen CEO and co-founder Shankar Musunuri said in a statement. will bring it closer.”
He continued: “We strongly believe that more than one approach to vaccines is needed to manage this pandemic, so we are excited to be able to develop our vaccine candidate.” With more than 200 million doses administered to adults outside the US, Covaxin is currently authorized for emergency use in 20 countries.
Applications for emergency use authorization are pending in more than 60 other countries.
The World Health Organization (WHO) has recently added Covaxin to its list of authorized vaccines for emergency use. More than 110 countries have agreed with India for mutual recognition of COVID-19 vaccination certificates which include vaccination using Covaxin.
In a separate statement on Twitter, Bharat Biotech noted that Covaccin is the only vaccine in India that has published clinical data for children aged 2-18 years, while debunking some media reports that have been in the lab. raises questions about its effectiveness.
These tests were conducted on the basis of regulatory approvals by CDSCO and DCGI, it said.
It said the vaccine was evaluated in 175 subjects aged 12-18 years and in 350 subjects in children under 12 years of age.
“It was one of the few vaccines to be evaluated in children with published data. Overall, Covaxin has more than 15 publications that elucidate all aspects of safety, immunogenicity, efficacy, and effectiveness in adults and children. Data transparency. This level of confidence reflects a high level of confidence in the product,” the company said.
It states that each batch of Covaxin requires more than 250 quality control tests before being released for supply. Bharat Biotech said the vaccine has been administered to more than 300 million subjects globally.
“Since the start of the children’s immunization program on January 3, 2022, 70 percent of children aged 15-18 have received the first dose, and over 25 percent of children in the 15-18 age group have also received their second dose. dose received,” it said.
More than 7 crore doses have been given to children since January 2022.
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