Bharat Biotech’s US-based company Ocugen has filled a EUA application for administering the COVID-19 vaccine, COVAXIN to children aged between 2-18.
Bharat Biotech’s US-based company Ocugen has filled emergency use authorisation (EUA) application for administering its COVID-19 vaccine, Covaxin to children aged 2-18 in the United States.The vaccine is currently being administered in 17 countries across the world.
Bharat Biotech’s clinical lead for COVID-19 vaccine, Dr Raches Ella took to Twitter and wrote, “We are pleased to announce our EUA filling to the US-FDA through our partners- Ocugen.”
Earlier on Wednesday, the coronavirus vaccine, Covaxin which has been developed by Bharat Biotech received emergency use approval from the World Health Organisation and was informed that it is already in use in 17 countries.
Ocugen’s submission based on Phase 2/3 pediatric clinical trial in India
The submission by Ocugen was made on a basis of a Phase 2/3 pediatric clinical trial conducted earlier by Bharat Biotech in India with around 526 children between the age of 2-18. It was conducted to evaluate the safety, reactogenicity, and immunogenicity, of Covaxin. Later, the results from this took immunogenicity data to Phase 3 trial among adults.
An investigational vaccine candidate product in the US, Covaxin (BBV152) was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). It is a highly purified and inactivated vaccine that is manufactured using a vero-cell manufacturing platform.