Bharat Biotechs US partner Ocugen files request with FDA for Covaxin trials
Hyderabad Oct 27 PTI Ocugen Bharat Biotechs US partner for COVID-19 vaccine Covaxin on Wednesday said it has submitted Investigational New Drug Application IND to the US Food and Drug Administration to conduct clinical trials The development comes a day after the World Health Organisation sought more details from Bharat Biotech to consider its COVID-19 vaccine Covaxin for Emergency Use Listing The US firm in a press release said the Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative healthy adult population in the USA The US drug regulator earlier in June recommended Ocugen Inc to go for Biologics Licence Application BLA route with additional data instead of Emergency Use Authorisation EUA The proposed trial can be to people who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier in the USA We are very excited to take this next step in the development of Covaxin which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public We are hopeful that the study conducted under the IND if allowed to proceed will help demonstrate that the data from India will be applicable to the US population Dr Shankar Musunuri Chairman of the Board Chief Executive Officer and Co-Founder of Ocugen said If the study is allowed to proceed Ocugens Phase 3 immuno-bridging study OCU-002 will seek to enroll several hundred healthy adults in the US Subjects will be randomized to receive either two doses of Covaxin or placebo 28 days apart The Phase 3 study conducted in India by Ocugens business partner Bharat Biotech involved 25798 participants receiving two doses of Covaxin or placebo 28 days apart Ocugen has already sought regulatory approval from Health Canada for Covaxin to be used in that country Covaxin is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades PTI GDK BN BN
Hyderabad Oct 27 PTI Ocugen Bharat Biotechs US partner for COVID-19 vaccine Covaxin on Wednesday said it has submitted Investigational New Drug Application IND to the US Food and Drug Administration to conduct clinical trials The development comes a day after the World Health Organisation sought more details from Bharat Biotech to consider its COVID-19 vaccine Covaxin for Emergency Use Listing The US firm in a press release said the Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative healthy adult population in the USA The US drug regulator earlier in June recommended Ocugen Inc to go for Biologics Licence Application BLA route with additional data instead of Emergency Use Authorisation EUA The proposed trial can be to people who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier in the USA We are very excited to take this next step in the development of Covaxin which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public We are hopeful that the study conducted under the IND if allowed to proceed will help demonstrate that the data from India will be applicable to the US population Dr Shankar Musunuri Chairman of the Board Chief Executive Officer and Co-Founder of Ocugen said If the study is allowed to proceed Ocugens Phase 3 immuno-bridging study OCU-002 will seek to enroll several hundred healthy adults in the US Subjects will be randomized to receive either two doses of Covaxin or placebo 28 days apart The Phase 3 study conducted in India by Ocugens business partner Bharat Biotech involved 25798 participants receiving two doses of Covaxin or placebo 28 days apart Ocugen has already sought regulatory approval from Health Canada for Covaxin to be used in that country Covaxin is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades PTI GDK BN BN
