In a recent development, the US Food and Drug Administration there has “recommended” Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
Occugen on Thursday announced that as recommended by the FDA, it will pursue submission of a biologics licence application (BLA) for Covaxin.
Occugen further said that the development may delay the Covaxin launch in the US.
Reacting to the FDA”s “recommendation”, Bharat Biotech said with good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States, the US regulator had earlier communicated that no new EUAs will be approved for COVID-19 vaccines.
“All applications have to follow the biological license application process, which is the standard process for vaccines. Data from an additional clinical trial will be required to support the marketing application submission for Covaxin,” the vaccine maker said.
Dysautonomia: The Silent Illness Impacting Millions of People Worldwide Dysautonomia is an umbrella term used…
https://youtu.be/mdl3AFFFcuk?si=i2cYzTX7WJ-z6wRp Does Chyawanprash Help in Cough & Cold? Exploring Its Benefits and Efficacy Chyawanprash, a…
Walk In Winter: In winter, the time from 7:00 AM to 9:00 AM is considered…
Does Maida Stick To Your Gut Lining: In this article, we debunk the common myth…
https://youtu.be/4NTKSfNf1TM?si=Y4xkEOKDUvqpIEZt The Disadvantages of Heating Packaged Milk Milk is a staple in many households and…
A recent study has revealed a growing mental health crisis among teenagers globally, with nearly…