Categories: Uncategorized

USFDA denies Bharat Bhiotech’s partner emergency approval for Covaxin

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.

Medically Speaking Team

Recent Posts

ANTIBIOTIC MISUSE IN INDIA: HOW IT’S MAKING INFECTION TREATMENT MORE CHALLENGING

Antibiotic use has surged globally, leading to a rise in antibiotic resistance, especially concerning in…

6 hours ago

CHILD DIES FROM CHOKING ON CANDY: HOW TO SAFEGUARD AGAINST CHOKING HAZARDS IN YOUNG CHILDREN

Choking is a leading cause of injury and death in young children, particularly those under…

7 hours ago

Video: How Hard Water Leads to Hair Fall and Expert Tips to Combat It

Hard Water (Khara Pani) Leading To Hair Fall Hard water is rich in minerals and…

9 hours ago

“How High Blood Pressure During Pregnancy Is Rising: What Every Expectant Mother Should Know”

Discover how the rise in high blood pressure during pregnancy is impacting maternal and fetal…

9 hours ago

“Revitalize Your Weight Loss Journey: 6 Powerful Homemade Drinks to Naturally Melt Away Fat!”

"Discover the transformative power of six delicious homemade drinks that can help you naturally melt…

9 hours ago

“Revitalize Your Weight Loss Journey: 8 Powerful Fat-Flushing Drinks to Boost Your Results!”

"Transform your weight loss routine with these eight delicious fat-flushing drinks that not only hydrate…

9 hours ago