India

Bharat Biotech’s US Partner Seeks Approval For Paediatric Use Of Covaxin

By
OB Bureau

New Delhi: Ocugen Inc., Bharat Biotech’s partner for USA and Canada, has sought approval from the US Food and Drug Administration (FDA) for emergency use authorisation of Covaxin for paediatric use.

The submission is based on results of a Phase 2/3 paediatric clinical trial conducted by Bharat Biotech in India with 526 children 2-18 years of age, which bridged immunogenicity data to a large, Phase 3 safety and efficacy clinical trial in nearly 25,800 adults in India, Ocugen said in a regulatory filing, reported PTI.

“Filing for emergency use authorisation in the US for paediatric use is a significant step toward our hope to make our vaccine candidate available here and help combat the COVID-19 pandemic,” Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen said.

On November 3, the World Health Organisation gave emergency use licence to Covaxin. Travellers fully vaccinated with Covaxin can now enter the US from November 8, joining travellers fully vaccinated with other shots like Pfizer-BioNTech, Johnson & Johnson, Moderna, Oxford-AstraZeneca, Covishield, Sinopharm and Sinovac.

OB Bureau

Recent Posts

IPL Auction: KKR Break Bank For Venkatesh On Lucrative Day For Indian Players; Check Top Buys

Mumbai: The first day of the IPL mega player auction at Jeddah threw up several…

November 24, 2024

Odisha Govt Hands Over Case Of Attack On Dharmasala MLA To Crime Branch

Bhubaneswar: The Odisha government has handed over the investigation into the attack on Dhramasala MLA…

November 24, 2024

Commissionerate Police Issues Traffic Advisory During Winter Session Of Odisha Assembly; Details Here

Bhubaneswar: The Commissionerate of Police on Sunday issued an advisory for movement of vehicular traffic…

November 24, 2024

Elon Musk Proposal: Fire US Federal Employees Who Want To Work From Home

New York: Now that President-elect Donald Trump has tasked Elon Musk with the responsibility of co-heading…

November 24, 2024

Odisha Govt Warns Of Stern Action For Renting Out Its Quarters

Bhubaneswar: The Odisha government has warned its employees of stern action for sub-letting their allotted…

November 24, 2024

AR Rahman Best Man In The World, Certifies Saira Banu; Then Why Their Separation?

Mumbai: There has been a lot of talk over AR Rahman and his wife Saira…

November 24, 2024

Process On To Form NODC In 2-3 Months, Says Odisha CM Mohan Majhi

Sundargarh: The North Odisha Development Council (NODC) would be formed in 2-3 months, said Chief…

November 24, 2024

Odisha DGP Reviews Security Arrangements For President’s Visit To Puri

Puri: Director General of Police (DGP) YB Khurania on Sunday reviewed the security arrangements for…

November 24, 2024