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

Attack On Dharmasala MLA In Odisha: BJD, BJP Trade Charges Over Police Action

Jajpur: Ruling BJP and Opposition BJD were engaged in trading charges against each other on…

November 24, 2024

After Jaiswal-Kohli-Bumrah Heroics, Can India Beat Australia By Record Margin In 1st Test?

Perth: It was the perfect day of Test cricket for Team India. The visiting team…

November 24, 2024

Youth Beats Old Mother To Death In Odisha’s Angul

Angul: A youth allegedly beat his old mother to death following an argument over a…

November 24, 2024

Virat Kohli Thanks Anushka After Breaking Century Drought [Watch]; Check His Feats

Perth: He hadn’t scored a Test century for 16 months. His previous 15 Test knocks…

November 24, 2024

BJD’s Minority Cell Stages Protest Against Waqf Bill In Bhubaneswar

Bhubaneswar: The members of BJD's minority cell staged a demonstration in front of Raj Bhavan…

November 24, 2024

System Over Bay Of Bengal To Trigger Rain In Odisha, Push Up Night Temp By 2-4°C

Bhubaneswar: Dense fog reduced visibility in Odisha's Rourkela while moderate fog engulfed Koraput, Bhawanipatna and…

November 24, 2024

IPL Auction: Rishabh Pant Sold At Record Rs 27 Cr After Shreyas Iyer Fetches Rs 26.75 Cr

Mumbai: Shreyas Iyer may be out of the Indian team currently, but the dashing right-handed…

November 24, 2024

What Did PM Narendra Modi Take From Odisha As Gift During 3-Nation Visit?

Bhubaneswar: A rare and exquisitely crafted Filigree boat made of pure silver from Odisha was…

November 24, 2024