Close
Achema middle east
swop processing & packaging

Bharat Biotech’s Covaxin granted emergency use approval for kids aged 2-18 years

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access the Media Pack Now

– Book a Conference Call

Leave Message for Us to Get Back

Related stories

Lonza Widens Cell and Gene Therapy Suite with New Products

Lonza widens cell and gene therapy suite by way...

No New Drug Submissions by the FDA With Shutdown in Place

The Food and Drug Administration (FDA), which is already...

How to Tell if Your Loved One is Developing an Addiction

Watching a loved one change in ways you do...

The Future of Balding Treatments: What’s New in 2025

Are you balding or thinning out on top? It...

The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group.

Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month.

“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation,” the subject expert panel said in a statement.

The made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.

In a statement, Bharat Biotech said the clinical trial data it had submitted was thoroughly reviewed by the Central Drugs Standard Control Organisation (CDSCO) and SEC, who provided their positive recommendations.

“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” the vaccine developer said.

Latest stories

Related stories

Lonza Widens Cell and Gene Therapy Suite with New Products

Lonza widens cell and gene therapy suite by way...

No New Drug Submissions by the FDA With Shutdown in Place

The Food and Drug Administration (FDA), which is already...

How to Tell if Your Loved One is Developing an Addiction

Watching a loved one change in ways you do...

The Future of Balding Treatments: What’s New in 2025

Are you balding or thinning out on top? It...

Subscribe

- Never miss a story with notifications

- Gain full access to our premium content

- Browse free from any location or device.

Media Packs

Expand Your Reach With Our Customized Solutions Empowering Your Campaigns To Maximize Your Reach & Drive Real Results!

– Access theMedia Pack Now

– Book a Conference Call

Leave Message for Us to Get Back

Translate »