Bharat Biotech on Saturday received approval for emergency use authorization of the Covaxin Covid-19 vaccine for children in the 12-18 years age group by the Drug Controller General of India (DGCI), said authorities.
Covaxin is now the second vaccine cleared for use for children in India. In August, The Drugs Controller General of India (DCGI)
gave approval for emergency-use authorization of Zydus Cadila’s ZyCoV-D vaccine, the Union Ministry of Science and Technology said. The world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 will be administered in humans including children and adults 12 years and above, the ministry said.
Bharat Biotech recently submitted the phase 3 clinical trial application to the Drugs Controller General of India (DCGI) to get approval for the booster dose of its intranasal Covid vaccine named ‘BBV154’.
- Bharat Biotech received approval for emergency use authorization of Covaxin for kids aged 12-18.
- Covaxin is now the second vaccine cleared for use for children in India.
- In August, DCGI gave approval for emergency-use authorization of Zydus Cadila’s ZyCoV-D vaccine.
A committee had noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26. After detailed deliberation, the committee had recommended the grant of market authorisation of the vaccine for the two to 18 years age group for restricted use in emergency situations subject to certain conditions.
