Covaxin For Children Will Take Some More Time For Final Approval: Sources

New Delhi: The data for Bharat Biotech’s Covaxin for Children, COVID-19 vaccine for children, is under evaluation and the process will take some more time for final approval from the Drugs Controller General of India (DCGI), sources said. “It’s a sensitive matter. Data evaluation is underway. More data has been submitted,” sources informed ANI.

Also Read: Decision On Vaccination Of Children To Be Based On Scientific Rationale: Dr V K Paul

Recently, the Subject Expert Committee (SEC) had given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech’s Covaxin COVID-19 vaccine for the beneficiaries aged between 2-18 years.

After evaluation of the data, the final approval will be given by the Drug Controller General of India (DCGI). Earlier, Bharat Biotech, in an official statement, had said they are waiting for further approvals from the drug regulators.

This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thanks 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, their statement read.

Bharat Biotech had submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to Central Drugs Standard Control Organisation (CDSCO). The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and has provided their positive recommendations, the vaccine maker said. The Subject expert committee on COVID-19 has already examined the data.

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 an emergency situation subject to the setting conditions.

Earlier on November 3, the World Health Organisation (WHO) had also given Emergency Use Listing (EUL) to Covaxin.

Also Read: Mix-and-match Vaccines Highly Effective Against COVID-19: Lancet Study

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

NDTV – Dettol have been working towards a clean and healthy India since 2014 via Banega Swachh India initiative, which is helmed by Campaign Ambassador Amitabh Bachchan. The campaign aims to highlight the inter-dependency of humans and the environment, and of humans on one another with the focus on One Health, One Planet, One Future – Leaving No One Behind. It stresses on the need to take care of, and consider, everyone’s health in India – especially vulnerable communities – the LGBTQ population, indigenous people, India’s different tribes, ethnic and linguistic minorities, people with disabilities, migrants, geographically remote populations, gender and sexual minorities. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign will continue to raise awareness on the same along with focussing on the importance of nutrition and healthcare for women and children, fight malnutrition, mental wellbeing, self care, science and health, adolescent health & gender awareness. Along with the health of people, the campaign has realised the need to also take care of the health of the eco-system. Our environment is fragile due to human activity,  that is not only over-exploiting available resources, but also generating immense pollution as a result of using and extracting those resources. The imbalance has also led to immense biodiversity loss that has caused one of the biggest threats to human survival – climate change. It has now been described as a “code red for humanity.” The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene. Banega Swasth India will also be taking forward the dream of Swasth Bharat, the campaign feels that only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and the country can become a Swasth or healthy India.