New Delhi: In what comes as a major relief for parents, an expert panel on Tuesday granted emergency use approval (EUA) to Covaxin – Bharat Biotech’s COVID-19 vaccine for children between the ages of two and 18. “After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the Subject Expert Committee (SEC) stated in its recommendations.Also Read - WHO Experts Recommend Additional COVID Vaccine Dose for People with Weak Immune Systems
The final approval, however, will be given by the Drug Controller General of India (DCGI). Once approved, Covaxin will become the second vaccine to be cleared for use on children. Earlier this month, Bharat Biotech had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab.
Emergency use authorisation by DCGI-CDSCO, however, is subject to these four conditions:-
- Continue Study as per Whole Virion: The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol”, the drug regulator said.
- Provide updated PI, SmPC: The firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet
- Submit Safety Data: The firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per the requirement of New Drugs & Clinical Trials Rules, 2019;
- Risk Management Plan: The firm should submit a risk management plan.
In August DCGI had granted emergency approval to the Zycov-D, a COVID-19 vaccine developed by the Ahmedabad based Zydus Cadillac group for use in adolescents 12 years old and above.
Zycov-D is the world’s first DNA-based vaccine against the coronavirus, and this three-dose vaccine when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance. The vaccine has been developed in partnership with the DBT under Mission COVID Suraksha.
Until now vaccines Covishield, Covaxin and Sputnik V are being given to only those above 18 years of age and unlike ZyCoV-D, these are two-dose vaccines.
Meanwhile, Chief medical officers in the UK, have approved only one dose of a Covid vaccine, to healthy children aged 12 to 15, over fears of the risk of myocarditis — inflammation of the heart muscle.
On the other hand, Pfizer and its German partner BioNTech had also urged the Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for children ages 5 to 11.
Moderna had also requested FDA permission to use its vaccine in 12- to 17-year-olds and also is studying its shots in elementary school children. Both Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.