Written By: Longjam Dineshwori | Updated : June 18, 2022 9:29 AM IST
The US Food and Drug Administration (FDA) on Friday approved Moderna and Pfizer-BioNTech COVID-19 vaccines for use in children 6 months to 5 years of age.
In a statement, the agency highlighted that the known and potential benefits of these two COVID-19 vaccines outweigh the known and potential risks in the paediatric populations authorised for use for each vaccine.
FDA Commissioner Robert M Califf stated that this action will help protect children down to 6 months of age from severe outcomes of COVID-19, such as hospitalisation and death. He added that many parents, caregivers and clinicians have been waiting for a vaccine for younger children.
The Moderna COVID-19 vaccine had already been authorised for use in adults 18 years of age and older. The FDA revised the emergency use authorisation (EUA) to include children 6 months to 17 years of age.
Similarly, the FDA amended the EUA of the Pfizer-BioNTech vaccine, which had been authorised for use in individuals 5 years of age and older, to include younger children down to 6 months of age.
Children 6 months to 17 years of age is given a two-dose primary series of the Moderna vaccine at 25 micrograms (mcg) per dose, one month apart. The vaccine is also authorised to provide a third primary series dose for immunocompromised children in this age group. The booster dose is administered at least one month following the second dose.
On the other hand, the Pfizer-BioNTech vaccine is administered as a primary series of three doses to children 6 months to 4 years of age. While the initial two doses are administered three weeks apart, a third dose is administered at least eight weeks after the second dose.
The FDA noted that clinical trials have shown that the immune response to the vaccines, for younger children, was comparable to the immune response of the adults.
However, both the FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna and Pfizer-BioNTech vaccines, particularly following the second dose.
According to the FDA, the observed risk is highest in males 18 to 24 years of age for the Moderna vaccine and in males 12 to 17 years of age for the Pfizer-BioNTech vaccine.
On the same day (Friday), Hyderabad-based vaccine manufacturer Bharat Biotech also announced that its whole-virion inactivated COVID-19 vaccine Covaxin has proven to be safe, well-tolerated and highly immunogenic in paediatric population in phase II/III study.
The study has been published in Lancet Infectious diseases, the company said in a statement.
The clinical trial, which included healthy children and adolescents in 2-18 years of age group, was conducted between June 2021 and September 2021. The data showed safety, less reactogenic, and robust immunogenicity of Covaxin in the paediatric population, Bharat Biotech said.
The vaccine manufacturer submitted the data to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, after which it was authorised for emergency use in children aged 6-18 years.
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said that Covaxin is a highly safe vaccine for children, and data from more than 50 million doses of administered to children in India proves it.
As per the company, no serious adverse event was observed in the study. Majority of adverse events reported were mild in nature and resolved within one day. The most commonly reported adverse event was pain at the injection site, it added.
