This Friday, the U.S. Food and Drug Administration. The FDA has authorized the emergency use of the vaccine for children 6 months to 4 years of age, from Moderna Pharmaceuticals and the Pfizer-BioNTech vaccine for the prevention of COVID-19 disease.
For the Modern COVID-19 vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in persons 6 months to 17 years of age. The vaccine had been licensed for use in adults 18 years of age and older.
In the case of the Pfizer-BioNTech COVID-19 vaccine, the FDA amended the EUA to license the vaccine for use in persons 6 months to 4 years of age. In addition, the vaccine had already been licensed for use in persons 5 years of age and older.
The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations licensed for use of each vaccine.
Prior to making the decision to license these vaccines for the respective pediatric populations, the FDA's Vaccines and Related Biological Products Advisory Committee was consulted and voted in favor of the licenses.
"Many parents, caregivers and physicians have been waiting for a vaccine for younger children and this action will help protect those under 6 months of age. As we have seen with the older age groups, we expect vaccines for younger children will provide protection against the more serious outcomes of COVID-19, such as hospitalization and death," said Dr. Robert M. Califf, FDA commissioner.
"Child care can be confident in the safety and efficacy of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data," he added.
Modern COVID-19 vaccine is administered as a two-dose primary series, one month apart, to persons 6 months through 17 years of age. The vaccine is also licensed to provide a third dose of the primary series at least one month after the second dose for persons in this age group who have been determined to have certain types of immunosuppression.
In turn, the Pfizer-BioNTech COVID-19 vaccine is administered as a three-dose primary series in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in persons 6 months to 4 years of age.
"As with all vaccines for any population, in licensing COVID-19 vaccines intended for pediatric age groups, FDA ensures that our evaluation and analysis of the data is rigorous and thorough," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research.
Efficacy for children from six months to 4 years of age.
The effectiveness and safety data evaluated and analyzed by the FDA for Modern COVID-19 vaccine to support EUA for these pediatric populations were generated in two ongoing, randomized, blinded, placebo-controlled clinical trials in the United States and Canada involving infants, children and adolescents.
Meanwhile, efficacy and safety data evaluated and analyzed by the FDA for the Pfizer-BioNTech COVID-19 vaccine were generated in an ongoing, randomized, blinded, placebo-controlled clinical trial in the United States and internationally, which enrolled infants and children, where the immune response to the vaccine for both age groups of children was found to be comparable to that of older participants.
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