FDA Grants EUAs to Moderna, Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

The FDA has granted an emergency use authorization (EUA) for the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to include use in children under 5 years of age down to 6 months of age.

For the Moderna COVID-19 vaccine, mRNA-1273 (Spikevax), the FDA amended the existing EUA to include use of the vaccine in individuals 6 months through 17 years of age. Earlier this year, Moderna received full FDA approval for the vaccine in individuals 18 years of age and older.

For the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, the FDA amended the EUA to include administration in children 6 months through 4 years of age. The vaccine had been previously authorized for use in individuals 5 years of age and older.

Since the COVID-19 pandemic began, more than 10.6 million children have tested positive for the virus in the United States, with more than 1.6 million younger than 4 years of age.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert M. Califf, MD, said in a press release. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”

Earlier this week, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to include administration of the Moderna mRNA-1273 vaccine for children and adolescents 6 through 17 years of age. VRBPAC split the vote for younger children and adolescents because of the different dosages in the vaccines.

For children aged 6-11 years, VRBPAC used 50 mcg for each dose, and for individuals 12-17 years of age, VRBPAC used 100 mcg for each dose. For both age groups, the vote was 22-0 in favor of amending the EUA.

In granting the EUA today for both vaccines, the FDA determined that the known and potential benefits for both vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.

mRNA-1273 is administered as a primary series of 2 doses, 1 month apart, and is also authorized for a third primary series dose at least 1 month following the second dose for immunocompromised individuals in this age group.

Data from the phase 2/3 TeenCOVE trial of mRNA-1273 in adolescents met the primary immunogenicity endpoint. TeenCOVE, which included more than 3700 adolescents in the United States, found that for fully vaccinated participants, there were no cases of COVID-19 versus 4 cases in the placebo group.

Vaccine efficacy in approximately 2500 adolescents administered mRNA-1273 was 100% when using the same case definition used in the COVE study in adults. Further, vaccine efficacy was 93% in seronegative participants starting 14 days after the first dose using the secondary CDC case definition of COVID-19.

In clinical trials, the most common adverse effects (AEs) for mRNA-1273 for both the 6 through 11 years of age group and the 12 through 17 years of age group included pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever.

The Pfizer-BioNTech COVID-19 vaccine is administered as a primary series of 3 doses, with the initial 2 doses administered 3 weeks apart, followed by a third dose at least 8 weeks after the second dose in children 6 months through 4 years of age.

Data released in May found that a third 3-µg dose of BNT162b2 elicited a strong immune response in children aged 6 months to under 5 years of age. Vaccine efficacy in this age group was 80.3%, with a descriptive analysis based on 10 symptomatic COVID-19 cases identified from 7 days after the third dose and accrued as of April 29, 2022.

The most common AEs in clinical trial participants 6 through 23 months of age administered BNT162b2 were irritability, decreased appetite, fever and pain, tenderness, redness and swelling at the injection site. These AEs were also reported in the 2 through 4 years age group, as well as fever, headache, and chills.

In terms of myocarditis risks, VRBPAC noted that some evidence indicates mRNA-1273 may carry a greater risk of myocarditis than BNT162b2, however the findings were not consistent in all US monitoring systems, according to the CDC. The agency verified 635 cases of myocarditis in those 5-17 years of age after 54.8 million Pfizer-BioNTech doses administered in this age group in the United States. The data showed the greatest risk for the condition is in the 16-17 years of age and 12-15 years of age groups, according to the presentation, with the highest number of cases occurring after the second dose and more so in males than females.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”

Reference

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age. FDA. News release. June 16, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children