On Friday, June 17, the FDA granted emergency authorization of COVID-19 vaccines for infants and toddlers. Vaccinations for kids 5 and under are expected to roll out as early as June 21, 2022 — aka within the next week.
The FDA approved vaccines from Moderna and Pfizer/BioNTech for children as young as 6 months old, meaning that roughly 18 million kids under the age of 5 are now eligible to get vaccinated and hopefully close one of the largest remaining immunization gaps in the country. Previously, only the Pfizer vaccine was available to kids 5 and up, while the Moderna vaccine was available to children age 6 and older.
The FDA’s approval follows its independent advisory panel’s unanimous recommendation for the vaccines from both companies, saying that “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 authorized for use for each vaccine,” in its press release.
“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,” said FDA Commissioner Robert M. Califf, M.D.
“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,” Califf concluded.
Before the vaccines for kids 5 and under can officially roll out, the CDC has to meet and vote on guidelines for pharmacies and doctor’s offices. CDC Director Dir. Rochelle Walensky then has to sign off on said guidelines.
NPR reports that during a Senate hearing Thursday, Walensky noted that her staff was working over the Juneteenth federal holiday weekend "because we understand the urgency of this for American parents,” also noting that pediatric deaths from COVID-19 have been higher than what we typically see of the flu.
"So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders," she said.
President Biden celebrated the announcement, saying in an official statement, “Today’s decision will help build on this progress, giving parents much-needed relief and peace of mind and helping our nation continue to move forward safely. We look forward to hearing from the CDC on its recommendations.”
The Pfizer vaccine, which was approved for children from 6 months to 4 years old, is delivered in three doses that are one-tenth of the adult dose. The first two shots are given three weeks apart, and the final shot at least two months later.
Moderna’s vaccine, which was approved for children 6 months to 5 years old, is only two shots, each of which is a quarter of the adult dose. These two shots are given four weeks apart, and the FDA approved a third dose for children with immune conditions. This third booster shot is given a month after the second.
Schedule those shots for your tots, people!