FDA announces COVID-19 vaccines for toddlers and infants

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Christian Emmer | Children’s Action Alliance

Farah Javed, Copy Chief

Following unanimous support from advisors to the Food and Drug Administration, the FDA announced on June 17 that children between six months of age and under five years old can now receive the Moderna and Pfizer COVID-19 vaccines.

The final authorization steps were taken on June 18 when this decision was recommended by the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and also endorsed by CDC director Dr. Rochelle Walensky.

According to the CDC’s “Provisional COVID-19 Deaths: Focus on Ages 0-18 Years” database, updated as of June 2, 2022, approximately 1,250 children between the ages of 0-18 died from COVID-19.

“If we have a way to prevent deaths, we should be preventing them,” Yvonne Maldonado, pediatrician and infectious-disease specialist at Stanford University, said.

The FDA’s Vaccines and Related Biological Products Advisory Committee was asked whether the benefits of two doses of the Moderna vaccine outweigh potential risks for use in infants and children in this younger age group. All 21 members answered yes.

“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 Califf, M.D. said in an FDA news report. “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.”

Pfizer had initially sought approval on Feb. 2022. Still, the FDA delayed the decision because it felt there wasn’t enough data on the medical impact its dosage could have on younger children.

While Moderna and Pfizer both received approval from the FDA, their dosage differs.

Children younger than 5-years-old who receive a Pfizer shot will get one-tenth of the adult dose. They will also receive two shots at first, three weeks apart, and then a third dose at least two months after.

Parents who opt for Moderna instead will bring their child, who can be younger than 6, for one shot that is a quarter of the adult dosage, and then for a second shot four weeks later. Immunocompromised children could also receive a third dose.

For some parents, the FDA’s announcement is long-awaited.

“I feel incredibly relieved,” Jessica Herring, who has waited to vaccinate her 2-year-old son, told NPR,. “Young children can finally have some protection beyond isolation and the actions of other people.”

Worried about their children’s physical and mental health, as children’s social interactions were limited, some parents like Herring feel they can “breathe a huge sigh of relief.”

McKenzie Pack expressed a similar sentiment about her son.

“He’s never really played with another kid inside before,” she said. “This will be a really big change for our family.

Others, however, are not as eager to get their infants and toddlers vaccinated.

An April survey by the Kaiser Family Foundation found that about 18% of parents want to vaccinate their child immediately, while 38% “plan to wait a while to see how the vaccine is working for others.”

In contrast, 27% of parents with kids under 5 will not get their kids vaccinated against COVID-19 at all. While reasons for this refusal vary from parent to parent, one parent under the pseudonym, Erin, told The Washington Post why she would not get her children vaccinated if they were eligible.

“I don’t think the risk is worth it unless the medical facility or whoever does all the testing was able to prove a hundred percent that there’s absolutely no way that there’s any kind of vaccine damage that can happen with this,” Erin said. “Which, I don’t really see that happening.”

Whether parents are rushing to get their children vaccinated or not, the doses are now available approximately a year and a half after COVID-19 vaccines first became available to adults.

Moderna and Pfizer doses for 6-months-olds through 5-years-olds started shipping out on June 19 and will be available by June 25, with some appointments even becoming available at Walgreens in South Carolina and New York City.

It should be noted that due to federal regulations, children under three will not be able to receive their vaccine at retail pharmacies and will instead have to visit their health care provider.