Health · June 16, 2022

Moderna, Pfizer vaccines for children under 5 years old near FDA approval

A kindergarten student gives her teacher the thumbs up before starting day one of kindergarten Tuesday, August 17, 2021 at Laguna Niguel Elementary School in Laguna Niguel, CA.

Paul Bersebach | MediaNews Group | Getty Images

Moderna and Pfizer’s infant-to-preschool Covid-19 vaccines are one step closer to approval by the Food and Drug Administration.

The FDA’s committee of independent vaccine experts voted unanimously to recommend the vaccines for use in the youngest children after weighing how safe and effective they are during a day-long public session.

The FDA will likely accept the committee’s guidance and quickly approve the recordings. The Centers for Disease Control and Prevention must then approve the vaccines before pharmacies and doctor’s offices can start giving them to the children.

Parents will likely be able to have their children vaccinated as early as Tuesday, although Dr. Ashish Jha, who is overseeing the White House’s response to the pandemic, could initially be limited as the vaccination program ramps up.

Covid is generally less severe in children than in adults. However, hospitalizations of children under the age of 5 increased during the Omicron wave, reaching the highest level of the pandemic. According to the CDC, the hospitalization rate for these children during omicron was as bad or worse than any recent flu season.

Covid has killed 202 six-month-olds to 5-year-olds since January 2020. Children under the age of 5 are the only age group in the United States that are not eligible for vaccination. Many parents have been waiting for the FDA to approve the recordings for months.

“We have to be careful not to go deaf from the overwhelming number of elderly deaths given the number of pediatric deaths. Every life matters,” said Dr. Peter Marks, chief of the FDA’s Vaccine Division, told the committee.

“For those who have lost children to Covid-19, our hearts go out to them because every lost child essentially breaks a family apart,” Marks said.

Three-dose vaccine from Pfizer

The Pfizer and Moderna vaccines for the youngest children differ in many ways, including the number of shots used, the dosage level, and the age of approval.

Pfizer’s vaccine is given in three doses to children aged six months to four years. The shots are dosed at 3 micrograms, a tenth of what adults receive.

Pfizer’s three-dose vaccine was approximately 75% effective at preventing Omicron-related disease in children 6 months to 2 years of age and 82% effective against Omicron in 2- to 4-year-olds.

dr Doran Fink, a senior official in the FDA’s Vaccine Division, said the effectiveness of Pfizer’s vaccine after the third dose is an inaccurate estimate that could change as more data becomes available.

The third shot is crucial for Pfizer’s vaccine because two doses offered little protection. The FDA originally tried to expedite the first two doses in February, but Pfizer delayed the filing because the data wasn’t good enough. Two doses were about 14% effective in children under 2 years of age and 33% in children 2 to 4 years of age.

dr Paul Offit, a member of the FDA committee, said Pfizer’s 3-microgram doses may be too small. Offit said it’s important parents know their children aren’t protected after two doses and need to get the third Pfizer shot.

“I’m concerned that parents don’t necessarily realize that after two doses, they might be unprotected at all and engage in the type of activity that would put their child at risk,” said Offit, a pediatrician at Children’s Hospital of Philadelphia.

Modern two-dose vaccine

Moderna’s vaccine is given in two doses to children aged six months to five years. The shots are dosed at 25 micrograms, a quarter of what adults get.

Moderna’s two-dose vaccine was about 51% effective in preventing disease caused by Omicron in children ages six months to two years and about 37% in children ages two to five years. Moderna believes two doses will protect against serious illness from Omicron at similar levels seen in adults, said Jacqueline Miller, an executive at the company.

Moderna plans to release data later this summer on a third dose targeting the Omicron variant in this age group and asking the FDA to review that data as soon as possible, Miller said.

“However, because children under the age of 4 were at greatest risk of hospitalization due to Covid-19 during the Omicron surge, starting this vaccine series now is critical to begin protecting children this summer,” Miller told the committee .

Board member Dr. Jay Portnoy said he was disappointed Moderna’s vaccine hadn’t done a better job of preventing Covid infections. However, Portnoy said the shots would prevent children from becoming seriously ill.

“The evidence for preventing major illnesses, hospitalizations, and emergency visits is pretty strong,” said Portnoy, a professor of pediatrics at the University of Missouri-Kansas City. “This vaccine is very effective. It is also very safe to use,” he said.


The most common side effects of both vaccines, according to FDA presentations, are pain at the injection site, irritability and crying, loss of appetite and drowsiness. Very few children who received either vaccine developed a fever greater than 102 degrees Fahrenheit or 39 degrees Celsius. The children in the Pfizer and Moderna studies had no cases of myocarditis, a type of heart inflammation.

Committee member Dr. However, Cody Meissner said the safety profile of the vaccines in children under the age of 5 is not as well established as in adolescents and adults. Meissner, a professor of pediatrics at Tufts University, said the shots should be an option for parents, not a requirement. He said the FDA and CDC should continue to closely monitor the safety of the vaccines.

Marks, head of the FDA’s vaccines division, said the agency’s experts are working day and night to understand the safety profile of vaccines and will continue to do so. He said the FDA will alert the public to rare side effects, as it did with myocarditis in adolescent boys.

“The safety and efficacy of these vaccines is very important to us at the FDA, and we will continue to monitor these vaccines throughout their use,” Marks said.

Marks also cautioned the public against drawing conclusions about the safety of the vaccines from the FDA and CDC database, known as VAERS. Anyone can submit a report to this publicly available database, but experts have to comb through the raw data to determine when there really is a link between an adverse event and the vaccines, he said.

“For rare adverse events, we will make sure the public is made aware of them,” Marks said.

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