Intended for healthcare professionals


Covid-19: CDC and FDA approve Pfizer and Moderna vaccines for under 5s

BMJ 2022; 377 doi: (Published 20 June 2022) Cite this as: BMJ 2022;377:o1507
  1. Janice Hopkins Tanne
  1. New York

The US Centers for Disease Control and Prevention and the Food and Drug Administration have approved both the Pfizer-BioNTech and Moderna covid-19 vaccines for children aged 6 months to 5 years.1 This is the final group eligible for vaccination in the US.

CDC director Rochelle Walensky gave approval on 18 June, following previous approval by advisory committees and the FDA. She recommended vaccination for about 20 million children in this age group with whichever vaccine is available.

Walensky said, “We have taken another important step forward in our nation’s fight against covid-19. We know millions of parents and caregivers are eager to get their young children vaccinated, and with today’s decision they can.” At a Senate committee hearing on 16 June Walensky said that at present covid-19 was one of the leading killers of children.

She recommended that all children be vaccinated, including those who had already been infected with SARS-CoV-2. About 75% of young children are thought to have been infected. The vaccines are free.

The Pfizer-BioNTech vaccine is given in three injections: two doses given three weeks apart, followed by a third dose eight weeks later. The Moderna vaccine is given in two doses a month apart.

Anticipating approval, President Joe Biden made 10 million paediatric doses available, and 49 of the 50 states and the District of Columbia have pre-ordered them. Florida, headed by Republican governor Ron DeSantis, did not. DeSantis said the “risks outweigh the benefits,” but on 17 June, as approval seemed imminent, he changed course and allowed doctors and pharmacies in Florida to order the vaccines. The state’s health department had previously criticised vaccinations for adults.2

Although vaccines are widely available for older age groups, only 67% of Americans are fully vaccinated, and only 30% of those aged 5 to 11 years.3

Walensky said, “I encourage parents and caregivers with questions to talk to their doctor, nurse, or local pharmacist to learn about the benefits of vaccinations and the importance of protecting their children by getting them vaccinated.”

Parents who are reluctant to get their young children vaccinated are not necessarily ignorant or antiscience, said Jennifer Reich, a sociology professor at the University of Colorado, Denver, writing in the Washington Post. They weigh the risks and benefits, although they may underestimate the risk of infection and overestimate the risk of adverse reactions. “Before covid, as many as one third of American parents were taking a cafeteria approach to childhood vaccines, accepting some and rejecting others, based on their perceptions of safety, perceived seriousness of the disease, and estimated risk of infection,” she wrote.4

“Any successful vaccine campaign for children will have to address parents’ questions and concerns, and show that the vaccine, for which there is limited trial data, is effective in preventing serious illness and is safe for young children,” Reich added.

Marty Makary, a surgeon and public policy researcher at Johns Hopkins University who is also a medical contributor to Fox News, posted several items on Twitter criticising the FDA’s approach to approving mRNA vaccines. He said, “I’m very concerned they are using very little primary data in that age group [6-23 months]. Instead they are extrapolating, assuming data from older people apply to 6-month old babies.”5

Elsewhere, four Republican Congressmen, supported by 14 others, wrote to FDA’s head, Robert Califf, complaining that the CDC and FDA had a one-size-fits-all policy of getting the vaccine into people “regardless of age, risk factors, the underlying health of the individual, or previous infection” and that many questions about the vaccines remained unanswered. They said that the FDA should respond to 19 points, including releasing more data, providing more information about children in the clinical trials, and answering questions about cardiac risks and efficacy among the youngest children, among others.6 The four Congressman—Bill Posey of Florida, Louie Gohmert and Ted Cruz of Texas, and Ron Johnson of Wisconsin— previously voted to repeal President Barack Obama’s Affordable Care Act and to overturn the 2020 presidential election.


View Abstract