FDA Says Both Moderna and Pfizer Covid-19 Vaccines Are Effective for the Youngest Children

A panel of experts is set to vote Wednesday on whether the agency should authorize the use of the vaccines for little kids

A nurse puts a band-aid on a child after he received a shot
Vaccinations could begin as soon as next week if the FDA authorizes either the Pfizer or Moderna shots for kids under 5.  FatCamera via Getty Images

Both the Moderna and Pfizer Covid-19 vaccines are safe and effective for kids under 6 and 5 years old, respectively, the U.S. Food and Drug Administration wrote in two separate briefing documents late last week and over the weekend

A panel of experts is set to vote Wednesday, June 15, on whether the administration should authorize the two companies’ shots for little kids. If they vote in favor of either, vaccinations could begin as soon as next week, write Matthew Perrone and Mike Stobbe for the Associated Press. The meeting will also discuss whether to limit the shots to only those at high risk for disease or to allow broad access to children.

“Given the uncertainty of the Covid-19 pandemic and likelihood of continued SARS-CoV-2 transmission during the ensuing months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on Covid-19-associated morbidity and mortality in this age group,” the FDA writes in the Pfizer briefing

About 18 million children under 5 are the only Americans currently not eligible for a Covid-19 vaccine. Currently, Pfizer’s vaccine is the only option for children 5 to 17. Moderna seeks authorization for its vaccine for kids ages 6 months to 17. Both Moderna and Pfizer’s vaccines for adults consist of two doses of mRNA that codes for SARS-CoV-2’s spike protein.

Both companies are proposing different dose numbers and strengths for little kids, with Moderna’s at two doses one-fourth the strength of an adult dose for those under 6 and Pfizer’s at three doses one-tenth the strength of an adult shot for under 5, writes Sharon LaFraniere for the New York Times. The single-dose Johnson & Johnson/Janssen DNA vaccine is the only other FDA-approved vaccine for those 18 or older, though its effectiveness in pediatric patients is still being studied.

Moderna reported its vaccine was 51 percent effective at preventing symptomatic illness in children between 6 months and 2 years old and 37 percent effective in kids between 2 and 5, per the Times. Pfizer reported 75.6 percent effectiveness for kids 6 to 23 months old, and 82.4 percent for childrren 2 to 4 years old, though only ten Covid-19 cases were reported, writes Laurie McGinley for the Washington Post. Twice that number of cases is required to establish overall vaccine efficacy, per the Times. The two companies also tested their shots last year, when the Delta and Omicron variants were predominant, where newer variants have since emerged, writes Lauran Neergaard for the Associated Press

“There will be two types of parents: ones that will really embrace the vaccines and others who are going to wait and see,” John P. Moore, a professor of microbiology and immunology at Weill Cornell Medicine, tells the Washington Post. “It can be serious for children, but that’s very rare…It’s very different for Granny and Granddad, who are in a much higher risk group. For them, it is a no-brainer.”

The risk of Covid infection for children in the U.S. has varied over the last two years. Since the beginning of the pandemic, 13.5 million children have tested positive for Covid. In early June, children aged less than 18 were about 14 percent of infections (while being about 22 percent of the total population). On the other hand, children have borne a huge brunt of the pandemic at other times—kids ages 0 to 4 were five times more likely to be hospitalized during the winter 2021 omicron wave than during previous waves. About 23 million kids ages five and up have completed vaccination using the Pfizer vaccine, currently the only vaccine available for anyone under the age of 18. The CDC reports that since the beginning of the pandemic, there have been about 1200 deaths caused by Covid in people younger than 18.

Only a few other countries, including China and Cuba, offer vaccines for kids under the age of 5, per the AP.