FDA Review of Pfizer Covid-19 Vaccine in Children Under 5 Expected Soon

A decision by the Food and Drug Administration, which has been evaluating results from research testing two doses of the shot in the children, is likely to come this month.

The FDA typically releases its assessment of an application ahead of a meeting of vaccine experts who advise the agency on regulatory requests. Their meeting is scheduled to take place Tuesday.

Some health experts have urged the FDA to hold off on authorization because the testing didn’t find that the vaccine produced a strong immune response in 2- to 4-year-olds, but only in children under 2.

The critics say the agency should wait for results of testing a third, or booster, dose to see if that generates a sufficient immune response.

Pfizer and BioNTech were going to wait for results from testing a booster dose before seeking FDA authorization in children under age 5.

Yet the FDA urged Pfizer and BioNTech to seek clearance, rather than wait for the booster data.

Rollout of the first two doses for young children would accelerate their access to a booster, if that third dose were found to work safely and authorized, The Wall Street Journal reported.

The FDA advisers scheduled to review the evidence of the vaccine’s safety and efficacy in young children—the Vaccines and Related Biological Products Advisory Committee—will vote to recommend whether the FDA should authorize the use.

Should the advisers give the go-ahead, shots could become available later this month at schools, pediatrician offices and other locations. Each dose for the younger children is one-tenth the dose given to older children and adults.

The Centers for Disease Control and Prevention has told local health officials they should be ready to receive their first shipments by Feb. 21.

In testing the shot for children under age 5, the companies said they didn’t observe any serious safety concerns.

Yet the efficacy results were mixed. In children between the ages of 2 and 5 years, the vaccines weren’t found to provide the kind of immune response researchers say is needed to protect against symptomatic Covid-19.

Some outside researchers have said children have less-mature antibody responses than adults, so they may need an extra dose to get the desired immune response. The companies have declined to speculate.

The companies have said they intend for children to receive three doses and would submit data supporting adding a booster that the children could receive at least eight weeks after their second dose.

Vaccine experts have said the FDA will face a thorny decision—and risk undermining its reputation for making decisions based on scientific evidence—if testing doesn’t show the booster works.

Approximately 19 million children in the U.S. are under 5 years. Some parents are eager to vaccinate their children—a group that was hospitalized in larger numbers during the recent Omicron surge than previously in the pandemic.

Many of the hospitalized children had underlying health conditions or were admitted for non-Covid-19 reasons but then got infected, according to research and the government.

Pediatricians and health authorities face a likely uphill climb in vaccinating the youngsters. Some 31% of parents of children under 5 years surveyed said they would get their child vaccinated immediately; 12% said they would vaccinate their children only if required to do so, 29% said they would wait, and 26% said they wouldn’t seek the vaccine at all, according to a recent survey by the Kaiser Family Foundation.

Write to Jared S. Hopkins at [email protected]