Why Parents Will Have to Wait for Kids Under 5 to Get COVID-19 Vaccine

The FDA said it became clear they needed to wait for data on how well a third shot works for the youngest age group, according to a recent press release.

Pfizer expects to have the data by early April.

According to Pfizerthe drug trial for children from 6 months to 4 years old hasn’t ended, and the drugmaker is sharing data on the first two doses in this age group with the FDA on an ongoing basis.

“Cases continue to accumulate according to the study protocol, and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge,” Pfizer explained in a statement.

The company said that the independent Data Monitoring Committee (DMC) for the study supports continuing the trial and finds data collected to date show the vaccine is “well tolerated and support a potential three-dose regimen.”

“We take our responsibility for reviewing these vaccines very seriously,” Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said during a recent media call.

“In looking over these data, I think parents can feel reassured that we have set a standard by which we feel that if something does not meet that standard, we can’t proceed forward,” he said.

Peter Pittspresident of the Center for Medicine in the Public Interest and former FDA Associate Commissioner, said that once the data is available on vaccine effectiveness for kids under 5, the committee will be able to move quickly.

He said that if the FDA votes to authorize the vaccine for children under 5, the CDC would hold an Advisory Committee on Immunization Practices (ACIP) meeting on the same issues and then vote. The vaccine could then be made available to young children within days of these decisions.

“If Pfizer can share more and more positive data before the end of the month, I believe it means the vaccine could be ready for use before St. Patrick’s Day,” he said.

Pitts pointed out that even before this vaccine is authorized for young children, the vaccination rate for children over 5 remains low.

Pitts called the vaccination rate for children under 12 “dismal” and said it must improve if we’re to move from a pandemic to “a more controllable endemic reality.”

Dr. Joel Bloombergclinical associate professor of pediatrics at the University of Houston College of Medicine, explained that the vaccine can reduce the risk of infection and provide key protection against serious illnesses and hospitalizations for children.

Additionally, children who become sick can then spread the disease to others, prolonging the pandemic.

“Many children are still becoming ill with COVID-19 and can potentially be acting as vectors to others, such as school teachers and grandparents, who may have conditions which put them at risk for a more serious infection,” he said.

“Being immunized can keep kids in school, protect their families, and decrease spread in their community,” Bloomberg said.

For parents who plan to get their child over the age of 5 vaccinated, experts had advice on what to expect and how to prepare children.

Mary Ann KliethermesPharmD, director, Medication Safety and Quality, American Society of Health-System Pharmacists (ASHP), said parents can help explain the vaccine to kids so that they aren’t afraid.

A parent should begin by telling their child that the shot is to help keep them healthy and “protect them from a disease called COVID that can make children and adults sick,” said Kliethermes.

Kliethermes suggests some ways to relieve a child’s stress, like telling them they’ll receive a “quick little poke” or that it helps if they sit still like a statue.

“Or have them bring their favorite stuffed animal to hug and help them be brave,” she said.

Kliethermes said that during clinical trials, no cases of myocarditis occurred in children ages 5 through 11 years who received the vaccine.

But there are potential side effects that parents should be aware of.

“There may be pain, redness, and swelling at the injection site,” she said. “Children may also experience tiredness, headache, muscle pain, chills, fever, and nausea.”

Kliethermes added that for babies, this might show as irritability, decreased appetite, and lethargy.

Asked where parents can get their younger children vaccinated once approval is granted, Kliethermes said it would likely vary across the country and depend on state and local implementation plans.

She explained that this is the same process that’s been used for the COVID-19 vaccine for the 5 to 11 age group, where each state, tribe, and territory received allocations of vaccines and developed its own plan for distributing the vaccine to those residing in their jurisdiction.

“The federal government added pharmacies, community health centers, and tribal distribution to make sure the vaccine has equitable distribution,” Kliethermes said.

She pointed out that 60 percent of children in the 6-month through 4-year age group live in underserved areas.

“So, a greater distribution to those groups that can reach these areas such as community health centers, health systems, pharmacies, large physician groups is likely,” Kliethermes said.

The Centers for Disease Control and Prevention (CDC) announced its plan to distribute millions of COVID-19 vaccine doses for younger children, but the Food and Drug Administration (FDA) abruptly canceled a vote on authorization planned for Feb. 15.

According to the FDA, the agency has decided to wait on more data from Pfizer before making a decision. Experts say once the drug is approved, distribution will be similar to that used for children 5 and up.

They also say that vaccination for children under 12 is critical to end the pandemic and prevent severe disease in that age group.