FDA Delays Approval of Pfizer COVID-19 Vaccine For Kids Under 5 Years Old [Explainer]

The FDA has stalled Pfizer-BioNTech's approval to allow children below five years old to receive its COVID-19 vaccine.

Vaccines for this age range will not be accessible in the coming weeks due to the decision, which is a setback for parents who want to vaccinate their young children.

The vaccine is not currently available to children under the age of five in the United States, CBS News said. Given the recent increase in child hospitalizations due to the Omicron outbreak, an expert panel was set to convene on Feb. 15 to determine whether children under five should begin receiving Pfizer's vaccine in two doses.

However, the FDA now considers that "further information regarding the continuing investigation of a third dose should be deemed."

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Pfizer Pauses FDA Request for COVID -19 Vaccine for Kids Below 5 Years Old

According to The New York Times, Pfizer requested the FDA postpone giving its vaccine to children below five years old since two doses were insufficient for protection.

Following that, the pharmaceutical business and the federal health department decided to wait and watch before making any decisions. They'll have to wait for the results of a third dosage, which is expected in April, so youngsters under the age of five will have to wait until then to get vaccinated.

Early data from Pfizer revealed that while safe, two low doses of their COVID vaccine did not provide enough protection against the virus for children aged two to four.

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Dr. Peter Marks, chief of the FDA division responsible for vaccine safety, said the abrupt decision to delay the authorization should assure parents that the the health agency makes sure that the vaccine is safe and effective for children.

According to Marks, parents will have to rely on preventative measures to protect their children as they wait for the vaccine to roll out in the coming months. Masking is one of these precautions, ensuring that everyone in the household is eligible is vaccinated.

What Fauci Said Earlier This Year Over COVID-19 Vaccine for Children

In January, Dr. Anthony Fauci, the President's Chief Medical Advisor, predicted that Pfizer's children's vaccine would be approved this month.

"My hope is that it's going to be within the next month or so and not much later than that, but I can't guarantee that because I can't out-guess the FDA," he said during an interview with Blue Star Families.

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention reviewed the potential consequences of both Pfizer and Moderna's injections after many cases of myocarditis following COVID-19 immunizations.

A study obtained by Reuters mentioned that Moderna's two-dose COVID-19 vaccination was linked to a greater risk of heart inflammation than Pfizer's.

The CDC reiterated its "clinical preference for people to get an mRNA COVID-19 vaccination [Pfizer or Moderna] over Johnson & Johnson's COVID-19 vaccine" in a statement made on Dec. 16, 2021.