Pfizer asks FDA to authorize low-dose COVID-19 vaccine for children under 5

A two-dose COVID-19 vaccine regimen for children younger than 5 could potentially be authorized as soon as the end of February, The Washington Post reported late Monday, citing sources “briefed on the situation.”

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According to the Post, Pfizer and COVID-19 vaccine manufacturing partner BioNTech are expected to submit an emergency use authorization request to the U.S. Food and Drug Administration as early as Tuesday that seeks to provide the vaccine to children between the ages of 6 months and 5 years old.

Update 4:42 p.m. EST Feb. 1: Pfizer officially petitioned the U.S. Food and Drug Administration on Tuesday to authorize extremely low-doses of its COVID-19 vaccine for children under 5, The Associated Press confirmed.

If approved, the emergency use authorization could allow the nation’s 19 million children under 5 to start receiving shots as early as March.

Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the omicron wave sent record numbers of youngsters to the hospital, the AP reported.

The Pfizer shots targeting the youngest Americans contain just one-tenth of the dose given to adults and could be dispensed to children as young as 6 months.

Original report: Children under the age of 5 remain the only population segment currently ineligible for the vaccine developed to protect against contracting coronavirus, the virus which causes COVID-19 infections.

Dr. Eric Ball, a pediatrician at Children’s Hospital of Orange County in California, told KCAL that the majority of COVID-19-positive patients his practice is seeing are younger children who are unvaccinated.

“So, I can’t wait for them to be able to be protected. It will really, really be a game changer as far as moving forward from this pandemic,” Ball told the TV station.

The drug companies began testing a third dose within the past few months after the two-shot regimen proved safe but failed to elicit the desired immune response from all age groups. Data on the third dose will not be available until at least late March, however, prompting the current EUA request to get the regulatory ball rolling, the Post reported.

One of the newspaper’s sources, who spoke on the condition of anonymity because they were not authorized to speak on the developments publicly, said it’s an issue of saving valuable time.

“The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in,” the source told the Post.

See The Washington Post’s complete report.

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