Health

Pfizer Seeking Emergency Vaccine Approval For Infants Following FDA Pressure

(Photo by ERNESTO BENAVIDES/AFP via Getty Images)

Dylan Housman Healthcare Reporter
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Pfizer is requesting authorization for its COVID-19 vaccine to be given to children under five years old after the Food and Drug Administration (FDA) reportedly pressured the company to submit an emergency use authorization (EUA) request.

Pfizer and its partner company BioNTech announced their request Tuesday for a two-dose vaccine to be authorized for kids six months through five years. Children aged five and under are the only group of Americans without an approved vaccine available, and healthy individuals in that age group are among the least likely to face a risk of serious illness or death from the virus.

The FDA’s panel of vaccine experts will meet Feb. 15 to discuss the request. Pfizer initially tested a two-dose vaccine for young children, with a dosage of one-tenth the amount give to adults. However, the two-dose vaccine did not produce a strong immune response in kids aged 2-5, prompting the company to begin trials for a three-dose series that has seen better results.

Full trial results for the third dose aren’t available yet, but Pfizer CEO Albert Bourla said Tuesday that the company was hoping to have the two-dose series approved first so parents could begin the vaccination process before the third booster dose is approved later.

It is unclear exactly what role political pressure from the FDA and the Biden administration played in the decision to go forward with a potential authorization of the two-dose series before trial results are available for the three-dose series. The Associated Press reported Monday that regulators at the FDA were urging Pfizer to request EUA for the two doses so that the vaccination process for young kids could begin as soon as late February.

The Biden administration reportedly made it a priority to speed up the authorization of a vaccine for kids, to keep schools and daycares open and get parents back into the workforce. (RELATED: Legacy Media Becomes Suddenly Open To The Idea Of Abandoning School Mask Mandates)

Children under five have faced little direct risk from the virus. 392 children under age five have died of the virus in the United States, according to the Centers for Disease Control and Prevention (CDC). A number of studies have shown that unvaccinated children still face less risk of severe illness or death from COVID-19 than vaccinated older adults.