Pfizer Asks FDA to Authorize COVID Vaccine For Young Children Ages 6 Months to 4 Years

Pfizer-BioNTech announced on Wednesday, June 1, that it asked the Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for kids ages six months to four years. Children in this age group are the only ones not eligible for vaccination in the United States.

The FDA will now consider the company's request, which will review the data and grant emergency use authorization for the said young age group later this month, according to NBC News.

The federal agency's advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to convene on June 15 to offer guidance on pediatric doses.

COVID cases rising again in the USA

The FDA could clear doses for the age group within days of getting a favorable recommendation from the advisory committee. The Centers for Disease Control and Prevention (CDC) will still need to sign off on the pediatric doses, as the agency has done for all other age groups.

Wednesday's announcement may relieve parents who eagerly await to vaccinate their littlest kids. Covid-19 cases are on the rise again across the United States, including among children, according to the CDC.

Pfizer's application to the FDA included clinical trial data that found three doses of the jab for the youngest kids were safe and generated a strong immune response. In addition, interim results from the clinical trial showed that the vaccine was 80 percent effective against the omicron variant of COVID-19, though that figure may change as more results come in.

The COVID vaccine regimen is two doses, given three weeks apart, followed by a third dose administered at least two months later. The shots for children are three micrograms each, one-tenth the dosage given to adults.

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Moderna looking to get approval for COVID vaccine for kids

Pfizer asked the FDA to authorize a two-dose vaccine for the youngest children in early February. However, an advisory committee meeting to review the two-dose regimen for the littlest kids was postponed after Pfizer said that the two doses did not generate a strong enough immune response in an ongoing trial of kids between the ages of 2 and 5.

Pfizer said back then that it would wait for its data on a three-dose vaccine series before seeking authorization from the FDA. Moderna submitted its application for a two-dose COVID vaccine regimen for children under six years old at the end of April. The pharmaceutical giant did say that it expects to seek authorization for a booster dose for the age group.

That vaccine of Moderna is given as two 25-microgram doses four weeks apart, according to Reuters. The FDA's advisory committee will review the company's application alongside Pfizer's at the June 15 meeting. The said meeting will also consider Moderna's emergency use authorization request for youth aged six to 17 years, according to the FDA.

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