FDA Could Authorize Pfizer’s COVID-19 Vaccine for Kids Under 5 in the Next Month: Fauci

National Institute of Allergy and Infectious Diseases Director Anthony Fauci testifies before the Senate Health, Education, Labor, and Pensions Committee about the ongoing response to the COVID-19 pandemic in the Dirksen Senate Office Building on Capitol Hill in Washington on Nov. 4, 2021. Chip Somodevilla/Getty Images

White House chief medical adviser Dr. Anthony Fauci said on Jan. 19 that the Food and Drug Administration (FDA) could approve Pfizer and BioNTech’s COVID-19 vaccine for children under 5 years old within the next 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 outguess the FDA,” Fauci said during a virtual town hall meeting with Blue Star Families, a nonprofit group that supports military families.

Younger children likely will require three doses of the vaccine, Fauci said, as a two-dose course failed to produce high levels of protection in trials.

The Centers for Disease Control and Prevention (CDC) recommends that everyone 5 years old or older should get a COVID-19 vaccine to help protect against the virus; children younger than 5 are the only age group that doesn’t need to be vaccinated against COVID-19, the disease caused by the CCP (Chinese Communist Party) virus.

However, Pfizer announced in December 2021 that it plans to submit data to the FDA in the first half of 2022 if its three-dose study proves successful.

The company had previously trialed two shots in children between the ages of 2 and 5, but found that the vaccine didn’t produce a significant immune response among children within that age group. Pfizer and BioNTech said they would change their plans and test three doses of their COVID-19 vaccine on children in that age group rather than the usual two doses.

“Following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age,” the pharmaceutical giant stated. “The study will now include evaluating a third dose of 3 micrograms at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.”

Fauci said on Jan. 19 that Pfizer revising the study to include three doses instead of two had delayed the company from submitting its data to the FDA and getting approval for the vaccine in young children.

A representative of Pfizer didn’t respond by press time to a request by The Epoch Times for comment.

Pfizer says they see it as their “civic duty” to develop a vaccine for younger children due to the rise in hospitalizations with COVID-19 among the population.

According to CDC data, roughly 909 children were hospitalized for COVID-19 between Jan. 11 and Jan. 17, an increase from 140 in late November 2021. In total, from August 2020 to January 2022, 93,552 children have been hospitalized with COVID, according to the CDC.

However, Fauci has previously said that hospitals are overcounting COVID-19 cases in children because they are automatically tested when they are admitted, echoing a narrative some skeptics have been pushing for some time.

On Jan. 19, Fauci again reiterated that children are much less likely to get severe symptoms from the virus that result in the need for hospitalization.

“It is true if you want to be perfectly frank and candid about the data, that a child who gets infected is much less likely to get a severe manifestation of COVID,” he told Blue Star Families.

However, Fauci noted that the risk of young children contracting the virus is “not zero.”

“We have plenty of children when you look at children’s hospitals throughout the country, who are severely ill with COVID-19 requiring hospitalization, some even dying.”