Pfizer COVID-19 Vaccine For Kids Under 5 Could Be Approved Next Month: Fauci

KEY POINTS

Children under 5 would likely need three doses of the COVID-19 vaccine
Children under 5 would receive 3-microgram doses of the vaccine
Pfizer plans to submit data to the FDA in the first half of 2022

Pfizer and BioNTech’s COVID-19 vaccine could soon be approved for use in children under 5, White House chief medical advisor and the nation’s top infectious disease expert Dr. Anthony Fauci said Wednesday.

During a virtual town hall meeting with Blue Star Families, a nonprofit that supports military families, Fauci suggested that the U.S. Food and Drug Administration could approve Pfizer’s vaccine for younger kids in February.

"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," Fauci said.

The infectious disease expert also added that children under 5 would likely need three doses of a COVID-19 vaccine, adding that two shots did not produce enough antibody levels in children ages 2 to 4 during Pfizer’s clinical trials.

Children under 5 are the only age group who are not yet eligible to receive vaccinations, making them vulnerable to COVID-19.

If the shots are approved by the FDA, children between 6-months-old and 4-years-old will receive 3-microgram COVID-19 vaccine doses. In comparison, adults are given two 30-microgram doses of the Pfizer vaccine.

Pfizer’s submission of data to the FDA was delayed due to revisions in the studies to include three doses of the vaccine. The drugmaker now plans to submit data in the first half of 2022 should their three-dose study prove to be successful, the company said in a December statement.

Fauci’s comment comes as hospitalization rates among children are spiking amid the spread of the highly contagious Omicron variant. As of Jan. 8, nearly 8 out of every 100,000 children under the age of 5 have been admitted to hospitals due to COVID-19, according to data from the Centers for Disease Control and Prevention.

Overall, the U.S. has reported 9,452,491 COVID-19 cases among children, which represents 17.8% of all infections recorded since the beginning of the pandemic. Between Jan. 6 and 13, health officials reported 981,488 child COVID-19 cases, representing 21.4% of all infections reported that week, a Jan. 13 joint report from the American Academy of Pediatrics and the Children’s Hospital Association showed.