Biden administration COVID-19 adviser Anthony Fauci said that the Food and Drug Administration (FDA) will likely make a decision on whether to recommend COVID-19 vaccines for children under the age of 12 in the fall.
Regulators should have data in the coming weeks to see whether shots for children aged 5 and 11 are needed, he told ABC News’ “This Week” on Sept. 19.
“Sometime in the next few weeks, as we get into October, we’ll be able to see the vaccines for children get enough data to be presented for safety and immunogenicity,” said Fauci, director of the National Institute of Allergy and Infectious Diseases, who has conducted hundreds of media interviews since the pandemic began in early 2020.
Fauci has received significant criticism in recent months over whether his agency knowingly provided funding to gain-of-function researchers working at a virology lab in Wuhan, China.
The Centers for Disease Control and Prevention (CDC) authorized vaccinations for children aged 12 and older earlier in 2021. Some school districts, including the one overseeing public schools in Los Angeles, have made it mandatory for children returning to class to get fully vaccinated.
Pfizer CEO Albert Bourla said that the firm, which makes one of the most widely used COVID-19 vaccines in the world, will likely release clinical data on vaccines for children aged 6 months to 5 years in October. COVID-19 vaccine data for children aged 5 to 11 will come sooner, he said.
Federal government health officials have argued that younger children should get vaccinated due to the spread of the Delta variant of COVID-19.
“Currently, there are still trials ongoing, and so the agency has to wait for the company to submit the data for those trials,” FDA vaccine regulator Peter Marks said Aug. 23. “We certainly want to make sure that we get it right.”
On Sept. 17, the FDA’s vaccine advisory panel voted overwhelmingly against recommending booster shots for the general public and instead voted to recommend them to individuals aged 65 and older. During that meeting, a number of scientists expressed concern for booster-associated side-effects among younger people and children.
Dr. James Hildreth, a voting member on the FDA expert panel, said that he has “a serious concern of myocarditis in young people.” Another expert, Dr. Melinda Wharton, said she does “not feel comfortable” with recommending boosters to younger people due to the risk of myocarditis.
Researchers discovered in August that COVID-19 vaccines used in the United States are more likely to land teenage boys in the hospital than COVID-19 itself. When analyzing reports submitted to the Vaccine Adverse Event Reporting System (VAERS), scientists discovered that males between the ages of 12 and 15 without a serious underlying health condition were up to six times more likely to be hospitalized after getting their second Pfizer-BioNTech or Moderna COVID-19 vaccine dose than from a COVID-19 infection.