Dr. Anthony Fauci has promising news for parents of babies and young kids: the White House chief medical advisor said the Food and Drug Administration could approve Prizer's coronavirus vaccine for children under 5 by 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," Fauci said during an interview with a nonprofit group on Wednesday.
This update to the timeline comes just over a month after Pfizer and BioNTech announced that their two-dose regimen failed to trigger an effective immune response in kids two to five years old. (Although the vaccine did generate an adequate immune response in children six months to two years old, the companies reported that two doses of the pediatric vaccination – at 3 micrograms each, they are one-tenth of the adult dose – was not as robust in 2-, 3-, and 4-year-olds as compared to people 16 years and older.)
Back in mid-December, Pfizer announced that instead of testing a larger amount of micrograms per dose in the two-to-five age range, they planned to introduce an additional dose. They then began modifying their clinical trial to include a third shot at least two months after the second dose. Fauci affirmed this development by saying this younger age group will likely need three doses.
This new round of testing caused a delay in submission of data to regulators to authorize use in the U.S., but Pfizer says they expect to file results to the FDA in the "first half of 2022," barring the success of the trials.
"The study will now include evaluating a third does 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," the companies said in a statement, noting they did not identify any safety concerns with this new regimen.
To date, the FDA has authorized the Pfizer vaccine for emergency use in children five years and older.