Pfizer seeks approval for COVID-19 vaccine in kids under 5

According to a Tuesday report from Bloomberg, Pfizer has applied for emergency authorization for its COVID-19 vaccine in kids 6 months to 5 years old. FDA approval could come as soon as later this month. This means young children could be vaccinated more than a month earlier than previous estimates, assuming the FDA and the Centers for Disease Control and Prevention give their approval.

Early Pfizer data has shown a lower-strength version of its vaccine is safe and produces an immune response in younger kids. However, two doses of the vaccine have proved to be less effective at preventing COVID-19 in kids ages 2-5.

Pfizer is working on gathering data on how effective a third dose would be among that age group. According to a person speaking to the Associated Press on the condition of anonymity, the FDA wanted Pfizer to submit its application based on the two-dose data now, and then return for additional authorization once it has the data from the third dose study. That data is expected to be published next month.

The FDA’s push to get Pfizer to seek approval for its vaccine in kids under 5 years old comes as the Administration granted full approval of Moderna’s vaccine on Monday. The FDA did the same for the Pfizer vaccine last August.

“The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved,” Moderna CEO Stéphane Bancel said in a statement. “We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic.”

Public health advocates initially hoped the regulatory distinction would boost public confidence in the shots. But there was no discernible bump in vaccinations after the Pfizer approval. Still, regulators hope the extra endorsement would encourage more people to get vaccinated.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Janet Woodcock said in a statement. “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”