COVID Vaccine for Kids Younger Than 5 Could Be Available Soon

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COVID-19 vaccines for children under age 5 could be available by the end of February if shots are authorized in coming weeks.

Pfizer and BioNTech are expected to submit paperwork to the FDA this week — potentially as early as Tuesday — to request emergency use authorization for children between 6 months and 5 years old. Federal regulators have urged the companies to submit an application soon so they can begin to review data for the two-shot process, several sources told The Washington Post.

Pfizer and BioNTech have been testing a third dose for the young age group in recent months. In December, an analysis showed that the two-shot plan is safe but didn’t trigger an immune response for ages 2-4 as strong as the one seen in teens and adults. But the two doses did create a protective immune response for children between ages 6 months and 2 years.

The data on third doses won’t be available until at least late March, the newspaper reported, but Pfizer and BioNTech have been encouraged to submit data to get the review process started. The companies are expected to provide updated data about third doses when they submit the FDA request.

“We know that two doses isn’t enough, and we get that,” one of the sources told the Post. “The idea is, let’s go ahead and start the review of two doses. If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”

A Biden administration official told the newspaper that federal health officials are interested in “seeing this move forward.” On Friday, Pfizer presented updated clinical trial data to federal health officials about the shots, the newspaper reported.

The FDA’s outside advisory group is expected to meet on the two-dose application in mid-February. The CDC’s vaccine advisory group is also expected to meet to consider the data.

The American Academy of Pediatrics said parents with children under 5 are facing “an especially challenging moment in this pandemic.”

“We understand the urgent need for a safe and effective vaccine for that age group,” Mark Del Monte, chief executive of the group, told the Post.

“We are eager to see the data and will continue to follow the science,” he said.

Vaccinations among children who are already eligible has been slow, the newspaper reported, and some health officials are worried that it could be even lower for the youngest age groups.

In areas where shots have been available to ages 5-11 since early November, about 28% of children have received at least one dose, according to a new report from the Kaiser Family Foundation. The vaccination rates varied by state, ranging from about 11% in Mississippi to 63% in Vermont last week.

Sources:

The Washington Post: “Pfizer-BioNTech coronavirus vaccine for children under 5 could be available by the end of February, people with knowledge say.”

Pfizer: “Pfizer and BioNTech Provide Update on Ongoing Studies of COVID-19 Vaccine,” Dec. 17, 2021.

Kaiser Family Foundation: “Update on COVID-19 Vaccination of 5-11 Year Olds in the U.S.”

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