U.S. Food and Drug Administration staff said that Pfizer Inc.’s COVID-19 shot was effective for kids ages 4 and under with no new safety concerns, in a report released ahead of a key meeting of FDA advisers later this week.
The advisers will meet starting Tuesday for two days to discuss mRNA vaccines in kids. Pfizer’s application for clearance in young kids from 6 months through 4 years will be discussed on Wednesday, in conjunction with Moderna’s application to have its shot cleared for kids ages 6 months through 5 years.
According to the staff report, which was posted on the FDA website on Sunday, the “available data support the effectiveness” of the Pfizer Inc.-BioNTech SE vaccine in kids ages 6 months to 4 years.
A lower rate of adverse reactions was seen in trials of the youngest kids, compared with trials of older age groups, the report said. That may be due to the lower mRNA doses used in the youngest kids, the report said.
The available data “do not suggest any new safety concerns,” the FDA report said about the Pfizer shot in the youngest kids.
The FDA staff report for the Moderna vaccine in kids ages 6 months to 17 years old was posted on Friday and also said it was effective in these age groups without significant unexpected side effects.
The FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Wednesday to evaluate data for both vaccines in the youngest kids and hear presentations from the companies and health officials. The group, made up of outside scientific experts, will then make a recommendation on whether to grant authorization for the shots.
The first day of the meeting on Tuesday will focus on the Moderna shot in kids ages 6 to 17. The Moderna shot is currently only cleared in adults ages 18 and up in the U.S., while the Pfizer shot is already authorized for kids ages 5 and older.
An authorized vaccine for the youngest age group would be welcome news to many parents and caregivers who have been eager to give their children protection against the virus. As many pandemic measures have been lifted, such as masking and social distancing, the lack of vaccines has left children under age 5 vulnerable.
At the height of the omicron wave, multiple preschool-age patients were admitted to the hospital due to dangerous COVID-19 infections. Other young children with cancer had life-saving chemotherapy delayed as a result of COVID-19, potentially reducing their chances of a cure.
COVID-19 vaccines for the youngest kids are expected to be rolled out as early as June 21, the Biden administration announced earlier this month. The government has a supply of 10 million doses of vaccines from both Pfizer and Moderna ready to go as soon as the FDA and the Centers for Disease Control and Prevention give the green light.
