DETROIT – On Monday, Pfizer announced its clinical trial showing that its COVID vaccine is safe for children ages 5 to 11. Pfizer also said it generates a strong antibody response.
Health officials are still waiting on the full results from the clinical trial to be released. The data has not been peer-reviewed or published.
The summary was released on Monday and health officials said it’s encouraging, especially as pediatric COVID cases are rising across the country.
Pfizer’s clinical trial included 2,268 children ages 5 to 11. Two-thirds of the children received two doses of the actual vaccine three weeks apart and the rest received two doses of a saltwater placebo.
On the Today Show, Pfizer explained how they arrived at the appropriate dose for children. Dr. Bill Gruber is the Pfizer vaccine clinical research and development senior vice president.
“We looked at several doses early on in children and determined that one-third of the adult dose works just right for children to minimize the potential side effects and provide the potential for protection,” Gruber said.
Unlike the adult trials, researchers didn’t follow the children in each group to see how many got COVID. Instead, they looked at the level of antibodies they produced after being vaccinated. They found the level matched those found to protect against COVID in those age 16 and older.
Side effects were similar to those seen in teens and adults, including fever, headache, and fatigue. Pfizer said children who received the one-third dose showed fewer side effects after the second dose than in older age groups.
Pfizer plans to submit the data to the FDA by the end of September. The FDA will then need several weeks to review it and present it to its outside panel of advisors before an emergency use authorization could be granted.
Pfizer said the data on children ages 6 months to 4 years old are expected before the end of the year.
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