Atlanta, GA — Pfizer announced on Monday, Sept. 20, that a clinical trial showed its vaccine is safe and generated an immune response in children ages five to 11.

The results released are the first results for this age group for a U.S. COVID-19 vaccine, and data has not yet been peer-reviewed or published. Pfizer plans to submit the data to the U.S. Food and Drug Administration for emergency use authorization soon, CNN reported.

The trial included 2,268 children ages five to 11 who received two doses of 10 micrograms of the Pfizer vaccine, said Dr. Evan Anderson, a pediatric infectious disease expert and physician at Children’s Healthcare of Atlanta.

Anderson is also an associate professor of pediatrics and medicine at the Emory University School of Medicine. He is the study site principal investigator for the Pfizer pediatric trial. He additionally served as a principal investigator for several phases of the Moderna COVID-19 vaccine adult clinical trial.

“This is the same vaccine that’s used and available for children 12 and above, and as well for adults, but it is one-third of the dose that is used in those populations,” Anderson said during a press conference on Monday.

He added that Pfizer noted the side effects seem similar to those 16 to 25 years of age. They also saw similar immune responses to those 16 to 25 years of age. Although, individuals 16 and older received 30-microgram doses of the vaccine.

Pfizer did not report any efficacy data in the initial report, so it is unknown where there were cases of COVID-19 among children enrolled in the study and how those compared to those who received the placebo versus the vaccine, Anderson said.

“They did note that they have not observed any cases of myocarditis, importantly,” he said. “It is an ongoing study and obviously looking forward to hearing more data and hearing more data as that becomes available as they move the data over to FDA.”

A timeline has not been given for when the FDA could grant Pfizer approval, although it has been stated it could be a matter of weeks. For the adult vaccines, it typically took about four weeks from the initial press release to the emergency use authorization being granted.

“It could be on that timeline. It does depend upon the completeness of the data and any additional questions that FDA has,” Anderson said. “So I think it’s important to not speculate too much about timelines. But this is clearly a very important first step, it does confirm that the 10 microgram dose does seem to be the appropriate dose in kids five to 11 years of age.”

Pfizer also expects to have results and data for those younger than five years old in the last quarter of the year.

“So hopefully we’ll have additional data on the six months to four-year olds coming in the near future,” Anderson said.

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