Atlanta, Georgia – Pfizer announced on Monday, September 20, that a clinical trial has shown its vaccine to be safe and has generated an immune response in children aged five to 11.
The published results are the first results for this age group for a U.S. COVID-19 vaccine, and the data has yet to be peer reviewed or published. Pfizer plans to submit the data to the United States Food and Drug Administration for emergency use authorization soon, CNN reported.
The trial included 2,268 children aged 5 to 11 who received two 10-microgram doses of the Pfizer vaccine, said Dr. Evan Anderson, pediatric infectious disease expert and physician at Children’s Healthcare in Atlanta.
Anderson is also an associate professor of pediatrics and medicine in the Emory University School of Medicine. He is the study site principal investigator for the Pfizer pediatric trial. He was also principal investigator for several phases of the Moderna COVID-19 vaccine adult clinical trial.
“This is the same vaccine that is used and available for children 12 years and older, as well as for adults, but it is a third of the dose that is used in these populations,” Anderson said during a press conference on Monday.
He added that Pfizer noted that the side effects appear to be similar to those aged 16 to 25. They also observed immune responses similar to those of 16 to 25 year olds. However, people 16 years of age and older received doses of 30 micrograms of the vaccine.
Pfizer did not report any efficacy data in the initial report, so it is not known where there were cases of COVID-19 among the children enrolled in the study and how these compare to those who have. received the placebo versus the vaccine, Anderson said.
“They noted that they had not observed any cases of myocarditis, which is important,” he said. “This is an ongoing study and we obviously look forward to hearing more data and hearing more data as the data is transferred to the FDA.”
No timeline has been given for when the FDA may grant Pfizer approval, although it has been said it could be a matter of weeks. For adult vaccines, it typically took about four weeks from the initial press release to the granting of emergency use authorization.
âIt could be on this timeline. It depends on the completeness of the data and any further questions from the FDA, âAnderson said. âSo I think it’s important not to speculate too much about the timelines. But this is clearly a very important first step, it confirms that the dose of 10 micrograms seems to be the appropriate dose for children between five and 11 years old.
Pfizer also expects to have results and data for under-five in the last quarter of the year.
âSo hopefully we’ll have some additional data over the next six months to four years in the near future,â Anderson said.
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