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Pfizer Says Its COVID-19 Vaccine Is Safe And Effective For Young Kids

The FDA will soon analyze the data on the lower-dose vaccine for kids aged 5 to 11.

Posted on September 20, 2021, at 9:53 a.m. ET

Sopa Images / SOPA Images/LightRocket via Getty Images

Lower-dose COVID-19 shots tested on kids aged 5 to 11 look safe and effective, vaccine makers Pfizer and BioNTech announced on Monday.

Results of the clinical trial of the mRNA vaccine, tested in more than 2,200 kids, will soon be submitted to the FDA, according to the companies, which have not yet publicly released their data.

The doses the children received were a third of the size of adult ones, given in two doses spaced three weeks apart. The lower-dose shots prompted strong immune responses close to those seen in teens and adults aged 16 to 25 given the full doses, the companies said. Younger kids experienced few side effects similar to those seen in young adults.

"We are eager to extend the protection afforded by the vaccine to this younger population," said Pfizer CEO Albert Bourla in a statement. Since July, childhood cases of COVID-19 have risen by about 240% in the US, Bourla noted, as a surge tied to the Delta variant of the virus has coincided with school reopenings nationwide.

While it's currently estimated that only around 1% of kids who get COVID-19 will be hospitalized, by mid-August, the number of kids getting hospitalized with COVID per week was nearly five times higher than it was at the end of June, according to the CDC.

The FDA has faced increasing pressure to authorize vaccines for kids. The pharmaceutical firms said they would also submit the results to be published in a scientific journal.

The FDA authorized the Pfizer vaccine for kids 12 to 15 in May, two months after the drug company submitted trial results to the agency. A similar timeline would mean a vaccine for kids aged 5 to 11 could come around the beginning of November.

Pfizer also said that results from the other two younger age cohorts — children aged 2 to 5 years and children 6 months to 2 years of age — are expected later this year.

A BuzzFeed News investigation, in partnership with the International Consortium of Investigative Journalists, based on thousands of documents the government didn't want you to see.