Pfizer-BioNTech said on Monday that the companies’ two-dose Covid-19 vaccine was safe and showed a “robust” antibody response in children ages 5 to 11.

Based on data collected in a trial that included more than 2,000 children, Pfizer and its German partner, BioNTech, said in a press release that the vaccine was “safe, well tolerated, and showed robust neutralizing antibody responses” for this age group. No Covid vaccines have yet been authorized or approved for use in children under 12.

The children in the trial were given two smaller doses of the vaccine than those given to people 12 and older, according to the release. The companies said that it produced antibody responses, and side effects, in children that were comparable to those seen in a study of people 16 to 25 who received the full dose of the vaccine.

More than 466.5 million Covid vaccine doses have been given in the U.S., according to the Centers for Disease Control and Prevention. Pfizer-BioNTech’s vaccine is one of three currently in use in the U.S.

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Around 12.7 million children under the age of 18, or around 54 percent of 12- to 17-year-olds, have received at least one dose of a Covid vaccine, according to an American Academy of Pediatrics analysis of CDC data as of Sept. 15.

In August, the AAP recommended against giving the vaccine to children under 12 until it was authorized by the Food and Drug Administration. We plan to submit the data before the end of August and then it will be up the FDA to review those data and decide whether the vaccine is safe for wide use.” Dr. Bill Gruber, a senior vice president in vaccine clinical research and development at Pfizer, said on NBC’s Today show. We hope that this will happen quickly. “

Pfizer-BioNTech said they will now submit their data from the trial to the FDA for emergency use authorization. They also tested the vaccine in children below five years old and expect to have results by the end.

Pfizer first applied for emergency use authorization for its vaccine for adults in November. The FDA granted full approval to the two-dose vaccine in August for those ages 16 and up. This was the first time a Covid vaccine had passed this regulatory hurdle. The vaccine is currently given to 12-to-15-year-olds under the FDA’s emergency use authorization.

The news comes as Covid cases have surged in the U.S. in recent months. In total, nearly 5.3 million children in the U.S. have tested positive for Covid since the onset of the pandemic, or around 15 percent of all cases as of Sept. 9, according to the AAP. More than 243,000 cases were added that week alone, the second highest number of child cases recorded in a week since the pandemic began.

Concerned with rising cases in children, the head of the AAP wrote in August to the FDA to work “aggressively” toward authorizing a Covid vaccine for children under age 12.

Johnson & Johnson and Moderna, whose Covid vaccines are in use in the U.S., are also researching the effects of their Covid vaccines in pediatric trials.

Rachel Elbaum is a London-based editor, producer and writer.

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