Pfizer Says Its COVID-19 Vaccine Is Safe And Effective For Children 5 To 11 Years Old

By Rachel Elbaum - NBC News

Pfizer and BioNTech laboratories said Monday that the two-dose COVID-19 vaccine is safe and shows 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, stated in a press release that the vaccine is

"safe, well-tolerated, and exhibited a strong neutralizing antibody response"

to it. age group.

No coronavirus vaccine has yet been licensed or approved for use in children under 12 years of age.

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According to Pfizer-BioNTech, the children in the trial received two smaller doses of the vaccine than those given to people 12 years of age and older.

Antibody responses and side effects occurred in the children who were compared to those in a study of people aged 16 to 25 who received the full dose of the vaccine.

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More than 466 million doses of the COVID-19 vaccine have been administered in the United States, according to the Centers for Disease Control and Prevention (CDC).

The vaccine developed by Pfizer-BioNTech is one of three used in the US, along with Moderna and Johnson & Johnson.

About 12.7 million children under the age of 18, or about 54% of youth ages 12 to 17, have received at least one dose of the coronavirus vaccine, according to an analysis of CDC data by the American Academy of Pediatrics (AAP) through September 15.

Pfizer-BioNTech COVID-19 vaccine at a hospital in Providence, Rhode Island, on December 15, 2020.AP Photo / David Goldman

In August, the AAP recommended that the vaccine not be given to children under 12 years of age until it is cleared by the Food and Drug Administration (FDA).

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Pfizer-BioNTech will now submit the trial data to the FDA for emergency use authorization.

They are also testing the vaccine in children under the age of five and expect the results of that trial by the end of the year.

Pfizer first applied for emergency use authorization for its adult vaccine in November and it was approved in December. In August, the FDA granted full approval to the two-dose vaccine for ages 16 and older. It was the first coronavirus vaccine to overcome this latest bureaucratic hurdle. Currently, the vaccine is administered to children ages 12-15 under FDA emergency use authorization.

The news comes as COVID-19 cases have risen in the United States in recent months.

Nearly 5.3 million children in the U.S. have been infected since the pandemic began

, or about 15% of all cases as of Sept. 9, according to the AAP.

That week alone, more than 243,000 cases were added, the second highest number of childhood infections recorded in a week since the start of the pandemic.

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Concerned about the increase in cases in children, the AAP director wrote to the FDA in August to work "aggressively" on licensing a vaccine for children under 12 years of age.

Johnson & Johnson and Moderna, whose doses are used in the United States, are also investigating the effects of their Covid vaccines in pediatric trials.