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Pfizer Says Vaccine Is Safe for Kids Aged 5 to 11, Will Submit to FDA This Month

The FDA could approve emergency use authorization for the vaccine for young children by the end of October.

A child watches as a nurse administers a shot of COVID-19 vaccine during a pop-up vaccination event at Lynn Family Stadium on April 26, 2021, in Louisville, Kentucky.

Pfizer and BioNTech, two pharmaceutical companies that jointly produced the most widely used vaccine in the United States for protection against coronavirus, announced on Monday that, based on their own studies and data, a two-dose vaccination regimen for children ages 5 to 11 is safe to administer.

In a press release announcing their findings, the companies said the vaccine is “well tolerated” in those it was administered to, and that it “showed robust neutralizing antibody responses” to COVID-19.

The data collected and presented by Pfizer and BioNTech included results from vaccinating more than 2,000 children who took part in a clinical trial. The dosage of the Pfizer-BioNTech vaccine given to younger kids is about one-third of what is being administered to adults and children 12 and older.

Side effects of the vaccine in young children were similar to those found in other age groups. However, myocarditis, one notable (but still rare) side effect seen in a small portion of adult vaccine recipients, did not appear at all in children within the study.

The companies plan to submit the results of their study to the Food and Drug Administration (FDA) by the end of this month. If those same conclusions are agreed upon by the FDA, the agency may grant the vaccine emergency use authorization for children by the end of October.

Although some remain skeptical about having their own kids take the coronavirus vaccines, a surge of COVID infections in children across the U.S. likely means that millions of parents are welcoming this week’s news from Pfizer and BioNTech. COVID vaccines were given emergency use authorization for children 12 and older earlier this year, but younger children have still been at risk of contracting the virus, particularly in places where masking isn’t required inside school buildings.

Children are still less likely to get sick from coronavirus than are older age groups, but that doesn’t mean they’re completely safe from its effects.

Since the start of the school year, kids have made up a significant proportion of the overall population of new cases. According to the American Academy of Pediatrics (AAP), more than 243,000 cases of coronavirus were identified in children during the week ending on September 9 — a number that accounts for close to 29 percent of all cases in the U.S. However, individuals under the age of 18 only account for 22.2 percent of the country’s population.

The number of kids who were diagnosed that week was the second-highest total of weekly childhood COVID diagnoses since the start of the pandemic, with the highest number being recorded just one week prior, when more than 252,000 coronavirus infections were found in children in the U.S.

Nearly 440 children have died from coronavirus in the U.S. since the start of the pandemic.

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