FDA authorizes emergency use of Pfizer COVID-19 vaccine in kids 5 to 11, CDC director could give green light next week

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The U.S. Food and Drug Administration has authorized emergency use of the Pfizer-BioNTech COVID-19 vaccine in kids ages 5 to 11-years-old, which means that children within that age range could potentially be able to receive the shots as soon as next week.

“The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations,” according to the FDA.

The panel is slated to meet on Tuesday to supply recommendations, according to the Washington Post, which noted that after the CDC director gives the green light, providers will be able start giving kids the vaccine shots.

While vaccination for individuals in this younger age bracket will entail two doses separated by 3 weeks, the doses will be lower at just 10 micrograms compared to the 30 micrograms people 12 and older receive, according to the FDA.

“The vaccine's safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study,” according to the FDA.

“The available safety data to support the EUA include more than 4,600 participants (3,100 vaccine, 1,538 placebo) ages 5 through 11 years enrolled in the ongoing study. In this trial, a total of 1,444 vaccine recipients were followed for safety for at least 2 months after the second dose.

“Commonly reported side effects in the clinical trial included injection site pain (sore arm), redness and swelling, fatigue, headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite. More children reported side effects after the second dose than after the first dose. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days,” the agency noted.

The CDC reports that 67.7% of the U.S. population ages 12 and above has been fully vaccinated.

Even if 5 to 11-year-old children become eligible to get the vaccine, some parents will likely choose to not have their children receive the shots.

“According to the CDC, approximately 8,300 COVID-19 cases in children 5 through 11 years of age resulted in hospitalization,” the FDA noted. “As of Oct. 17, 691 deaths from COVID-19 have been reported in the U.S. in individuals less than 18 years of age, with 146 deaths in the 5 through 11 years age group.”

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