The U.S. Food and Drug Administration relied on a critically flawed risk-benefit assessment to authorize emergency use of Pfizer’s COVID-19 vaccine for children 5-11 years of age.
The U.S. Food and Drug Administration (FDA) on Oct. 29, 2021, granted Emergency Use Authorization (EUA) of Pfizer’s COVID-19 vaccine for children 5 to 11 years of age.
The Centers for Disease Control and Prevention (CDC) went on to recommend Pfizer’s COVID-19 vaccine for 28 million American children 5 to 11 years of age on Nov. 2, 2021.
This week, Pfizer asked the FDA to authorize the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators once they became available in the spring — clearing the way for the agency to authorize a three-shot regimen for the youngest children who can get vaccinated. The vaccine for this age group could be available as early as February.
The FDA and CDC safety surveillance systems have found an increased risk of heart inflammation (myocarditis/pericarditis) following vaccination with Pfizer’s COVID-19 vaccine. This observed risk was found to be highest in 12- to 17-year-old males, particularly following the second dose.