The decision marks a shift in the FDA’s approach to the vaccines, which the agency previously approved for everyone 12 and older and, under emergency use authorization, for babies and children ages 6 months through 11 years. The new framework doesn’t completely take COVID-19 vaccines off the table for healthy adults and children, but does require new clinical trials for those groups.
The U.S. Food and Drug Administration (FDA) unveiled plans today to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.
The decision marks a shift in the agency’s approach to the shots, which were previously approved for all people ages 12 and older and, under emergency use authorization, for babies and children ages 6 months through 11 years.
Last week, The Wall Street Journal reported that the Centers for Disease Control and Prevention (CDC), which makes recommendations for FDA-approved medications, plans to stop recommending that pregnant women, children and teens routinely take the COVID-19 vaccine.
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