The US Food and Drug Administration (FDA) needs more data to decide whether the Pfizer coronavirus vaccine is safe for use in children younger than 12 years of age, acting Commissioner Janet Woodcock said on Monday.
Earlier in the day, the FDA announced it granted a full approval to the Pfizer vaccine, making it the first full-licensed COVID-19 vaccine for use in individuals 16 years and older. “We do not have data on the proper dose nor do we have full data on the safety in children younger than what is in the EUA [Emergency Use Authorization],” Woodcock said during a conference call with reporters.
“We are not recommending that children younger than age 12 be vaccinated with this vaccine, it would not be appropriate.” Woodcock said the vaccine remains available for individuals 12 to 15 years old under the emergency use authorization.
