Critics are slamming the Food and Drug Administration's approval of COVID-19 booster shots for children ages 12 to 15 without approval from the FDA's advisory panel.
"It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board ... FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms," Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center and Fox News contributor, tweeted Saturday.
"We're being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value," committee member Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's vaccine advisory committee, told The New York Times last week.
The FDA on Monday authorized the use of a Pfizer-BioNTech booster in adolescents 12 to 15 and shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to five months from six.
Finally, the FDA allowed for a third dose of vaccine in immunocompromised children 5-11 years of age.
Centers for Disease Control and Prevention Director Rochelle Walensky must still weigh in with a recommendation on the announcement before the changes can take effect.
"Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind," acting FDA Commissioner Janet Woodcock, M.D., said in a statement.
Woodcock said it is critical for the public to take "effective, life-saving preventative measures," including booster shots, during the current surge of infections driven by the omicron variant.
Makary called the decision "unconscionable" and said it "undermines the integrity of the FDA's standard process! Please require FDA to put this authorize [sic] before the VRBPAC advisory comm for a vote!"
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