FDA panel endorses Pfizer shots for 5- to 11-year-olds: Experts say it is 'unnecessary, premature and will do more harm than good'

Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention must also weigh in with its own recommendations - but the Biden administration's announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer's request will sail through.

During today's meeting, the Vaccines and Related Biological Products Committee heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.

Pfizer data insufficient, kids' risk of vaccine injury greater than COVID risk, experts say.

Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System.

Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.

Dr. Josh Guetzkow, a senior lecturer at the Hebrew University of Jerusalem, said expanding the EUA to children is unnecessary, premature and will do more harm than good.

There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome that occurred without previous history of COVID infection, Guetzkow said.
 

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