‘The fix was in’: FDA adviser’s warning ignored as COVID booster approved for kids

This story was originally published by the WND News Center.

Despite warnings from an FDA adviser of a lack of sufficient safety and efficacy data, the FDA on Wednesday authorized COVID-19 boosters of the updated bivalent vaccine for children 5 years of age and older.

The agency amended its emergency use authorization of the Moderna and Pfizer-BioNTech bivalent vaccines to include children, allowing it to be administered at least two months after completion of primary or booster vaccination.

The FDA adviser who issued the warning, Dr. Paul Offit, was one of two members of the agency’s vaccine advisory panel to vote against recommending the booster shot, which was modified to target omicron variants. Offit, the co-inventor of a rotavirus vaccine, argued that the testing was limited to only eight mice, with no human participation.

“I don’t ever think you should ever ask tens of millions of people to get a vaccine based on mouse data,” he said in a video interview.

Offit – a specialist in infectious diseases, vaccines, immunology, and virology – directs the Vaccine Education Center at Children’s Hospital of Philadelphia, where he is an attending physician in the Division of Infectious Diseases.

He said the only reason he voted against recommending the new booster in the June advisory panel meeting – there were 19 yes votes – was “because ‘hell no’ was not a choice.”

“It just surprised me that we were willing to go forward with such scant evidence of benefit,” he said.

Offit added that he “just felt sort of like the fix was in a little bit here – maybe that’s not the right phrase – but it was something that they wanted.”

“I felt like we were being led here, with a critical lack of information.”

One year ago, several members of the FDA’s vaccine advisory panel said they were reluctantly recommending approval of the Pfizer vaccine for children ages 5-11 despite a lack of safety data.

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