In a meandering tweet thread, the commissioner also cited unspecified "preliminary epidemiological findings" that "point to the distinct possibility of the bivalent vaccines and antivirals reducing risk of long Covid."
Johns Hopkins medical professor and National Academy of Medicine member Marty Makary and University of California San Francisco epidemiologist Vinay Prasad accused Califf of making statements that pharmaceutical companies themselves can't legally make.
"If Pfizer tweeted this (instead of the FDA Commissioner), they could be fined for false advertisement," Makary tweeted. Califf is "essentially serving as a marketing arm of Pfizer" and peddling "essentially a lie," Prasad wrote in his newsletter.
Bivalent U.S. vaccines, which combine the outdated Omicron BA.4/5 subvariants and Wuhan strain, have "no relevant clinical data in human beings," much less for long COVID, he said. The Paxlovid claim is based on "poorly done observational studies that conflate ICD-10 codes with long covid symptoms and make bold, unsupported claims."
Void of appropriate appraisal skills, and RCTs to support his claim. It’s clear, Pfizer now has two arms, @DrCaliff_FDA, and @WhiteHouse
— James Cintolo, RN FN CPT 🏥🩺 📷 🎙️ (@healthbyjames) November 15, 2022
I can’t believe I have to say this. There are no good data to show antivirals or bivalent vaccines ameliorating harms from long covid. https://t.co/7Yhqwzodrl
While the commissioner blames unspecified scientists for stoking skepticism of the new bivalents and Paxlovid, Pharma Intelligence writer Sarah Karlin-Smith told Califf to look in the mirror.
"[M]any scientists, doctors and members of the public have valid questions about the products due to research holes," she wrote, which "exist in part because FDA authorized the products without requiring the sponsors to address the questions and in some cases still isn't requiring additional research on the topics."
Karlin-Smith said the agency didn't respond to her questions about "whether it is fair for FDA to draw conclusions and authorize a product on lesser data but then urge caution from others in interpreting preliminary information," or to discourage discussion of "new information on an FDA authorized product whose adoption is being so widely encouraged."
so when exactly is and isn't it ok to talk about preliminary data? https://t.co/AhG3tbeSsu https://t.co/yg891rkw0z
— Sarah Karlin-Smith (@SarahKarlin) November 14, 2022