'Full on antivax'? FDA chief calls old COVID vaccines useless to juice boosters, stunning doctors
Robert Califf also promoted a study on vaccination's effect on long COVID in kids, apparently without noticing the tables refer to Paxlovid in ages 50 and up. Epidemiologist says commissioner's alleged shilling is "debasing the office."
Four years after the start of the COVID-19 pandemic – which was officially declared over in 2023 – and with current vaccine booster rates well under 10%, the commissioner of the Food and Drug Administration is eager to get more shots in arms of all ages.
But critical doctors and analysts allege that Commissioner Robert Califf is playing fast and loose with scientific research to do it, using his X account to share papers that haven't been peer-reviewed, proofread or even published in full – and ironically promoting vaccine hesitancy in his crusade for boosting.
"Bob Califf is debasing the office of FDA commissioner," University of California San Francisco epidemiologist and clinical-trial specialist Vinay Prasad wrote in his newsletter Thursday.
"He is promoting low quality evidence that the FDA has not vetted" and would not accept for drug approval, according to Prasad, who has repeatedly browbeat Califf for allegedly misleading or flatly false social media posts. "Even worse, at times the commish misinterprets data and spreads misinformation, denigrating the benefits of primary vaccination."
Califf is still getting boosted by AARP, which told its 38 million members in last month's print Bulletin that they should get the new dose even if it's their sixth, not including the two-dose mRNA primary series, because otherwise they're not "fully protected" from new variants. Anyone 50 and up is eligible for AARP membership.
Continuing global research suggests that COVID vaccination and especially boosting is a toss-up at best for populations at low risk from infection, however.
Japanese, American, and U.K. researchers analyzed about 1,000 COVID-asymptomatic adults in one Japanese hospital who got PET/CT scans unrelated to myocarditis before and after vaccines were available, according to a peer-reviewed Radiology study in September.
They found the 700 vaccinated patients had increased "myocardial fluorine 18 fluorodeoxyglucose uptake" – a measure of heart inflammation – in scans up to six months after their second mRNA dose compared to 303 unvaccinated, "regardless of sex, age, or type of mRNA vaccine received." The study also found elevated inflammation in the lymph nodes, liver, and spleen for the vaccinated.
A nationwide Austrian study of previously infected individuals, published last month in the peer-reviewed European Journal of Clinical Investigation, found that relative vaccine effectiveness (rVE) for those with four versus three vaccine doses was negative 24% against COVID death, meaning the more-boosted were likelier to die.
While rVE was 17% against infection, the effect "rapidly diminished over time and infection risk with four vaccinations was higher" all the way through June, 7 months after the start of the study period, according to the researchers.
They include Stanford Medical School epidemiologist, meta-research pioneer and lockdown skeptic John Ioannidis, whose early COVID research made him the target of an allegedly retaliatory Stanford investigation.
It studied how well Pfizer's updated vaccine that targets now-outdated Omicron variant XBB.1.5 protects against three outcomes in infected people: hospitalization, emergency/urgent care visits, and outpatient visits. Three Pfizer scientists are coauthors.
Researchers compared adults in Kaiser's Southern California health system who took the new vaccine with those who didn't, "regardless of prior COVID-19 vaccination or SARS-CoV-2 infection history," between Oct. 11 and Dec. 10, as well as those who took prior vaccines versus those who were unvaccinated.
The adjusted odds ratio for testing positive for XBB.1.5 vaccine recipients versus everyone else, vaccinated or not, was 0.37-0.42 for the three outcomes, meaning around 60% better protection. The researchers found no "significantly reduced risk" for any outcome for prior-vaccine versus no-vaccine recipients.
Thus, the new vaccines provide "significant additional protection" while previous vaccines offer "little, if any, additional protection [...] regardless of the number or type of prior doses received," they wrote.
Califf's X thread touting the paper drew a wide range of jeers, especially his claim that it said anyone without updated vaccination "appeared to be unprotected."
UCSF Medical Center professor Anil Makam called that an "incredibly bad" interpretation. Califf has gone "full on antivax," California hospitalist James Lim mused.
Former Harvard public health professor Michael Mina, now chief science officer for eMed Digital Healthcare, also called out Califf's "unprotected" description while dubbing the entire paper "misleading," in a lengthy X thread.
The idea that the XBB.1.5 formulation is "important" is "total BS and an inappropriate way to read the paper," Mina said. Because the researchers ran the comparison "a median of 30 days" after receipt of the new vaccine, when immune response is "robust" regardless of formulation, all it shows is "the immune system works!"
The preprint didn't account for incidental COVID infections in hospitalization or consider whether the updated vaccine "may have just prevented PCR positivity," Prasad wrote. If its assumption is wrong that "boosted people seek medical care similarly to non boosted people [...] it could skew the entire analysis."
New York Times columnist Zeynep Tufekci, who denied pressuring scientists to walk back their findings on mask effectiveness, dinged Califf's interpretation without naming him. "People are lying when they claim this paper shows old vaccines aren’t working at all," Tufekci wrote in an X thread.
"How can the FDA Commissioner misrepresent the science around immunity so badly?" independent Georgia COVID analyst Kelley Krohnert wrote, wondering whether Califf "doesn't understand [the paper] or if he's intentionally misrepresenting it."
She contributed to a Prasad preprint on basic COVID data errors made by the Centers for Disease Control and Prevention.
"The vaccine has benefits in the 60+ and immunocompromised groups" but "much lower" for younger and healthier people, Louisiana nurse practitioner Erin McCabe wrote on X. The CDC and Califf repeatedly omit these nuances, "which is why no one trusts them & thinks they [are] just Pfizer lackeys."
Califf also claimed just before Christmas, based on a Nature article, that vaccinated children "have a substantially lower rate of Long Covid" than their unvaccinated peers.
The article links to an abstract in the journal Open Forum Infectious Diseases on "post-COVID conditions" in children who were tested for infection weekly for 14 months starting in July 2021. CDC scientists are coauthors of the study, which hasn't been published in full.
Children were "surveyed via self- or parental report" for six months starting in December 2022, nearly a year and a half after testing started. The two-thirds who were vaccinated – more likely to be white or Asian, previously infected and who reported "excellent/very good" health – were 38-47% less likely to report respiratory PCC and other forms than unvaccinated peers.
"Surely you know this study is observational and full of major confounding," Krohnert responded to Califf. "And it doesn't even have the right figures available for people to see" – the tables in the abstract inexplicably refer to PCC in ages 50 and up who took Pfizer's oral antiviral Paxlovid.
"Kids are not randomly assigned to vaccine, so there is likely residual confounding," but neither Califf nor Nature appears to have read the tables or they'd realize they "do not match the paper," Prasad noted. The Paxlovid tables remain on the abstract as of Friday evening, more than a month after it was posted.
The FDA did not respond to Just the News queries to respond to the criticism of Califf's social media practices and whether he noticed the figures in the long-COVID abstract are wrong.
The Facts Inside Our Reporter's Notebook
- Vinay Prasad wrote in his newsletter
- repeatedly browbeat Califf
- misleading or flatly false social media posts
- 38 million members
- they're not "fully protected" from new variants
- peer-reviewed Radiology study
- peer-reviewed European Journal of Clinical Investigation
- allegedly retaliatory Stanford investigation
- Jan. 2 X thread
- Kaiser Permanente preprint
- anyone without updated vaccination "appeared to be unprotected
- Anil Makam called that an "incredibly bad" interpretation
- California hospitalist James Lim mused
- called out Califf's "unprotected" description
- denied pressuring scientists to walk back their findings
- Tufekci wrote in an X thread
- Kelley Krohnert wrote
- basic COVID data errors made by the CDC
- Erin McCabe wrote on X
- Nature article
- vaccinated children "have a substantially lower rate of Long Covid"
- Open Forum Infectious Diseases
- Krohnert responded to Califf