One-size-fits-all COVID booster policy undermined by US, UK government research

"No clear difference in the risk for ICU admission or in-hospital death" between vaxxed and unvaxxed, CDC-led study finds.
FDA Commissioner Robert Califf

Repeatedly accused of publishing low-quality COVID-19 studies in-house to justify its policy preferences, the CDC is facing similar scrutiny for a peer-reviewed study its COVID response team published in a Journal of the American Medical Association publication.

Along with two dozen coauthors from other organizations, the agency's team reviewed the first full year of COVID vaccine availability across 13 states participating in the COVID-NET hospitalization surveillance network.

"COVID-19–associated hospitalization rates in unvaccinated adults were more than 10 times higher than in vaccinated persons, a salient finding when many eligible Americans remained unvaccinated," they conclude in the JAMA Internal Medicine study. Boosted people had a 2.5 times lower hospitalization rate than those who stopped with primary series vaccination.

The authors encourage clinicians and public health practitioners to "continue to promote ... all recommended doses," meaning each new booster authorization by age group. 

But the bowels of the paper acknowledge "there was no clear difference in the risk for ICU admission or in-hospital death between vaccinated and unvaccinated persons," likely because the former "may be more vulnerable to severe infection at baseline."

Epidemiologist Allison Krug, a coauthor of a new preprint on COVID booster mandates for young adults that's not yet peer-reviewed, dissected the paper in a Twitter thread Friday that was retweeted by Stanford medical professor Jay Bhattacharya.

The authors excluded hospital admissions for labor and delivery, surgery and mental health, she wrote. "Study does not further distinguish between WITH vs FOR covid" and assumes all other admissions with positive PCR tests — which the CDC has acknowledged catch long-dead infections — are for COVID, Krug said.

The main benefit of vaccination among the hospitalized was slightly shorter hospital stays: 4.3 days versus 4.6 for unvaccinated. 

"Given that vax and unvax equally likely to be admitted to ICU or die, my guess is that residual confounding is partially affecting the 10x difference in hosp rates," Krug wrote, while unvaccinated groups "may also have underlying comorb[idity] or even other infections causing exacerbation of illness."

The study should not be taken "as evidence that vaccination or boosting prevents hosp in young, healthy population with prior SARS-CoV-2 infection," the target of university booster mandates, she said. Corresponding author Fiona Havers didn't respond to queries.

Lawyer Aaron Siri, who sued the FDA to release Pfizer vaccine documents, noted one of the non-CDC authors of the hospitalization study, Emory pediatrics professor Evan Anderson, disclosed receiving "personal fees" from vaccine makers Moderna, Pfizer, Sanofi, GSK and Janssen. "I am sure that did not cause any bias," Siri tweeted sarcastically.

Anderson didn't respond to queries.

Another Twitter user noted the study population was 18 and older, with no further breakdown by age, despite the fact that COVID "severity skews really heavily with advanced age." Krug's coauthored booster preprint estimated it takes 22,000 boosters to prevent one hospitalization in 18-29 year-olds, while causing 18-98 "serious adverse events."

SAEs are getting renewed attention from a paper in the peer-reviewed Elsevier medical journal Vaccine that made waves this summer as a preprint, getting a boost from bestselling author Jordan Peterson.

Reviewing the phase III Pfizer and Moderna mRNA trials, the authors found their vaccines together were associated with an "excess risk of serious adverse events of special interest" of 12.5 per 10,000 vaccinated and 16% higher risk of SAEs in the vaccine recipients. Hospitalization risk reduction from vaccination, by contrast, was only 6.4 for Moderna and 2.3 for Pfizer.

The authors include British Medical Journal editor Peter Doshi, whose Pfizer vaccine trial investigation was throttled by Facebook, and UCLA emeritus epidemiologist Sander Greenland, who wrote an advanced epidemiology textbook and has specialized in "postmarketing surveillance of drugs, vaccines, and medical devices."

JAMA itself undermined the one-size-fits-all case for boosters by publishing a study led by the U.K. Office of National Statistics researchers last week. 

The JAMA Network Open paper reviewed data combining the 2011 Census of England and Wales and electronic health records covering 80% of England. Ages 18 to 100, the study population, had all received primary vaccination and boosters. Their COVID death rate was 0.02%, and median age of death, 85.

"Age was the most important characteristic," with a hazard ratio (HR) of 31.3 for an 80-year-old compared with a 50-year-old. Increased risk was also associated with living in a care home or "socioeconomically deprived area," but not with ethnicity except for a slightly higher risk for Indians compared to whites. 

Krug's analysis echoes arguments by University of California San Francisco epidemiologist Vinay Prasad, another coauthor on the COVID booster preprint, that vaccinated versus unvaccinated comparisons are often apples-to-oranges because the two populations substantially differ apart from vaccination.

Prasad called on his followers Monday to report FDA Commissioner Robert Califf to Twitter for misinformation for claiming the so-called bivalent boosters, which received FDA emergency use authorization (EUA) last month, increase "your chances of being in attendance at upcoming gatherings with family and friends."

"This is just a 100% speculation," Prasad wrote. "FDA would fine Pfizer for saying it, now FDA has joined Pfizer marketing." Bhattacharya piled on, saying Califf was only correct "if you are recommending booster-based discrimination." The FDA didn't respond to Just the News queries about Califf's tweet.

The bivalent boosters, which include Omicron subvariant BA.4/5 genetic sequences, weren't tested in humans before EUA, however. White House Chief Medical Advisor Anthony Fauci recently claimed the feds couldn't wait because people continue to die from COVID.

While The Wall Street Journal reported Sunday that COVID-related deaths remain in the "hundreds" nationwide, it gave the example of AdventHealth system, whose Orlando-area hospitals counted 24 deaths last month.

"Age was the biggest factor," and only one didn't have "serious health problems such as diabetes, chronic obstructive pulmonary disease, heart failure and obesity," the newspaper said.