Booster Burn
CDC’s advice is not following the science
THE push to boost every person in the United States has a scientific problem. New data show that vaccine booster efficacy against getting COVID can plummet to 35% with the Pfizer booster and 45% with the Moderna booster just 10 weeks after that third shot.
So will public-health officials recommend boosters every three months in perpetuity?
The public has no appetite for that. Nor do many experts. Antibodies represent one line of defense against early infection, but cellular immunity with B and T cells confers strong protection against severe disease. That’s why tracking antibody levels is a medically imprecise way to study immunity — and why public-health officials must make decisions driven by data.
To be clear, a single booster reduces the risk of hospitalization in older people. But with many vaccines in medicine, robust memory B and T cell immunity is sufficiently achieved after two or three doses, spaced apart properly.
Yet Moderna’s CEO has already suggested annual boosters, with no supporting clinical data. While his shareholders love that news, many experts do not. Dr. Vinay Prasad of the University of California this week nicely summarized the problem with using efficacy as the ultimate metric to evaluate a vaccine.
In a recent Kaiser Southern California study, the efficacy of two doses of the mRNA vaccines went to essentially zero at 6 months, despite a lot of data showing that these same vaccines provide strong protection against hospitalization in younger people.
Yet as many of us predicted, the Centers for Disease Control and Prevention officially changed the lexicon from “Did you get a booster?” to “Are you up to date?” COVID vaccines are not software.
Booster recommendations are nuanced and need to be tailored to a person’s age and health situation. They should be medically precise. That’s the art of medicine.
To date, the clinical benefit of boosters has not been reported in younger people or people with natural immunity from prior infection. In fact, young healthy people have a strong immune system and develop strong immunity from the primary vaccine series. A large Israeli population study published in the New England Journal of Medicine found that the risk of COVID death in a fully vaccinated, non-boosted person under age 30 was zero. A booster cannot lower that risk further. A recent German population study found that no healthy child 5 to 17 years old died of COVID over a 15month period when the vast majority were unvaccinated.
Many of us have been alarmed by the CDC and Food and Drug Administration pushing boosters for young people, despite zero clinical data to support this recommendation and concerns of unintended harm from myocarditis, which can affect as many as one in 1,860 young men, ages 18 to 24.
Booster enthusiasts point to surges in antibody levels after each additional vaccine dose. To date, those increases in older people help activate immunity against hospitalization and death, but in young people, who are intrinsically low risk, they may just be the equivalent of a sugar high.
Scientific discourse on boosters has been corrupted. Two top FDA officials, including the head of the FDA’s vaccine center, resigned over this very issue — political pressure to authorize boosters in young people. Defiant of concern around their departures, the FDA last week chose to bypass its expert advisory committee and authorize boosters for children between 12 and 15 years old. Not putting the issue to a committee vote, as the FDA routinely does, captures how the agency now conducts its business: Pre-set agendas undermine the scientific process.
More concerning, we are moving backwards in transparency. The CDC informed its Advisory Committee on Immunization Practices members that because it asked for 24 days of their time last year, the CDC will do most of the work internally, saying that “we are really hoping this year that we will have a more feasible and sustainable approach to meetings.” In other words, we won’t be meeting much in the future.
Remarkably, despite having 21,000 employees, the CDC is still unable to provide the key COVID statistics we need to inform public policy. The agency has not released data on naturalimmunity reinfections, and chief Rochelle Walensky falsely said on “Fox News Sunday” that with Omicron, “prior infection protects you less well” than vaccination. I’d love to see that data.
Most alarming, two years into the pandemic, the CDC has not been able to tell us how many people are in hospital for COVID versus with COVID. Reports from New York City and Miami Jackson Memorial Hospital are among many finding that the majority of COVID hospitalizations are primarily for other conditions — but when patients are admitted and tested, they’re found to have an incidental COVID infection.
Public-health officials need to shift focus from antibody levels to real-world clinical outcomes data. Otherwise, we’ll be getting a booster every Monday morning when we show up at work.
Dr. Marty Makary is a professor at the Johns Hopkins School of Medicine and author of “The Price We Pay: What Broke American Health Care and How to Fix It.”