Will this year’s Covid booster vaccine enter what we might call the annals of failed product launches?
The boosters would be taking their place amid such storied misadventures as the Ford Edsel. Ballyhooed as the car of the future, the Edsel survived only two years from its 1957 debut before Ford bowed to the rebuffs of car buyers and halted production. Then there was New Coke. It lasted only three months after it arrived in 1985 and set off a clamor for the return of the Old. And let’s not forget Bic disposable pantyhose: on store shelves in 1998, gone in 1999.
The Centers for Disease Control and Prevention last week gave an early glimpse of the coverage data, and there was no escaping the impression that the 2023 launch is going slowly, slowly. Uptake among adults as of the end of the Oct. 14 survey period: 7.1 percent; among kids, 2.1 percent. Across all age groups, the figure comes to six percent, as against 24 percent for flu shots.
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It’s no wonder, then, that last week also found Mandy Cohen, the CDC director, at a Philadelphia Walgreens pharmacy. Dr. Cohen was on a national tour to talk up boostering. As she says, these are early days. The winter respiratory disease season is not yet upon us, and there were early glitches in distribution. Even so, she appears to be tempering her forecast when she says a “fair benchmark” would be uptake across all ages, like last year’s: seventeen percent.
That’s success? You might have thought the CDC had just said that these boosters, which are tweaked versions of Pfizer’s and Moderna’s mRNA vaccines and a more recently cleared non-RNA vaccine from Novavax, should be carefully targeted to people who need them.
The CDC’s promotion is directed at everybody walking on two legs and some who aren’t — the recommended cut-off at the young end of the age range is six months. It matters not, according to this guidance, whether people are young and healthy or old, sickly, obese, immunocompromised, or otherwise at high risk. Nor does it matter whether they’ve already had some jabs or gained a measure of naturally acquired immunity from prior infection.
Many voices in the media, academic medicine, and pharmacy do their own prodding. An email blast from CVS: “The updated COVID-19 vaccine is here! Oh, and it’s free” — “free” in a manner of speaking. The bill to the federal government for Covid vaccines exceeded $25 billion as of some time ago. Washington is now passing on more of the cost to private insurers.
Possibly the campaign even benefits from a residue of belief in the outrageously expansive efficacy claim — “You’re not going to get Covid if you have these vaccinations” — that President Joe Biden made on national television a couple of years ago before he himself came down with symptomatic Covid following no fewer than four shots including two boosters.
For Ford, Coca-Cola, and Bic, who had to do their own marketing and persuade people to part with their own money, such advantages would have been the stuff of dreams. True, the Edsel was hideously designed. New Coke was premised on consumer surveys rather than what consumers had shown they liked to drink for nigh on a century. Bic hosiery was fated to be a no-go from the get-go, no matter the image of great legs on the packaging.
So what would explain a booster debacle? Is “vaccine-hesitant” no longer a term of derision?
The boosters would be taking their place amid such storied misadventures as the Ford Edsel.
Maybe it’s news of the mice. Pfizer’s booster clearance essentially turned on a study of antibody levels in 50 mice (150 including control groups). Moderna’s rested on studies in our own species but also looked only at antibody levels without any assessment of clinical benefit.
There exists an argument that testing of annual flu shots is no more rigorous, to which one of several retorts is this: It was pressure from the White House for quick approval of the initial Covid booster for everybody, not of a flu shot, that prompted two senior vaccine reviewers to take their leave from the Food and Drug Administration.
The hesitant have also found that you hardly need be an anti-vaxxer to break from the ranks of authorities who keep plugging one booster after another. Here’s Marty Makary, a surgeon and public-policy researcher at the Johns Hopkins School of Medicine: “The novel Covid booster shot may be warranted for some high-risk patients. But pushing it hard for young and old alike without human-outcomes data makes a mockery of the scientific method and our regulatory process.”
As for the healthy young, was there ever an emergency?
A large study in Britain considered that question by reviewing all deaths in the eighteen-and-under population in the twelve months ending March 2021, a period when Covid vaccines were not yet available to British children and adolescents. The study noted which kids were free of co-morbidities and which weren’t, and counted only deaths due to infection as distinct from deaths merely coincidental to infection. The mortality risk for the healthy, so estimated, was less than one in a million — nine deaths in a population of 12 million. Suicides over the same period in the same population numbered 124.
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This season’s shots are chasing a less deadly strain of the evolving virus than prevailed then. By the CDC’s estimate, boostering a million adolescents including those already in poor health would spare one death at most over six months and nineteen to 95 hospitalizations. Entirely discounted from this calculation is any risk that repeated boosters pose to teenage boys and young men. That risk, of course, is heart inflammation (myocarditis or pericarditis). It appears slight, but the issue is controversial and, it seems, nowhere near resolution.
For instance, a study from Hong Kong published this past summer looked for indications of subclinical cardiac injury (injury without acute symptoms). Although 78 percent of the enrolled adolescents had no symptoms, medical imaging found in 58 percent cardiac changes lasting no less than five to twelve months and indicating “a potential long-term effect on exercise capacity and cardiac functional reserve during stress.” This study was small: 40 kids, mostly boys, mean age of fifteen. The authors were cautious not to draw conclusions — but they said further studies are “undoubtedly warranted.”
Perhaps studies by an R&D powerhouse with greater resources than a Hong Kong children’s hospital? Might that be Pfizer? Pfizer’s revenue last year amounted to 27 percent of the gross domestic product of Hong Kong.
Pfizer and its vaccine partner BioNTech are already on the hook to do several myocarditis studies under post-marketing commitments. So far, the results of one such study, which had a report-completion deadline at the end of last year, have been submitted to the FDA. The agency and Pfizer declined a request for further information.
“I’m proud to join the club,” Dr. Cohen of the CDC has remarked on X (formerly Twitter). The message accompanied a photo of herself, sleeve up, getting boostered.
This month should tell whether many more people seek membership.
Richard Koenig is the author of the Kindle Single No Place to Go, an account of efforts to provide toilets during a cholera epidemic in Ghana.