Here we go again — another armchair expert holding forth on scientific and medical issues she misunderstands. This time, it's Wall Street Journal columnist Allysia Finley, who characterized the FDA's approval of the newest round of COVID vaccines as being "based on flawed studies and extrapolations."
In a Sept. 17 column, she caviled that, "The FDA last week approved updated boosters based on data showing they generated antibodies and past studies purportedly demonstrating that the original vaccine and earlier booster versions worked. But these are large extrapolations based on flimsy evidence. No placebo-controlled trials have shown the boosters are effective... "
Ms. Finley is wrong in several respects. She fails to grasp that new, updated versions of vaccines based on a previously proven platform are not subjected to large placebo-controlled trials, in part because they're not necessary, but more importantly, because they're not possible.
Why is that? The original COVID vaccines were tested at the height of the pandemic in clinical trials of more than 30,000 subjects each. There were huge numbers of infections occurring throughout the country, so it was not difficult to demonstrate a statistically significant difference in infection rate, hospitalizations, and deaths between the vaccinated and placebo-controlled groups. I read the lengthy summaries of the FDA clinical trials, and there was overwhelming evidence of safety and efficacy. So much for Ms. Finley's assertion that the vaccines only "purportedly" worked.
But now, with the number of cases lower and some urgency about making available the new round of vaccines — which differ only by the substitution of a new spike protein in order to elicit an immune response to the new, circulating variants — there isn't time to mount huge trials to demonstrate prevention of infection and/or serious disease.
Instead, therefore, the vaccines are tested in animal models — vaccinated and unvaccinated animals challenged with virus — to demonstrate prevention of infection, and on a small number of human subjects (without a virus challenge) to show that they develop antibodies and other signs of an immune response and that there are no obvious safety signals.
This is not a process concocted just for COVID vaccines. In fact, it is how seasonal flu vaccines are routinely formulated each year. Meetings of flu experts worldwide take place under the umbrella of the World Health Organization every February to select viruses for the upcoming Northern Hemisphere's seasonal flu vaccines and in September for the Southern Hemisphere's vaccines. They consider global flu data and recommend which viruses should be included in the following season's vaccines. Then, each country makes its own decision about which viruses should be included in flu vaccines licensed in their country.
In the United States, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) makes the final decision about vaccine viruses for the nation's flu vaccines. The relevant data are presented to VRBPAC in February or March of each year for the U.S. decision about which viruses to include in the upcoming season's flu vaccine. The various manufacturers of flu vaccines then begin to produce them, using a variety of technologies, for the next flu season, seven or eight months away. As I mentioned above in the context of COVID vaccines, given the timing and the absence of significant flu activity until the flu season arrives, it is simply not possible to perform sufficiently large placebo-controlled clinical trials for each year's new vaccines.
The experts' guesswork is better in some years than others, but the process generally succeeds. (It seems to have worked well this year.)
It's a pity that Ms. Finley couldn't find anyone to explain all this to her. Instead, she relied on cherry-picked quotes from Vinay Prasad, a renegade anti-vaccine oncologist who has been combative and consistently wrong about the pandemic, and Paul Offit, a prominent infectious disease specialist whose opinion — that not everyone should receive the new COVID vaccines — is not widely shared.
Ms. Finley was not always so misguided. In a December 2021 Wall Street Journal commentary entitled "The Vast Promise of mRNA Technology," this was her opening paragraph:
Are Covid-19 vaccines a failure? That’s the view in some media quarters amid breakthrough infections and new virus variants. It’s also false. Vaccinated people are more prone to mild infections than public-health authorities initially anticipated. But the shots continue to provide strong protection against serious disease, and the mRNA vaccines in particular—Pfizer/BioNTech’s and Moderna’s—are adaptable to new variants.
An ironic footnote: On October 2, the 2023 Nobel Prize in Physiology or Medicine was awarded to scientists Katalin Karikó and Drew Weissman for their "groundbreaking findings" on mRNA vaccines. The Nobel Committee announcement said, in part, “The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times.”
The bottom line is that the new COVID vaccines have been tested appropriately and, like their predecessors, will likely prevent serious illness, death, and undue stress on the U.S. healthcare system. The more Americans who get them, the better.
Note: An earlier, abbreviated version of this article appeared in the South Florida Sun-Sentinel.
Henry I. Miller, MS, MD
Henry I. Miller, MS, MD, is the Glenn Swogger Distinguished Fellow at the American Council on Science and Health. His research focuses on public policy toward science, technology, and medicine, encompassing a number of areas, including pharmaceutical development, genetic engineering, models for regulatory reform, precision medicine, and the emergence of new viral diseases. Dr. Miller served for fifteen years at the US Food and Drug Administration (FDA) in a number of posts, including as the founding director of the Office of Biotechnology.
