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 ... "
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 important, 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 found that there was overwhelming evidence of safety and efficacy. So much for Finley's assertion that the vaccines "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 new, circulating variants — there isn't time to mount huge trials to demonstrate prevention of infection and/or serious disease.
So, instead, the vaccines are tested in animal models — vaccinated and unvaccinated animals challenged with virus — 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 specific vaccine viruses for 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 works pretty well. (It seems to have worked well this year.)
It's a pity that 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.
The bottom line is that the new round of vaccines have been tested appropriately and, like their predecessors, will likely prevent serious illness, death and undue stress on the U.S. health care system. The more Americans who get them, the better.
Henry I. Miller, a physician and molecular biologist, is the Glenn Swogger distinguished fellow at the American Council on Science and Health. He was the founding director of the FDA's Office of Biotechnology.