Should a healthy 52-year-old woman with a normal BMI who has had Covid-19 three times and has received six previous doses of a Covid-19 vaccine get vaccinated with the latest update of the vaccine? The question is asked in a New England Journal of Medicine by Dr. Martin A. Makary, Trump’s commissioner of the FDA and Dr. Vinay Prasad, who was appointed by Makary as head of the Center for Biologics Evaluation and Research. Their answer is that this is not known and that therefore they were removing the FDA’s recommendation that healthy individuals between 4 and 64 years of age receive the updated vaccine.  They explain that removing the recommendation will compel manufacturers to conduct the studies that will determine whether this woman should take one of their vaccines, because without proof that they work for her, their sales will be limited because of lack of an FDA recommendation

This is terrible science and terrible public health policy.  The CDC collected data from 6 hospitals from September 2024 to January 2025, and the data show that an 18–64-year-old who has not received the 2024-2025 vaccine has a 55% greater chance of being hospitalized with Covid than a person who has (author’s calculations are here).   It also shows that of the unvaccinated who are hospitalized, 36% – more than a third –would not have been hospitalized (either because their infection would not have been bad enough or because they would not have been infected to begin with) had they taken the vaccine.  (Persons younger than 18 are not included in the discussion here because data about them is not readily available.)  Thus, the vaccine is effective, and in fact anyone in the 18 to 64-year-old age group should get it.

But what about individuals who have already had 6 vaccines and 3 prior infections? Such individuals are rare.  Only 8% of the patients between the ages of 18-65 who were hospitalized for any illness during the CDC study period had been immunized with the 2024-2025 vaccine.  Also, the most recent vaccination of those who were not vaccinated with an updated dose occurred 1,042 days (median), almost three years, before hospitalization.   To stop vaccinations for all because there may be a few individuals who get the vaccine even though they don’t really need it does not make sense and for many people this policy will be fatal.

Although woefully unreported in the news, there were more than 35,000 deaths due to Covid in the last 12 months; one-third of these deaths were people younger than 65.   Ninety-two percent of these, or about 11,000, were unvaccinated. (This assumes that the rates of vaccination among the dead are the same as among the hospitalized.)  As we have seen, 36% of them, or about 4,000 individuals, would not have died had they been vaccinated. In fact, instead of stopping the vaccinations, the FDA should be vigorously encouraging people to get them.

Even if the search for additional data were justified, however, these data could be collected while vaccinations continue. The rate of vaccination is so low, that there is no need to administer placebo in order to know the fate of the unvaccinated.   But instead of the manufacturers doing these studies, it will require that a government agency, perhaps the NIH, will perform them.

In general, there is no reason why manufacturers should be the ones who conduct the testing of drugs that show evidence that they may be effective, either in the lab or based on prior use. It is far better to have the FDA and the NIH, which after all represent the public, conduct the tests.  This would, of course, raise the profits of the manufacturers, but these could be lowered by regulating drug prices.  Testing by the government would remove a prime excuse that manufacturers give for the high prices they charge, and it would also encourage more drug development by making it more affordable for new manufacturers to enter the market.

Good science and good public policy would be for Covid vaccinations to continue, and for their effectiveness, and indeed the effectiveness of all drugs, to be evaluated not by their manufacturers but by the government.

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