This guest essay has been updated to reflect news developments.
Last year, many Americans (including me) despaired when the Trump administration’s policy around Covid vaccines veered away from science and the advice of public health experts. Now, the Biden administration risks undermining America’s already fragile trust in the institutions of public health.
The administration recently announced that it was recommending that most Americans who got the Pfizer or Moderna Covid-19 vaccine receive a booster eight months after receiving their second shot. It released a statement from public health and medical experts in the Department of Health and Human Services who agreed that beginning the week of Sept. 20, many Americans should start receiving third vaccinations.
That’s not how these things typically work. Usually, data for making such decisions would be made public first. Then, independent bodies that advise the Food and Drug Administration would review the data and make recommendations. Then, the F.D.A. would review the data and the advice from its advisory panel, and issue an emergency use authorization for boosters as it has for Covid-19 vaccines in general.
Yes, the F.D.A. could move faster. It took far too long for the agency to give full approval for a Covid-19 vaccine, and it still has done that for only one of the shots. It has also taken too long to authorize the vaccines for use in young children, which has complicated the opening of schools. Nevertheless, the solution is to change the way the F.D.A. does its job, not to do an end run around it.
Announcing the policy direction before any of the organizations had weighed in was frustrating. Two of the F.D.A.’s top vaccine regulators resigned, apparently in part because they did not believe that boosters were warranted yet and they did not appreciate having their usual authority undermined, as The Times reported.
The biggest issue is that, unlike the efficacy of vaccines in general, the efficacy of boosters is relatively unclear. The data used for the advisory meeting was released on Wednesday. Much of it comes out of Israel, but those data sets are open to a variety of interpretations. People who were vaccinated early tended to be older, richer and more educated, and when you control for those factors, a lot of the evidence for waning immunity from vaccination gets weaker.
Other data released by Kaiser Permanente also point to increased infections among the vaccinated over time. A study published in The New England Journal of Medicine on Wednesday argued that boosters increased protection against infection and severe disease but studied only people age 60 and older in Israel and only for a relatively short time.
Another study from Public Health England, which has not yet been peer-reviewed, shows that while protection against infections may wane among people who received the Pfizer vaccine, that problem is mostly limited to people age 65 and older. Protection against severe disease, which is most important, doesn’t appear to decline much. This seems clear even to the F.D.A. scientists who prepared the report released Wednesday. They wrote, “Overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States.”
A group of scientists from around the world, including the two who recently resigned from the F.D.A., published a review in The Lancet on Monday arguing that boosters should not be offered to more people at this time. They believe that, as long as supply is still limited, the United States and the rest of the world should focus on getting the unvaccinated vaccinated. The World Health Organization concurs, asking wealthy countries to hold off on booster shots for healthy patients until at least the end of the year.
The panel met on Friday, and the votes likely did not go as the administration planned. It voted against recommending broad authorization of Pfizer booster shots for those 16 and older who are six months out from vaccination. It voted unanimously to recommend authorization for those 65 and older or those who are at high risk for severe Covid-19. It also polled unanimously (although unofficially) to include health care workers and those at occupational risk for exposure in that authorization.
While the F.D.A. is not bound by the advisory panel’s guidance, the agency usually follows it. Even if the F.D.A. authorizes boosters, the final decisions on whether and how to use them widely will come from the Advisory Committee on Immunization Practices, which reports to the Centers for Disease Control and Prevention. That committee has already recommended boosters for immunocompromised people.
Unfortunately, many Americans had heard boosters are coming. I know a fair number of people who have already gotten them in anticipation. Many Americans may be confused by this vote. Many of them will be angry.
To do better, the F.D.A. and the Biden administration need to be clearer in their communication. The most important thing would be to clarify the goals of a booster plan, should one be put in place. If the main reason to vaccinate is to reduce Covid-19 to a more manageable respiratory virus, one that causes far less hospitalization and death, boosters might be continued for the immunocompromised and considered for the elderly but may not be needed yet for most people.
If the goal is to prevent all breakthrough infections, then boosters may be necessary for everyone. But reaching “Covid zero” is likely an unattainable goal, with or without boosters, even if it were defensible.
In the future, if further boosters are recommended, the medical community and the American public will need to know for whom. We will need to know for which vaccines. We will need to know what the criteria are for determining further boosters in the future. We will need to know when diminishing returns will be considered too small for the risks that may arise. We will also need to know how boosters fit into vaccine mandates. Will they be required, and for how long?
If the Biden administration wants to avoid undermining the very process it seeks to strengthen, it must keep pace with the science, not get ahead of it.
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