We have been interested in COVID-19 vaccine booster messaging questions since the early days of COVID-19 vaccines – interested in the technical question of whether boosters were likely to be needed in response to waning antibodies or new virus mutations; and especially interested in the risk communication question of what prospective vaccinees should be told about the prospect of more vaccines to come. Our interest peaked after July 8, when the first western pharmaceutical company, Pfizer, went public about evidence of waning antibodies and its plan to apply for a booster Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). By then Israel and the United Kingdom were starting to discuss booster plans for their most vulnerable citizens, and other countries were publicly looking into doing likewise.
But the U.S. government response to the Pfizer announcement was a “pushback” statement issued jointly by the FDA and the U.S. Centers for Disease Control and Prevention (CDC). It was clear to us that the CDC and FDA didn’t want to talk about boosters, and didn’t want Pfizer to do so either.
On July 22, the CDC’s Advisory Committee on Immunization Practices discussed whether it might be wise to offer an additional vaccine dose to immunocompromised Americans, and we finally wrote our “booster risk communication notes” into this column.
We have four main objections to the way the CDC and FDA (and the U.S. public health profession at large) have reacted to the prospect of COVID-19 boosters – and specifically to Pfizer’s recent announcement 
that boosters might be called for six to twelve months after people’s two initial doses.
Manufacturing a conflict that wasn’t there
On July 8, Pfizer issued an announcement that both real-world data from Israel and its own data suggested that a third “booster” dose of its COVID-19 vaccine might add significant value within six to twelve months of the first two doses. Pfizer said it would therefore soon be submitting to the FDA an Emergency Use Authorization application for the booster.
Within three hours of the Pfizer announcement, the CDC and FDA issued a joint statement to the effect that there was insufficient evidence so far to justify boosters now. The unusual joint statement was clearly meant to be portrayed by the media as pushback, and that is how the media played it.
We were disgusted by this false dichotomy. Pfizer was talking about submitting data within weeks to inform an FDA decision about potential future use of a booster. This is entirely compatible with the CDC/FDA position that a booster is not needed now. Yet the media covered this apples-versus-oranges issue as if the CDC and FDA were actually rebutting what Pfizer had said.
Pfizer: “We have data suggesting it might be needed at some point.”
CDC/FDA: “There isn’t convincing proof that it’s needed now.”We hate the agencies’ insistence on framing their response to the Pfizer announcement as pushback, as if it were somehow inappropriate or even a conflict of interest for a vaccine manufacturer to anticipate future demand and make its own decisions about formulation, production, and when to apply for a revised Emergency Use Authorization – and to be transparent about its rationale for those decisions. There is zero conflict between Pfizer saying it has evidence suggesting that some people may “need” (have use for) a booster six to twelve months after their first two shots versus FDA/CDC saying the evidence so far is insufficient to support the conclusion that people “need” (have use for) a booster now.
Understating the likelihood that boosters are in our future
Neither the CDC nor the FDA has ever denied that there may be COVID-19 boosters in our future. But the likelihood has never been among their talking points. It seems clear to us that they would prefer to see the booster future discussed as little as possible – which is presumably why they tried to make it look like Pfizer was somehow misbehaving even to raise the issue.
The agencies come across as terrified that talking about a booster will make vaccine-hesitant people that much more hesitant – make them think the vaccine must not be that good if you need a booster shot so soon; or make them think it’s not worth the effort and risk to get vaccinated the first time if doing so opens the door to being asked and expected to do it again and again.
This is profoundly disrespectful to the public. Whatever misimpressions the prospect of booster shots might engender, the proper response is to explain why those misimpressions are false, not to discourage public awareness of the potential need for a booster. And if the possibility of future boosters discourages some prospective vaccinees from taking the first step, the proper response is to address the concern, not to hide the fact that might arouse that concern.
Hiding the likelihood of boosters is a particularly repulsive “communication” strategy (it’s really a “don’t communicate” strategy) vis-à-vis people for whom boosters are especially likely to prove important. One such group is the millions of immunocompromised Americans who have chosen to get vaccinated, but whose immune systems may have responded suboptimally to the vaccine. They are likely to be first in line for a booster once one is authorized. Another such group is the relatively small number of Americans who chose the “one and done” Johnson & Johnson vaccine, which may be turning out less effective against the Delta variant than two doses of the mRNA vaccines. They may very well be second in line.
After all, priming and boosting – two doses – is quite a common protocol when you haven’t been exposed to a given virus, the way young children are advised to get two flu shots the first year they are vaccinated against flu.
We think the agencies (and the public health profession generally) are objecting not so much to Pfizer’s judgment that boosters may prove worthwhile either in response to variants or in response to waning – but rather to Pfizer’s decision to express that judgment too publicly, thereby undermining the widespread pretense/hope that once you’re vaccinated you’re probably safe for a long time.
Trying to keep the public (especially the not-yet-vaccinated public) from thinking about boosters is foolish as well as dishonest. We probably do have boosters in our futures within the next year or less – and immunocompromised vaccinees and maybe J&J vaccinees sooner than that.
Officials are excessively worried that telling people now that we might need boosters later will undermine vaccine uptake now. And they are insufficiently worried about two other risks:
- The risk that misleading people about boosters now will undermine booster uptake later.
- The risk that misleading people about boosters now will further undermine officials’ already much-damaged credibility.
It is never good risk communication to nurture people’s misconceptions. The boomerang when they learn they were misled is usually far more harmful than candor at the outset would have been.
Pretending that “need” is the right frame for thinking about boosters
The CDC/FDA statement was explicitly framed in terms of whether boosters are “needed” yet – a question the agencies explicitly answered in the negative. In fairness, the Pfizer announcement was also framed in terms of “need” – future rather than current need – and answered the question in the affirmative.
This frame is a serious mistake. It implies that a medical product is either needed or not needed – that the distinction between needed and not needed is dichotomous. It further implies that that distinction is well-defined and universal. In fact it is none of those things.
Precautionary recommendations are almost always framed in terms of risk versus benefit (sometimes versus cost as well) – not need. Whether the benefit exceeds the risk for specific groups of people is the question the FDA must ask and answer before granting an Emergency Use Authorization. As far as we know, the concept of “need” is nowhere in the EUA standards.
Do we need masks? If a critic of facemasks were to claim that “we” don’t “need” masks, mask supporters would rightly respond that this is a misleading frame. Some people are safer to some degree when they and those around them are wearing some sorts of masks.
Similarly, the real question about boosters is who stands to benefit from a COVID-19 booster shot, how much, how soon, with what downsides.
Pretending that boosters are solely a public health policy question
We are most offended by the agencies’ pretense that the booster question should be up to them and them alone, that it is solely a public health policy question.
When and for whom the government should launch a free COVID-19 vaccine booster campaign is indeed a public health policy question. The relative priority to be accorded to such a booster campaign versus donating vaccine to people in poor countries who have yet to receive their first doses is also a public health policy question.
But COVID-19 boosters are also a medical question, which should ideally be decided by the preferences of individual prospective vaccinees on the advice of their doctors.
We understand that off-label uses are not permitted under Emergency Use Authorizations, so Americans will not be legally entitled to make individual decisions vis-à-vis their own boosters until the vaccines are fully licensed. But full licensure is on the way – and the sooner the better for many reasons. It is time or past time to start teaching people that they will ultimately get to decide for themselves whether they think a bit more protection is worth the modest cost and hassle of a booster dose of a safe and effective vaccine.
Copyright © 2021 by Peter M. Sandman and Jody Lanard
