As the Biden Administration's booster shot roll out approaches, we have plenty of evidence that the primary COVID vaccines are still very effective, a growing number of experts say, but very little data to justify widespread use of boosters. This kind of open policy debate is exactly what we need.
Study after study (after study after study) has shown that the available COVID-19 vaccines prevent death and severe disease. The shots continue to stop the majority of infections, even when up against a nastier virus in the delta variant. This conclusion was nicely summed up by a team of researchers writing this week in The Lancet:
A consistent finding is that vaccine efficacy is substantially greater against severe disease than against any infection; in addition, vaccination appears to be substantially protective against severe disease from all the main viral variants.
Although the efficacy of most vaccines against symptomatic disease is somewhat less for the delta variant than for the alpha variant, there is still high vaccine efficacy against both symptomatic and severe disease due to the delta variant.
Their conclusion? Booster shots are probably unnecessary for most people, at least for now. “Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” they wrote. Importantly, two of the authors, Philip Krause and Marion Gruber, recently announced their intentions to retire from the FDA after criticizing the Biden Administration's proposed booster rollout.
CDC Director Rochelle Walensky appears to have reached a similar conclusion, arguing on Monday that there aren't enough data to justify widespread boosting. “Other CDC officials working on the pandemic response are equally exasperated by ... what they see as unrealistic expectations from the White House as it tries to shore up public opinion,” Politico reported. 'Science takes time,' a CDC official said. 'I don’t know how many times we have to say this.'”
Spicy political intrigue aside, there are two important points to consider as this dispute unfolds. Unnecessarily rushing boosters to the market, as the Lancet authors concluded, undermines public confidence in the primary COVID vaccines—and, perhaps more importantly, could jeopardize their acceptance of immunization more generally. The upside is that this open debate between powerful political institutions is an excellent development that could lead to better policy and less skepticism of vaccination.
The problem of public trust
I've argued previously that mandating masks and other non-pharmaceutical interventions for fully vaccinated individuals undermines public trust in the very effective COVID vaccines. The Biden Administration's eagerness to fight delta with boosters will likely have a similar effect for two reasons. First, we have ample evidence that the existing shots are highly effective, very little data on the safety and efficacy of boosters for the general population and millions of Americans who have yet to get the initial dose(s) of any vaccine.
The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination.
The fact that the Biden Administration doesn't see a link between its bid to mandate the first round of vaccines for 80 million people and its rush to get boosters into arms is striking confirmation of the Lancet authors' argument. This is a significant oversight, too, because we'd probably be better off with broader primary vaccine coverage than already-immunized individuals getting boosters. As The Lancet authors explained:
The limited supply of these vaccines will save the most lives if made available to people who are at appreciable risk of serious disease and have not yet received any vaccine. Even if some gain can ultimately be obtained from boosting, it will not outweigh the benefits of providing initial protection to the unvaccinated.
There's also a small but real risk that the booster doses could cause adverse reactions at a higher rate than the initial vaccines did. If that happened, “there could be implications for vaccine acceptance that go beyond COVID-19 vaccines,” they added. Imagine what a high-profile skeptic like Robert F. Kennedy, Jr. would do with the revelation that boosters caused unnecessary harm because the FDA didn't properly vet the safety data. It'd be another MMR-autism scandal, except this time, the anti-vaccine groups would be correct.
Open debate leads to better policy
The media has framed this spat between the CDC and White House as something to be lamented. “Senior officials from the White House and the FDA say the CDC is withholding critical data needed to develop the booster plan,” Politico exclaimed, for example. That's true, but it's also encouraging. Federal agencies staffed by experts exist to advise politicians on scientific matters they can't be expected to understand on their own, like the safety of new vaccines.
If a president wants to overstep the data on a policy issue (and they all do at some point), agencies like the CDC have an obligation to explain why that's a bad idea to the administration and the public. As my colleague Dr. Chuck Dinerstein explained earlier this year, citing the EPA as an example, scientists at these agencies know that politics can hinder their work:
It was clear that the EPA’s integrity staff wanted 'politics' out of the process. They noted other allegations that seemed more timely. For example, managers altering 'technical documents without knowledge or input of project scientists' ... They pointed out that flawed review might be due to 'selection of reviewers to influence outcomes … [or] changes in Scientific Federal Advisory Committees to render them less independent and narrow their expertise.'
This isn't to say that executive agencies are consistent defenders of scientific objectivity. They're subject to biases that influence their regulatory decisions, and they have a history of prioritizing politics over evidence. For instance, the CDC altered its guidance on masking in schools to satisfy the whims of teachers' unions, which was only confirmed because of emails released under a Freedom of Information request.
Public health policy debates often devolve into partisan name-calling contests, during which both sides accuse each other of hating grandmas, children, or freedom (or all three). That's unhelpful, but it's not the ultimate problem we face. If all the facts are known to everyone, it's harder to spin them for political purposes. Moreover, the public is less inclined to doubt public health guidance when they know how it was developed.
This dispute over boosters is a great example of how the process should proceed. Let's hope it's the start of a broader trend.