The Battle Over Boosters: Is Now the Right Time?

Our front desk staff continues to field hundreds of calls each week about booster doses for COVID-19. Up until this past week, the FDA has authorized booster doses only for those who are immunocompromised. This is based on studies showing that those with diminished immune systems typically only mount a partial response after two doses but do reach a higher, more desirable immune response after three. To date, about 2 million Americans have already gotten a third dose, most of them immunocompromised. We are also aware, though, that some people have scheduled their third dose despite their (presumably) healthy immune system.

So, let’s dig deep. Do vaccine boosters help everyone get ahead in this COVID game, or are we putting the cart before the horse? And what (if any) safety concerns should we consider before pulling up our sleeves a third time? So far at ZüpMed, we’ve erred on the side of safety, sticking to the current FDA recommendations because we are not sure what harm would be caused if everyone who wanted a third dose could receive it.

But, is that the right choice?

Is the third dose of a vaccine necessary?

We’ve said before that it is our belief that COVID vaccination will become more like the influenza vaccine schedule, re-evaluating circulating variants and inoculating annually based on those forecasted virulent strains. The flu is mainly a winter season virus, though, and influenza activity in Australia during the winter months there has provided a reasonable (though not always accurate) forecast of what to expect here in our hemisphere six months later.

COVID has proven to be infectious year-round. Vaccine developers have had to study COVID variants based on geography rather than season, attempting to forecast what variant will circulate to the United States, and when. That raises the question as to what the best time is to schedule dosing to maximally protect against COVID infection. Given that COVID is currently a risk all year long, does that signal a need for vaccination more often than just annually?

We don’t have those answers yet, but Pfizer and Moderna both now have data showing that their vaccine efficacy wanes after about 6 months from last vaccination. So, the question now becomes not if a booster dose is needed, but when should we all be lining up?

Open disagreement among COVID experts

Widespread use of boosters is backed by some politicians, but what is the opinion of scientists and healthcare providers? Discussion and disagreement to various degrees in the scientific community is not only normal, but necessary. Questions keep us honest and challenge us to continue looking for better answers.

Thus, disagreement over boosters, especially early in the learning process, should be expected.

Even after almost two years of COVID experience worldwide, there is still much to learn and understand. Currently, the best information about boosters and their efficacy and safety is coming from Israel. Data was published just this week in the New England Journal of Medicine (Bar-On YM et al. NEJM 2021; Sep 15. doi: 10.1056/NEJMoa2114255. Epub ahead of print) where 1.1 million residents over 60 years of age demonstrated a 10-fold reduction of severe illness among those who received a third dose as compared to those who received only two vaccine doses. Another study this week in the British journal The Lancet (reference), though, whose authors included two senior CDC scientists, concluded that there is not enough evidence to recommend boosters for the general population, “in which efficacy against severe disease remains high” (Haas EJ et al. Lancet. 2021 May 15;397(10287):1819-1829).

This past Friday, September 17th, 2021 the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously 18-0 in favor of a third dose for those at high risk of severe COVID infection, including those over 65 years of age. Contrary to what the current administration has suggested, though, the panel’s scientists declined to approve widespread third dose vaccination for the general public. In fact, the 2-16 vote went decidedly in the opposite direction, citing a lack of safety data for the general population, and including rare but admittedly known risks like myocarditis. This might not be a “forever no”, however, as the committee will likely reconvene once more data becomes available. The FDA’s full recommendation should come later this week and the CDC’s Advisory Committee will also soon add comment.

Who qualifies for a booster?

We expect the following to be eligible to receive a booster for COVID-19:

  • The immunocompromised, including people with diminished immune responses from autoimmune diseases, cancer, and other conditions
  • Healthcare workers
  • Others at high risk for occupational exposure

There is some opportunity for interpretation for each of these groups, and this is usually best discussed with your healthcare provider. We believe that frontline workers, for example, such as teachers, and certain infrastructure workers who are continually exposed to people who may be unvaccinated could be included in this last group.

Is Now the Right Time for You?

Public policy is one thing. Here at ZüpMed, however, we pride ourselves on offering a personalized medical experience. Prevention of illness always starts with information, followed by a frank discussion of risk vs. benefit between the healthcare provider and patient. There may be different answers to this booster question, each correct when considered for the individual.

One reasonable approach could be to offer boosters to those who have waning or minimal antibody response since their last immunization or infection with COVID. While obtaining antibody levels on a broad population level may be unrealistic, measurement of circulating antibodies is used to denote the “immunity” of individuals in the clinical vaccine trials. At ZüpMed, we can differentiate between antibody levels from the native COVID virus and those from an immune response from the vaccine. While there are not yet robust studies utilizing this individualized approach, it certainly appears reasonable in select cases. It could allow for boosting early for those who need it most and waiting for others who have evidence of ongoing immunity. This same approach could also help guide decision-making for the patient wishing to be vaccinated after recovering from native COVID infection.

It’s still important to note that this discussion of boosters comes at a time when one-third of the population has not yet received a first dose of vaccine. Despite widespread vaccine availability and safety data, just over 54% of Americans to date are fully vaccinated. Children under 12, of course, can’t yet be vaccinated, although we do expect a recommendation on children aged 5-11 by the FDA as early as October 2021. The trials on kids under age 5, however, may not be voted upon until months later.

Finally, more than 90% of the poorest world countries aren’t expected to reach a 60% vaccination rate until 2023. We believe that we have a responsibility to help curb the global spread by making sure that all Americans have the opportunity to be protected. If you still have questions about vaccines, please call and ask to speak to one of our ZüpMed providers at (901) 701-7010.