To boost or not to boost? UB’s Russo discusses what the new FDA guidelines mean

BUFFALO, N.Y. – The FDA’s approval last week of a fourth COVID-19 shot is injecting additional questions into the conversation over who should get which booster and when.

Thomas A. Russo, MD, professor and chief of the Division of Infectious Diseases in the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, answered questions regarding what the new guidelines mean for different groups depending on age, underlying conditions and other factors.

What is the most important thing people need to know about the COVID-19 shots?

We need to start this conversation by emphasizing that if you are unvaccinated against COVID-19, the single most important thing you can do for yourself and your loved ones is to please, get vaccinated. The unvaccinated have the greatest risk of getting hospitalized, dying and developing “long-COVID.”

If someone is eligible for that third shot (i.e. the first booster) but hasn’t yet received it, the most important thing they can do is to get that third shot. It is unequivocally recommended and significantly decreases your risk of severe disease and death, especially if you are 50 or older, pregnant or have underlying disease(s).

What did the FDA say last week about booster shots?

The FDA approved a fourth shot for people 50 and up who received their third shot more than 4 months ago. They have approved it, but not recommended it. People should use their own discretion in conversation with their health care provider as to whether or not they should seek a fourth shot.

On what data did the FDA base this approval?

The FDA approved the fourth shot based primarily on three studies out of Israel. The first demonstrated that there were no new safety concerns and the antibody levels were restored to what was achieved after the first booster (third shot). The next two studies showed that if you’re 60 or older, a fourth shot (i.e. a second booster shot) of the mRNA vaccine significantly decreases the risk of hospitalization (4-fold) and mortality (by 78%) if someone becomes infected with COVID-19 compared to those who only received three shots. The Israeli study was done at the peak of the omicron wave. It is important to note that the risk of hospitalization and death for those who had received three shots was low.

How strong are those data?

The FDA’s action was based on limited data. Clinicians like myself and other experts welcome additional data and anticipate that more information will become available soon. So, recommendations may need to be fluid as we move forward.

What is your recommendation regarding booster shots for those who are immunocompromised?

Many people who are moderately to severely immunocompromised have already received their second booster or their fourth shot. I recommend that people who are moderately to severely immunocompromised go ahead and get that fifth shot.

What is your recommendation regarding booster shots for everyone else?

Based on the data available at this point in time, my recommendations for those who received an mRNA vaccine from Pfizer or Moderna are:

·       If you’re 60 and older, it’s reasonable to go ahead and get the fourth shot.

·       If you’re 50 to 59, and you have underlying health conditions that make you more susceptible to severe disease, then it’s reasonable to get the fourth shot.

·       If you are 50 to 59 and healthy, but you share a household or interact indoors with no masks with someone who is at increased risk, then you should go ahead and get the fourth shot.

·       If you’re 50 to 59 and healthy, a benefit is predicted, but data are not presently available to define the magnitude of this benefit, if any.

What is your recommendation regarding booster shots for those who received the J&J shot?

If you received two J&J vaccines, or a combination of a J&J vaccine followed by an mRNA vaccine, I recommend that once eligible, you should get boosted now with a third shot that should be an mRNA vaccine.

What if someone had three shots and then got infected with omicron?

If you have had three shots and then became infected with omicron, that is roughly equivalent to getting a fourth shot, so my recommendation would be to hold off on receiving an additional booster at this time.

What is the bottom line on whether or not people should get the fourth shot?

Data support that the benefit of the first booster, i.e. the third shot, is greater than that of the fourth. But there is no apparent downside to getting the fourth shot for those groups delineated above for which there is a small but clear benefit. On a population level, the benefits of a fourth shot are clear, which is why it was approved by the FDA.