MINNEAPOLIS — The FDA has signed off on a pair of new COVID-19 booster shots that are designed to provide a different level of protection. In the process, the FDA is also shifting the level of scrutiny the shots receive.
The new shots from Pfizer and Moderna are bivalent, meaning they contain two spike proteins which are designed to better help your immune system target the latest subvariants that are now predominant.
KARE11 Reporter Kent Erdahl spoke to Dr. Bill Morice, President of Mayo Clinic Labs, about who should consider the new booster shots and how the approval process has changed.
Kent: "A lot of people, because of how widespread Omicron and some of the other variants have been, have now had COVID in the last few months. Do they need this?"
Dr. Morice: "We know from looking at the plasma of patients that have been infected with the more recent circulating strains like Omicron and BA.4 or BA.5, that they do have higher levels of antibodies to those. We also know that this virus does not cause really long lasting immunity, so just because you've been infected... if it's been in the past weeks, sure, but if it's been a few months ago, I wouldn't say, 'Well, I should be fine now.' That's just not the way COVID has behaved."
Because COVID-19 can adapt quickly, the FDA actually fast-tracked the new boosters before they were fully tested in humans. Instead, it used a totality of evidence - including data from mice and human trials of similar bi-valent COVID vaccines - in making it's approval decision.
The director of the CDC says waiting for more human trial data could lead to an outdated vaccine at a time when we're at risk of a fall surge. Some in the medical community have questioned that approach and suggest that people wait for more data.
Kent: "Knowing what we know about the process, what would you say about who should, or shouldn't, wait for more information before seeking a booster?"
Dr. Morice: "In terms of who would really want to think about getting it, those who know they are at high-risk for severe COVID are really the ones who should think about it. Especially if they have underlying immune conditions, if they are being treated for cancer. Also, for those that are in community settings where there is going to be crowding in the fall and winter and want to prevent getting COVID. These boosters probably will be more effective at preventing that than the traditional or existing boosters."
Erdahl: "You said the word 'probably.' Why don't we have better information on that now?"
Dr. Morice: "We don't have the clinical data like we have with the prior boosters, to know how much more effective they will be. We do know they elicit a strong antibody response, and we know that they're going to be safe, because they are so similar to what's already proven to be safe, clinically. We don't know how much more effective because we just don't have that data yet."
Some people will respond differently to that. Some will say, "This is the latest science - it's founded on good scientific principal, there's good preliminary evidence - I should go get it." Others will say, "Wait a second, I'm not seeing the same sort of information that I'm seeing with the other boosters and shots... should I wait?" That data will, I'm sure, be forthcoming, but to try and make it available to prevent a fall surge, we're going to learn on the fly, which is not ideal in a medical situation to be sure.
Though not ideal, the strategy is similar to the approach taken for the seasonal flu vaccine, and Dr. Morice says that is a worth keeping in mind.
Dr. Morice: "All I can share with you is how I'm thinking about it. How I'm thinking about it is that this really represents a transition of the COVID vaccine approach to more of what we've seen with the flu. We know what's been circulating, we've created a vaccine that takes that into account, and so I think if people think of it in that way, people might be more willing to get it."
"Again, that's what's been so challenging with this Kent, it's not absolutes. It becomes very much based on your own situation, your own values and your own beliefs."
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