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COVID-19 boosters shots ‘a tough balance’ for FDA, epidemiologists

The Biden Administration announced last week that COVID-19 booster shots will be available by mid-September for those eight months into being fully-vaccinated. But with many Americans still unvaccinated and vaccine access worldwide varying wildly, are booster shots premature? Stat reporter Helen Branswell joins to explain the ins and outs of the decision.

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  • Michael Hill:

    This past week, the Biden administration announced that by September 20th, fully-vaccinated Americans should be eligible to get a COVID booster shot eight months after their second dose. The Food and Drug Administration will have to approve the plan.

    But with millions of Americans unvaccinated and parts of the globe with little to no vaccines at all, some health professionals say a booster shot may be premature. Hari Sreenivasan spoke about that with STAT reporter Helen Branswell.

  • Hari Sreenivasan:

    Helen, when the date came out from the Biden administration, that hopefully by September 20th, there would be a third booster shot, you went out and talked to a lot of epidemiologists, experts in the field. What was their thinking?

  • Helen Branswell:

    I mean, these are people I talk to all the time and have been sort of pinging them regularly to find out what they think about how well the vaccines are holding up. And most of them think that the evidence is still very strong. The vaccines are doing what we really need them to do, keep people out of ICUs effectively. We are seeing breakthrough cases which are unfortunate but not super surprising. It's really hard to make a vaccine against a respiratory pathogen that will stop all infections so that some people can get cold and flu like symptoms is unfortunate, but not surprising. But in terms of the bigger question, are they protecting people from serious COVID illness? In the main, they still are. So a lot of the people I spoke to were like, we don't see that this is the right time to be pulling this trigger.

  • Hari Sreenivasan:

    What sort of evidence are these experts looking for before saying that there needs to be a booster shot?

  • Helen Branswell:

    Yeah, it's a really tough balance to sort of hit. You don't want to give boosters before you need to because there's a global scarcity of vaccine. And if the United States gives a third dose to everyone, that means people elsewhere are going to wait longer. On the other hand, you don't want to wait too long, because if you do start to see fully vaccinated people ending up in ICUs and very sick and even dying in large numbers or even significant numbers, that also is not an end that you want to see. So they're trying to find the right balance. And, you know, it's an ongoing process. They're constantly evaluating data from both the United States and abroad to see what the evidence is saying.

  • Hari Sreenivasan:

    Where is the FDA in this process? Because so many people have been waiting on what does the FDA say? Do they make it approved? Do they create a different category? Is this emergency use? Is this fully approved? Where's the FDA's thinking in a booster shot?

  • Helen Branswell:

    Well, we don't know that yet. Pfizer has filed an application. In fact, on Monday of this past week, it filed an application to FDA for a booster shot. They want to be able to give a third shot in their series. That application is still before the FDA. There isn't really a timeline publicly known on when a decision on that might be made. As you will remember, the FDA is still dealing with the application from Pfizer and Moderna to swing their vaccines over from being used under emergency use to under full licensure, at least for the Pfizer vaccine. That decision is expected sometime next month. But when they are going to decide on a booster dose is unclear. But I don't think that the country can start rolling out booster doses unless FDA rules on this.

  • Hari Sreenivasan:

    Right. So I look at this and say, wait, if the FDA hasn't decided that the booster is necessary, how do you put a date out there saying September 20th we can start giving booster shots?

  • Helen Branswell:

    That is a very good question that I don't have an answer for you. But it was certainly one of the questions that the people I spoke to yesterday.

  • Hari Sreenivasan:

    Are the experts concerned about the kind of moral and ethical repercussions here of countries like the United States or Israel authorizing a third shot for their citizens when the bulk of the planet hasn't seen the first shot?

  • Helen Branswell:

    A lot are. I mean, you have to tease out a few things there. I mean, some of the countries that are using third shots are using them in people who are severely immunocompromised. The United States just went there last week and nobody's arguing that that is an appropriate thing to do because, you know, people who have had chemotherapy recently or who've had a solid organ transplant and are on immunosuppressive drugs, they don't get protection from two doses. And there is some evidence that a third dose will protect some of them. And so nobody is arguing about that.

    But the statement from the administration yesterday said all Americans and that's what I think a lot of people get very concerned because that's a lot of vaccine to suck up. And the country has already used a lot of vaccine. Far more people are vaccinated here than in many countries in the world. And yesterday, the head of the WHO's emergency response program, Dr. Michael Ryan, equated giving third doses in wealthy countries to giving more life jackets to people who already have life jackets when many people don't have any life jackets and are drowning.

  • Hari Sreenivasan:

    Helen Branswell from STAT News, thanks so much for joining us.

  • Helen Branswell:

    Thanks for having me.

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