FDA official explains decision on ‘simplified’ booster shots
Washington — The US government’s advocacy campaign became much simpler on Friday after Food and Drug Administration officials allowed Pfizer and Modern-19 vaccines for all adults.
It replaces a complex system in which eligibility is based on age, health conditions, and other factors.
“It’s simplistic stuff, I think hugely about the situation we had before,” FDA Vaccines Director Dr. Peter Marks told The Associated Press.
The FDA’s action comes after months of debate among experts over whether everyone 18 and older should get an extra shot at protection.
Just two months ago, FDA advisors dismissed this idea entirely, based on the continued strong performance of vaccines. But the White House has continued to push for wider use to avoid another potential increase. And last week, nearly a dozen states jumped ahead of the Food and Drug Administration to make booster doses available to millions of Americans.
“I think we’re at a point in this pandemic that everyone, including state governors, is getting a little desperate,” Marks said.
The FDA eventually ruled that the additional enhanced protection outweighed the risks of rare vaccine side effects, including cases of heart inflammation, called myocarditis, which often occurs in young adults. This is a different approach than many European countries, which have limited use of Moderna’s vaccine due to signs it has a slightly higher heart risk than other shots.
Marks spoke with the Associated Press on Friday about how the agency makes the decision about the boosters. Conversation has been edited for clarity and length.
Q: The FDA has reviewed the data provided by the companies as well as trends in how the virus is spreading across the United States. How did this factor influence this decision?
A: If you look at the COVID-19 numbers, the seven-day average just this week, it’s up about 15% to 20% – depending on who you’re using. So the trend is not good. People are going inland more and “oops”, next week is going to be the biggest travel week of the year, so it probably makes sense that we do everything we can here to try to turn the tide.
Q: Some experts, including Dr. Anthony Fauci of the National Institutes of Health, have suggested that the use of boosters should have been allowed for all adults months ago. Why didn’t the Food and Drug Administration move faster?
A: We are moving as fast as we can. But we have to do the right analyzes to make sure that when we take action, we can stand behind it. Our goal is to make sure that someone who is on the fence, or perhaps doubts whether to get the vaccine, feels confident enough in our decisions that they are willing to come in and get the vaccine or get the vaccine. We wanted to make sure we had a good justification. And so I think we acted reasonably smart to get that done.
Q: Some European countries have decided not to use the Moderna vaccine in young people due to rare cases of myocarditis. Why did the Food and Drug Administration come to a different conclusion?
A: Some countries have said, “Well, we would not use this vaccine in this age group or it is not a preferred vaccine.” We did our own analysis and for the sake of transparency we put this in the fact sheet (for providers and recipients of vaccines) as some – but not all – studies have shown this side effect. Therefore, health providers should write it down and can make an informed decision about prices, which are not incredibly high. We continue to work to better understand the actual rates.
Q: So what are the risks of this side effect when getting a Moderna booster?
A: The rate of myocarditis for men 18-24 years old is likely to be somewhere between 1 in 5,000 and 1 in 10,000 with Moderna. I can’t tell you the exact number because it depends on the study you’re using.
Myocarditis sounds like a scary word. that it. But myocarditis ranges from a slight — which is basically a lab abnormality — to something really bad while you’re in the ICU. These cases, 98% of these cases, were the really mild form where the most common thing people were given was pain relievers like acetaminophen. We do not exclude this. We still take it as a serious thing. But I’m just trying to say that in terms of the spectrum of side effects, luckily, it’s a moderate result.
Q: So what would you say to a young man who weighed whether or not he was going to get a booster potion?
A: If you are young, you are likely to be at a reasonably low risk of developing severe COVID-19 and ending up in the hospital. You will probably want to prevent yourself from contracting any COVID-19, because even if you are vaccinated and infected, you still have the risk of contracting COVID for a long time.
This is for you, but there are also those around you. We think vaccination reduces the risk of spreading COVID-19, and that’s a good thing too. So I would encourage people to help protect themselves from COVID-19, which can be linked to the prolonged COVID illness and to protect others around them, especially as the holiday season approaches.
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