Washington (AP) — The US government booster campaign has become much easier on Friday after Food and Drug Administration officials have approved Pfizer and Modana’s COVID-19 vaccine for all adults.
It replaces a complex system where eligibility was based on age, health, and other factors.
“This is a simplification, and I think it’s a lot better than before,” FDA Vaccine Director Dr. Peter Marks told The Associated Press.
The FDA’s action will take place after months of discussion among experts on whether everyone over the age of 18 needs to take additional shots for protection.
Just two months ago, the FDA’s own adviser categorically rejected the idea, based on the continued good performance of the vaccine. However, the White House continued to seek broader use to avoid another potential surge. And last week, nearly 12 states jumped ahead of the FDA to make booster shots available to millions of Americans.
“I think we’re at the point of this pandemic where everyone, including the Governor, is a little desperate,” Marks said.
The FDA finally determined that additional additional immune protection outweighs the risk of rare vaccine side effects, including cases of heart inflammation called myocarditis that occur primarily in young men. This is a different approach than some European countries that have restricted the use of Moderna vaccines due to signs of slightly higher heart risk than other shots.
Marks talked to AP on Friday about how the agency made the booster decision. The conversation was edited for clarity and length.
Q: The FDA looked at trends in how the virus spreads throughout the United States, as well as data submitted by businesses. How did it influence this decision?
A: Looking at the COVID-19 figures, this week’s 7-day moving average has risen by about 15% to 20%. This depends on the number you use. Therefore, the direction is not good. People go in more and “oops”, and next week happens to be the biggest travel week of the year, so it makes sense to try to turn the tide with whatever you can do here.
Q: Some experts, including Dr. Anthony Fauci of the National Institutes of Health, suggested that boosters should be approved for all adults a few months ago. Why didn’t the FDA move faster?
A: We move as fast as we can. However, proper analysis needs to be done to make sure that you can stand behind it when you take action. Our goal is our decision that those who are on the fence, or perhaps wondering whether to vaccinate, are willing to come with them to vaccinate or take boosters. Is to make sure you are confident enough. We wanted to make sure there was a good reason. So I think we acted reasonably agile to achieve this.
Q: Some European countries have decided to oppose the use of the Moderna vaccine in adolescents for rare cases of myocarditis. Why did the FDA come to different conclusions?
A: In some countries, “OK, this vaccine is not used or recommended for that age range.” We did our own analysis and put it in a fact sheet (for vaccine providers and recipients) for transparency. Some, but not all, studies have shown this side effect. Therefore, there is something that healthcare providers should be aware of, and they can make informed decisions about rates that are not incredibly high. And we are working hard to better understand what the actual price is.
Q: So what is the risk of this side effect when getting a Moderna booster?
A: The incidence of myocarditis in men aged 18 to 24 years is probably between 1 in 5,000 and 1 in 10,000 in Moderna. The exact number depends on the study you are using and is not known.
Myocarditis sounds like a scary word. is. However, myocarditis ranges from mild (basically mostly laboratory abnormalities) to really severe in the intensive care unit. In these cases, 98% of these were in really mild form, and the most common given to people were painkillers like acetaminophen. We do not reject this. We still take it seriously. But I just want to say that, thankfully, it’s a mild discovery when it comes to the range of side effects.
Q: So what do you say to young people who are considering getting a booster?
A: If you are a young person, you are probably infected with severe COVID-19 and the risk of going to the hospital is quite low. You may want to prevent getting infected with COVID-19, but even if you get vaccinated, you run the risk of getting a longer COVID.
It’s for yourself, but it’s also around you. That’s also good because I believe that vaccination reduces the risk of spreading COVID-19. So I would like to encourage people to protect themselves from the acquisition of breakthrough COVIDs that may be associated with long COVIDs and to protect others around them, especially when entering the holiday season. increase.
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The Associated Press’s Department of Health Sciences is supported by the Science Education Department of the Howard Hughes Medical Institute. AP is solely responsible for all content.
FDA officials explain their decision on “simplified” booster shots | WGN Radio 720
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