On Friday, the U.S. Food and Drug Administration’s (FDA) Advisory Committee ruled that booster shots are not recommended for the average person, only those who are 65 and older and those who are immunocompromised or otherwise high risk for a severe case of COVID-19. However, the FDA was only reviewing data from Pfizer, which means if you got your initial shots from Moderna or Johnson & Johnson, you still have to wait to get your booster. As a result, Anthony Fauci, MD, the White House’s chief COVID-19 adviser, recently voiced concern that some people are not following that advice. Even if you are over 65 or high risk, if you’ve been fully vaccinated with the Moderna vaccine or the Johnson & Johnson vaccine, you should not go out and get a Pfizer booster, Fauci said.
During the interview, host Jake Tapper asked Fauci about the people who are going to ignore the FDA Advisory Committee recommendation and get Pfizer boosters anyway. “We are strongly recommending that people do not do that, that they abide by the recommendation,” Fauci said. “I mean, obviously, people are going to do that. It is not recommended. We recommend that people wait until you get to the point where you fall into the category where it’s recommended.”
When Tapper asked if there’s any risk involved with boosting outside of the FDA’s recommendations or if anything “bad will happen” to people who do so, Fauci said, “You know, there’s always a theoretical risk because the studies have not been done to look at the safety and the immunogenicity of doing that right now for everyone. But, I mean, people who get J&J will be coming in asking to get Pfizer and Moderna, etc. Theoretically, if you look at things, it is very unlikely that there’s going to be a risk there. But, scientifically, you don’t want to go by unlikely. You want to have some scientific proof. And that’s the reason why, right now, we recommend that people go by the guidelines according to the FDA approval and the [Centers for Disease Control and Prevention] CDC recommendations.”
Previously, during an interview with MSNBC’s Andrea Mitchell on Aug. 19, Fauci was asked about the risk of choosing to get a booster before the FDA had made its ruling and before the eight-month timeframe President Joe Biden previously mentioned. He explained that going in for an additional dose too early “might defeat the purpose” of the booster if it’s not administered at the recommended interval. “I wouldn’t say [it’s] dangerous, but one of the things that we’ve learned from an immunological standpoint is that if you get a prime and a boost three to four weeks later, you get the maximum effect of a late boost if you give the immune system a chance to mature over a several month period,” Fauci explained.
During an appearance on Face the Nation earlier this month, Fauci said, “We were hoping that we would get both the candidates, both products, Moderna and Pfizer rolled out by the week of the 20th.” However, he said it was “conceivable that we will only have one of them out,” referring to logistical challenges with Moderna’s paperwork.
While Pfizer got their data in in time for the Sept. 17 FDA meeting, Moderna did not. In early September, Moderna completed their documentation for a 50-mg booster on top of the initial two 100-mg shot regimen, noting that in a clinical trial, that dosage raised antibody levels against the now-dominant Delta variant by more than 40-fold. The company completed their paperwork on Sept. 3, but it wasn’t enough time to be considered at the latest FDA meeting.
Since some non-Pfizer recipients won’t be able to get a booster of their same vaccine at the eight-month mark, people are wondering if they should boost with Pfizer instead. On Face the Nation, reporter Weijia Jiang asked Fauci, “If I had the Moderna vaccine and I’m hearing that Pfizer is going to be available come September 20th, is it OK for me to mix and match?”
“No, that’s a good question,” Fauci responded. “We are doing studies right now, which are just what you said, they are mix and match studies. Namely, we’re lining up Pfizer against Pfizer, Pfizer for Moderna and vice versa. Hopefully within a reasonable period of time, measured in a couple of weeks, we will have that data. But right now, we are suggesting and hopefully it will work out that way, that if you got Pfizer, you will then boost with Pfizer. If you get Moderna, you’ll be boosting with Moderna.”
Like Fauci, the CDC and FDA have not recommended a mix-and-match approach to booster shots either, a conversation that came up earlier with Johnson & Johnson, the one-dose vaccine that saw protection wane earlier than the mRNA vaccines from Pfizer and Moderna. “There aren’t enough data currently to support getting an mRNA vaccine dose (either Pfizer-BioNTech or Moderna) if someone has previously gotten a J&J/Janssen vaccine,” the CDC advises on its website. “People who got the J&J/Janssen vaccine will likely need a booster dose of the J&J/Janssen vaccine, and more data are expected in the coming weeks.”
As for Johnson & Johnson boosters, the CDC and the U.S. Department of Health and Human Services (HHS) said in a joint statement on Aug. 18: “Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. … With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”
On State of the Union, Fauci was optimistic that it “is not going to be very long” until boosters are approved for the other two types of COVID vaccines. “We fully anticipate that, within a period of a couple to three weeks, that there will be enough information on the data that will be presented to the FDA by J&J and by Moderna that we’ll be able to proceed and get those data analyzed to be able to move with the booster in those categories,” he said. “We don’t believe it’s going to be a considerable period of time.”