Experts analyze the process by which the Advisory Committee on Immunization Practices formulates vaccine recommendations and updates them, and the implications and effects of these decisions.
Rodney E. Rohde, PhD, MS, SM (ASCP) CM, SVCM, MBCM, FACSc: Mr Welch, how does the Advisory Committee on Immunization Practices [ACIP] make decisions about vaccine recommendations and updates to those recommendations? In other words, the nuts and bolts. How does the committee meet? How do they update things? How do they release data and information?
Adam C. Welch, PharmD, MBA, FAPhA: It’s an in-depth process for them to look at the evidence for recommendations. They do a grading process. The ACIP will meets routinely 3 times a year, typically in February, June, and October. June is when they talk about influenza. In June 2023, they’ll be making the recommendations for the upcoming 2023-24 flu season. But before they do that, before it comes to the ACIP panel, there are a lot of individuals working behind the scenes. When they evaluate the evidence, first they establish their PICO questions. PICO stands for: what’s the patient? What’s the intervention? What’s the control we’re measuring? What are the outcomes? A lot of outcomes are of interest to influenza. We’re interested in preventing death and hospitalizations. Some outcomes are more critical in nature, and some are important but not as critical. So they tier the outcomes.
From there, they do searches on everything they can find in the literature. Then they develop long lists of data that can be further evaluated. [For example, they might say] “This study is good, but it was small, so there’s a higher risk for bias,” or “This was a randomized controlled trial, top of the line. This was an observational study,” which we’ve seen a lot with some preferentially recommended vaccines. They adjust these data based on their risk for bias. Then they look at the benefits vs harm. They look at the acceptability of their recommendations. They look at equity, whether their proposed recommendation will improve equity or be detrimental to that. Then they generate an overall risk-vs-benefit recommendation. A lot of behind-the-scenes work goes into developing these recommendations. When they come out in 2022 and say that these are preferentially recommended—3 high-dose adjuvant or recombinant [therapies]—in ages 65 and older, a lot of time, effort, and studies behind the scenes helped make that recommendation.
Rodney E. Rohde, PhD, MS, SM (ASCP) CM, SVCM, MBCM, FACSc: This is critical for the general public to hear. I don’t know if we talk about this enough. I do the same thing in laboratory medicine. There’s stuff we know between colleagues. Sometimes this information is helpful to my parents or cousins. [But]…sometimes I worry that expertise is starting to be taken for granted. Expertise matters. You didn’t go to school as long as you did and practice as long as you have to not know what you’re doing. Think about being across the United States or even the world. Individuals behind the scenes are going through the literature of potentially every influenza study in the last year or 2 with respect to vaccination, and then they’re compiling that and making expert recommendations. That may not be perfect for every individual, but we’re trying to parcel that out into the populations we’re talking about.
Randy McDonough, PharmD, MS, BCGP, BCPS, FAPhA: As a practitioner, pointing to those statements is very helpful as you’re educating and working with your patients and showing them that these recommendations are being made. At least they know there’s some authority behind them. This isn’t Randy McDonough giving his opinion. This is something authoritative saying that this is what’s best for you, and these are the reasons why.
Adam C. Welch, PharmD, MBA, FAPhA: The public are often going to get information from the news headline. They’re going to read the title of the article and then make their own conclusions. They’re inferring a lot. They don’t see all the data that have been evaluated and generated to come to the recommendation that we have. Also, [we’re] healthcare providers, so that becomes our role because they trust us and listen to what we say. We’re familiar with all those data that have been generated and evaluated. We can assimilate that into a recommendation to the patients, and they’ll trust us.
Chad Worz, PharmD, BCGP, FASCP: That’s a key point: trust but verify. As a clinician, I don’t know if my understanding of the back-office routine with ACIP was as high as it’s been since COVID-19. We spend a lot of time logging on and saying, “Let’s listen in to this ACIP conversation this time. I want to understand a little more about this.” That translates to the public that there’s got to be this trust but verification that goes on from a clinician standpoint, so they can better communicate to their patients and explain to their patients.
Rodney E. Rohde, PhD, MS, SM (ASCP) CM, SVCM, MBCM, FACSc: The transparency is what we’re talking about.
Randy McDonough, PharmD, MS, BCGP, BCPS, FAPhA: There’s also a lot of bad information, which they’re getting from social media, that’s telling them something else. They need the consistency of a good health care provider giving that information, not just with pharmacists but all the way down the line. We all should have a consistent message.
Adam C. Welch, PharmD, MBA, FAPhA: I can offer 1 piece of advice to community pharmacists, especially those giving influenza vaccines. Every August, ACIP will publish the MMWR [Morbidity and Mortality Weekly Report], which talks about the influenza recommendations for the upcoming flu season. If you want to get up to speed on everything, MMWR is a great resource before you start giving flu shots.
Chad Worz, PharmD, BCGP, FASCP: It’s important. Randy probably can tell stories about this. You hear patients say, “I got the flu shot last year, and I got the flu, so I’m not going to get it again this year.” You have to go through that process of explaining that it’s completely different. Maybe we missed it last year with the wrong strain, or maybe you just happened to get the flu. It’s not 100%. But you have to have that conversation to keep them engaged year after year.
Rodney E. Rohde, PhD, MS, SM (ASCP) CM, SVCM, MBCM, FACSc: You have to have it often.
Chad Worz, PharmD, BCGP, FASCP: Yes.
Randy McDonough, PharmD, MS, BCGP, BCPS, FAPhA: It could have just been the timing. Maybe you were exposed at about the same time you got the flu shot and you weren’t fully protected at that point.
Rodney E. Rohde, PhD, MS, SM (ASCP) CM, SVCM, MBCM, FACSc: To highlight what you had mentioned earlier, Morbidity and Mortality Weekly Report is a publication by CDC [Centers for Disease Control and Prevention]. I look at them constantly in the world of infectious diseases. The public can look at these. They’re very well written. They have expertise, but the general public can consume most of the information. Then you can ask a pharmacist, a physician, a nurse—someone who might help you bridge that gap in terminology or education.
Adam C. Welch, PharmD, MBA, FAPhA: A level 2 pharmacist will have the ACIP email their recommendations. If you get on their mailing list, you’ll be able to get it without having to find it.
Rodney E. Rohde, PhD, MS, SM (ASCP) CM, SVCM, MBCM, FACSc: Great information. These are things that I like to sometimes share with my family. There are other email lists that are based on science and medicine, and hundreds if not thousands of individuals are looking at that data and making these recommendations.
Transcript edited for clarity.