Four measles deaths, a looming policy comment deadline, and how to read a study: The State of US Vaccine Policy

Welcome to our biweekly series in partnership with CIDRAP at the University of Minnesota. 

Every two weeks, we walk through what changed in vaccine policy and what it means for your family. We’re going to keep doing that, with a few tweaks.

Think about biting into a jelly donut. The jelly shoots out the side, lands on your face and on your light-colored pants (because of course it does…), and for the next ten minutes, it’s the only thing you can think about. 

Vaccine policy news is the jelly. It’s bold and messy, it feels existential, and it takes center stage every time. Most of what you’re actually eating, though, is the dough. For most of us, the dough is what shows up in our feeds every day, like the study a cousin shared or the screenshot of a chart with a scary and misleading caption. 

Some of the people sharing these are earnestly trying to make sense of them, while others are stripping out the context on purpose. It adds up to the bulk of what people consume about vaccines, and it’s what you ask us about most. (The most common message in our inbox is some version of, “Can you look at this study?”)

So, we’re adjusting the format of this series a smidge. The policy section will be shorter and more practical, with less time in the procedural weeds. Each edition will also include a new section in which we take a vaccine-related study that’s circulating widely and walk through the findings and whether the corresponding claims about it actually hold up. We’ll cover strong studies as well as weak ones.

Before we break down our first study, we want to share how we read one. So, how do you approach a paper when you don’t have a PhD and you have about ten minutes? Let’s discuss…

The PDF version of today’s update is here. Read past installments here and today’s update on the Unbiased Science Substack here.

The State of U.S. Vaccine Policy, in Brief

The recommendations didn’t change in the past two weeks, but access did for some families, and several things happened that could reshape recommendations in the coming months, including one with a deadline this Sunday.

1. You have until Sunday to weigh in on which vaccines stay “routine”

Federal vaccine recommendations fall into three categories, which are routine (recommended for everyone in an age-group), risk-based, and shared clinical decision-making (a case-by-case conversation with a clinician). The Department of Health and Human Services (HHS) is asking the public whether to change those categories. 

A request like this doesn’t change policy, but the comments become the official record for whatever HHS does next, and a one-sided record makes big changes easier to defend. Insurance coverage, electronic health record reminders, school-entry rules, and pharmacist standing orders all depend on a vaccine being labeled routine, so moving a vaccine out of that category can mean extra appointments, confusion at the pharmacy counter, and eventually out-of-pocket costs. 

The comment window was 30 days (60 to 90 is typical) and closes Sunday, September 20. Our colleagues at The Evidence Collective wrote a guide covering what to say and how to submit. And Dr. Jake Scott wrote a more in-depth CIDRAP Op-Ed about why it matters. Submitting comments takes only about ten minutes.

2. Updated COVID vaccines aren’t yet available to about half of U.S. kids

The U.S. Food and Drug Administration (FDA) approved this season’s COVID vaccines nearly three weeks ago, and kids with private insurance can get them now. The Vaccines for Children (VFC) program—which provides free vaccines to children who are uninsured, underinsured, Medicaid-eligible, or American Indian or Alaska Native—covers about half of the country’s children, and states can’t order doses for it until HHS signs off. As of yesterday, HHS had not decided whether to offer the shots through the program. (The same holdup affects the program for uninsured adults.) 

Pfizer and Moderna both say doses have shipped and there’s no shortage. Part of the problem is that the Advisory Committee on Immunization Practices (ACIP), the expert committee that advises the Centers for Disease Control and Prevention (CDC) on vaccines, normally votes on what the VFC program covers, and the committee is in legal limbo (see item 4). The medical societies recommend COVID vaccination for all children 6 to 23 months old and for older kids with underlying conditions. Older children can still receive the COVID vaccine based on parental choice. 

If your child gets vaccines through this program, ask your pediatrician or local health department to let you know when doses arrive. For everyone else, call ahead, since not every pediatric office stocks COVID vaccines, and pharmacists in some states can’t vaccinate young children.

3. Pennsylvania has confirmed 4 measles deaths, and senators raised it at yesterday’s hearing

Pennsylvania health officials have confirmed four measles-related deaths this year, which is the most the U.S. has recorded in a single year since 1992. The two most recent involved adults aged 18 and 40, both unvaccinated (the first two were infants). As of yesterday, the state had reported 731 cases across 38 counties, with 141 people hospitalized, and nearly all cases were in people who were unvaccinated. At yesterday’s Senate hearing, Sen. Bill Cassidy (the Republican physician who chairs the health committee) tied the deaths to misinformation and federal policy, and pressed the surgeon general nominee, Dr. Nicole Saphier, to say plainly that vaccines don’t cause autism. 

After first answering that she hadn’t seen reputable evidence of a link, she said, “I do not believe childhood vaccines cause autism.” She praised the hepatitis B birth dose but stopped short of saying it should be recommended. If you aren’t sure whether you or your kids are up to date on the measles, mumps, and rubella (MMR) vaccine, check with your clinician, since two doses are about 97% effective against measles.

4. An appeals court will hear the fight over the childhood vaccine schedule on October 6

If you’ve been with us for a while, you know that there is a long legal process playing out in the background. After HHS cut the number of routinely recommended childhood vaccines in January, the American Academy of Pediatrics (AAP) and other medical groups sued. A federal judge blocked the schedule changes and new ACIP appointments in March, but that order was preliminary, and the government appealed. The appeals court could uphold, narrow, or reverse it, and oral arguments are set for October 6.

A separate lawsuit (brought by attorneys general from 14 states and the governor of Pennsylvania) produced a ruling that the government is expected to cite in its appeal, because the judge found that the states can’t challenge who sits on the ACIP. The states can continue to challenge the schedule changes, since they have plausibly shown that demoting vaccines to shared clinical decision-making costs them money and administrative time, and harms public health. 

5. NIH is opening a research center to study vaccine injuries

Science reported that the National Institutes of Health (NIH) plans to open a clinical research center, possibly in mid-October, to study people who’ve developed long-term symptoms after vaccination, with a heavy focus on COVID vaccines. Rare adverse events happen, and the people experiencing them deserve rigorous research (several vaccine scientists quoted in the piece welcomed the idea). Whether the center helps them depends on how well the work is done, and NIH’s own planning documents acknowledge the challenges, which include inconsistent case definitions, symptoms that overlap with long COVID, and very few vaccinated people who were never infected to serve as a comparison group. We’ll cover the findings in our new study section when they’re published.

6. So, whose recommendations should your family follow right now?

With the federal process tied up in court, we’re following the professional medical societies. For flu, COVID, and respiratory syncytial virus (RSV), the American Medical Association (AMA) has gathered this season’s recommendations from the AAP, American Academy of Family Physicians (AAFP), American College of Obstetricians and Gynecologists (ACOG), and the Infectious Diseases Society of America (IDSA) in one place, all informed by an independent evidence review from CIDRAP’s Vaccine Integrity Project. For childhood vaccines, the AAP schedule is the one to use. Insurers have said they will cover this season’s shots (confirm with your plan before your appointment), so don’t wait for a court ruling to schedule them.

Study Breakdown: A Walk Through the House

Scientific papers can look like a wall of jargon, but nearly all of them are built the same way. We’ve compared a paper to a house before, because every section has a job the way every room does. Once you know the layout, you can walk into any paper and know where to find what you need. (For the full tour, we have a longer primer on the anatomy of a paper.) What follows is the walkthrough we do ourselves when a vaccine study lands in our inbox.

Some people argue that anyone without research training shouldn’t be reading scientific papers at all. We understand the concern, since methods take years to learn and a little knowledge can create a lot of misplaced confidence. Realistically, though, people are engaging with research every day whether they’ve been trained or not, because it’s landing in their feeds. The least we can do is help them understand what they’re looking at, and make it harder for someone to manipulate them with a cropped chart.

1. Make sure there’s a house. The chart your cousin shared is a photo of a house listing. We’ve all seen the listing where the kitchen looks spacious, and then you show up and it’s the size of a shoebox. A cropped chart with a caption works the same way, so you need to see the place in person. Find the paper itself and check what kind of document it is. A peer-reviewed article, a preprint (which hasn’t been reviewed yet), a conference abstract, and an upload to an open repository (where anyone can post anything) have each had a different amount of vetting, which is useful to know before you step inside.

2. The front door (title and authors). Titles can be misleading, so use them as a starting point. Look at who wrote the paper and where they work, and whether their training matches the topic.

3. The front porch and foyer (plain language summary and abstract). If the journal offers a plain language summary, start there. The abstract is an approximately 250-word overview written by the authors, and it’s good for deciding whether to keep reading. Most viral posts never get past it (many never get past the title).

4. The foundation (introduction). This is where the authors explain why they did the study and what question they set out to answer. Pin that question down before you look at any results, because viral posts often claim a study answered a different question than the one it asked.

5. The blueprint (methods). This is where a lot of people get overwhelmed, usually right around the statistics. You don’t need to be a statistician to get through it (you also don’t need to be an architect to look at a floor plan and find the kitchen). The type of data the researchers collected and the question they asked dictate which analysis is appropriate, so when you hit an unfamiliar test name, read it as the authors telling you what they did to the data to answer their question. For vaccine studies, skim for who was studied, what the comparison group was, and what outcome was measured. People who get vaccinated tend to differ from people who don’t in age, underlying health, and how often they see a doctor, and those differences can create or hide an effect. A well-designed study explains how it accounted for them.

6. The living room (results). “Doubles the risk” can mean going from 1 in a million to 2 in a million. Look for absolute numbers alongside relative ones, then check the sample size and the confidence intervals (a wide interval means a lot of uncertainty around the estimate). “Statistically significant” tells you a result is unlikely to occur by chance alone, which is different from the effect being large enough to matter.

7. The library and the mud room (discussion and conclusion). Authors usually list what their study couldn’t address, and their conclusions tend to be more cautious than the caption that sent you there. A lot of the distortion we see happens after publication, when a careful “associated with” turns into “causes” on social media. (If you haven’t seen the Spurious Correlations page yet, you’re in for a real treat!)

8. The inspection report (funding, competing interests, data availability). Industry funding isn’t automatically disqualifying, and it isn’t the only kind of conflict. Authors who serve as paid expert witnesses or sell products tied to their conclusions have a stake, too. Publicly available data is a good sign, since it means others can check the work.

9. The neighborhood (the rest of the evidence). One study rarely overturns a body of evidence, in either direction. There is also no single best study design. Randomized trials are powerful, but we can’t ethically withhold an effective vaccine to run one, and rare outcomes only show up in the millions of people that observational data can provide. We ask whether the design fits the question and whether the conclusions are supported by the data.

Learning to read studies helps you ask better questions and make sense of health news. It works best alongside expert interpretation and scientific consensus, since a single paper read in isolation can mislead even people who do this for a living. Starting next edition, we’ll put this walkthrough to work on a study of interest, so please email your requests to vaccines@unbiasedscience.com.

Stay Curious,

Unbiased Science