Vaccine policy meeting: The essentials

Foxes in the hen house and rising above the noise for fall

This week, the Advisory Committee on Immunization Practices (ACIP) held its first public meeting since the new HHS Secretary—an outspoken vaccine skeptic—replaced all 17 members. More than 4,000 people tuned in, a level of attention not seen since the height of the pandemic.

That’s because ACIP decisions have a profound weight in shaping vaccine policy in the U.S. They determine which vaccines are recommended, for whom, if insurers cover them, and when they’re available.

The June meeting is especially important, as it sets the groundwork for the fall respiratory virus season. Insurers finalize coverage. Clinicians place orders. Distributors ship doses. Public health communicators prepare messages. Disrupt this system or timeline, and the entire system falters.

Here are the essential takeaways from the meeting.

Bottom line up front

Flu shots are recommended for everyone over 6 months. However, flu shots containing thimerosal (4–7% of supply) are not, not because of scientific evidence but because of falsehoods.

RSV protection is recommended for pregnant women (vaccine), infants (monoclonal antibody) up to 18 months old, and older adults (vaccine). This fall, a second monoclonal antibody option will be available for parents (which is good) for kids up to 8 months old.

Covid-19 will be available, but for whom, when, and what are still big questions. There was no vote. No guidance today. And there should have been.

Inside the meeting: Foxes in the hen house

This meeting followed the usual format: CDC scientists presented data, and the committee discussed, questioned, and voted on certain policies.

This meeting, undoubtedly, demonstrated the high competence of CDC employees, who were thorough, thoughtful, and well prepared. They answered questions with precision and demonstrated deep expertise. I continue to be incredibly impressed with this group.

For the new committee, it was clear that not all were vaccine experts—they questioned basic epidemiologic methods, misunderstood fundamental scientific principles, and repeated conspiracy theories that have circulated for decades. At times, CDC scientists were educating them on how vaccine trials work, what the immune system does, and how the approval process functions. This is, of course, acceptable for a curious member of the public—it is absolutely unacceptable for people determining vaccine policy for 330 million Americans.

Additionally, many committee members clearly began with conclusions and then attempted to force the evidence to fit. This is called policy-based evidence making (not evidence-based policy making). It’s backwards. There is no new evidence or data to change recommendations. In fact, the committee removed documents that CDC scientists had posted. They stated procedure reasons when asked, but presumably because it did not support their foregone conclusions. This is not demonstrating radical transparency.

And although the committee has disclosed conflicts of interest, as it has for the past 70 years, HHS cannot pretend that pharmaceutical companies are the only conflict of interest. Selling supplements, profiting from medical litigation trials, and holding a leadership position in antivaxxer advocacy groups are all conflicts of interest. None of that was disclosed.

We fact-checked the proceedings in real time and counted (and countered) more than 50 falsehoods. YLE and others compiled three briefings on these falsehoods in near real-time for leaders, communicators, and media. Feel free to download, use, or just view if you have questions about some falsehoods brought up (there were a lot!). Get the briefs here:

https://www.evicollective.org/tec-briefs

Focusing on the science

It’s easy to get caught up in the absurdity, and to be clear, much of it was absurd.

But/and the respiratory virus season is just around the corner, and that matters more as lives are at stake. The CDC’s presentations were strong, and the science behind them was solid. I’m confident that, despite the chaos, the data shared wasn’t influenced by RFK Jr. or this new committee.

So I wanted to walk you through that science—what we know, what protection options will be available this fall, and what questions remain. Because at the end of the day, Americans deserve to be informed and empowered to protect themselves and their communities.

Covid-19 vaccines

COVID-19 remains a serious health threat to Americans and a huge burden on healthcare systems. Last year, hospitalizations for Covid were similar to flu (and the flu season was the worst we’ve seen in past 15 years).

Infants and older adults continue to be most affected. This is why it’s so important for pregnant women to get vaccinated. (Infants cannot get the vaccine until they are at least 6 months old, when maternal antibodies wane and their immune system is more mature.)

Soure: CDC; Annotated by YLE

Last winter’s COVID-19 vaccines provided 30-40% additional protection against urgent care visits, regardless of age, compared to people who did not get the Covid vaccine, and 40-70% additional protection against hospitalizations and ICU stays. Interestingly, protection isn’t waning as quickly nowadays, remaining stable up to the study period (180 days).

Source: CDC; Annotated in red by Your Local Epidemiologist

COVID-19 vaccines also continue to be safe based on the many systems the U.S. federal government has in place.

Myocarditis—inflammation of the heart—is no longer a safety signal like it was for the first two shots of mRNA. Among adolescent boys who did get myocarditis from the first two doses of the vaccine, 91% have fully recovered.

Votes: Usually, the ACIP votes for COVID-19 vaccine eligibility for fall. However, this was taken off the agenda at the last minute for an unknown reason. So, there was no vote. This means we don’t know what the recommendations are for this fall. (See more below in “Next Steps.”)

RSV protection

RSV is among our most burdensome respiratory viruses, particularly for children under 5. So, it was an absolute game-changer when not one, but TWO options of protection became available two years ago for the first time ever:

1. Vaccine for pregnant women (who pass antibodies to their infants) and

2. Monoclonal antibody for infants (not a vaccine, but provides antibodies in the short term)

We’ve already seen a decrease in the burden of RSV in healthcare systems (as shown below).

Source: CDC; Annotated by Your Local Epidemiologist in red.

Presentations showed that both continue to be incredibly effective in the “real world”:

• Maternal vaccination: 70-79% protection against infant hospitalization

• Monoclonal antibody (called nirsevimab): 79-82% effectiveness against infant hospitalization

Both options are also very safe and much better than the disease itself. There is one small but true safety signal scientists are looking closely at: people who get the pregnancy vaccine have a slightly higher rate of gestational hypertension and preeclampsia. This could be due to data or other factors, such as women who are pregnant for the first time. Scientists are still investigating this. However, the benefits of the RSV vaccine still significantly outweigh the risks.

This fall, we will have a THIRD option: A new monoclonal antibody (called clesrovimab) approved by the FDA recently. It works about as effectively as the monoclonal antibody introduced last year. It does wane quicker, so it may not protect as long, but it’s enough for one entire season.

Having another option is good because:

• Lowers cost through competition

• Better access with more choices

• Slightly different virus target, which is good if the virus mutates

The downside is that it’s not for 8-19-month-olds (like the other one), so providers have to stock both, which is a pain.

Votes: The majority of members voted in favor of the monoclonal antibody, meaning it will be available to the public.

Flu vaccines

Last flu season was really bad. The worst in the past 15 years.

And last season, vaccinations continued to prevent a ton of disruption. Last year, it’s estimated the flu vaccine prevented:

• 12,000,000 symptomatic infections

• 240,000 hospitalizations

But the big point of discussion during the ACIP flu section was thimerosal. Lynn Redwood, a former leader of Children’s Health Defense—an antivax advocacy group—presented data. In short, it absolutely flooded the zone with cherry-picked data out of context. It also had fake citations, likely due to the use of AI. External presentations, like this one, typically need to be fact-checked by CDC. Typically, this occurs days or weeks in advance of ACIP meetings. It didn’t happen this time.

There was one sane person on the committee who said, “I don’t know where to start” with all the falsehoods presented. And followed up by saying “there’s no scientific evidence that shows the harm of thimerosal.” I agree.

We debunked many falsehoods in this brief in real time. Here are the facts:

• Thimerosal is an ethylmercury-based preservative that keeps vaccines safe from bacterial contamination.

• It was largely removed in vaccines in United States in 1999 as a precaution, even though no harm was ever demonstrated.

• At the time, there was no specific data on ethylmercury’s toxicity, so safety assessments conservatively applied the limits of methylmercury (the toxic form of mercury found in fish that many of us are familiar with). Using those stricter benchmarks, cumulative exposure from the full childhood schedule slightly exceeded what was considered safe for prenatal methylmercury exposure.

• Since then, numerous studies have demonstrated that ethylmercury is metabolized differently and is safe at the levels used in vaccines.

• In the United States, thimerosal is only found in multidose flu vaccines, and trace amounts are found in TDVax, a tetanus and diphtheria vaccine for people aged seven and older.

• Thimerosal is still used in other parts of the world as a vaccine preservative.

• Thimerosal and the use of multiple vaccines are incredibly important for pandemic preparedness.

Votes: The majority of ACIP members voted to remove flu shots containing thimerosal. This means about 4–7% of the flu vaccine supply won’t be used. This isn’t a huge deal, but it may ripple doubt globally, which would have a significant impact because many global vaccines still contain thimerosal. And the groundwork here is what’s most concerning for future vaccines.

What’s next for fall season

Flu and RSV vaccines will be available for the fall respiratory season. Covid-19 vaccines should be too, but major questions remain unanswered:

• Who will be eligible to receive them?

• Will people have to pay out of pocket, or will insurance and federal programs cover them?

• What are states legally allowed to do if ACIP doesn’t make recommendations?

Manufacturers are making vaccines right now based on last year’s formula (because HHS recently required them to do placebo trials—which is not feasible and unethical—to update it). However, there is considerable confusion around eligibility. I expect we’ll soon see the formation of professional society-led recommendations or even a “shadow ACIP” to fill the vacuum.

It’s time for the broader health ecosystem—payers, providers, health systems, and states—to step up. Americans need a coordinated, unified front to ensure they have clear information, reliable access, and the confidence to make informed decisions to protect their health, their families, and their communities.

On that front, we’re off to a promising start this week:

1. AHIP and the Alliance of Community Health Plans affirmed their commitment to covering fall vaccines, ensuring patients aren’t left with unexpected costs.

2. The American Medical Association and nearly 80 professional organizations issued a strong joint statement: they will continue to follow and promote evidence-based vaccine recommendations, regardless of political interference.

3. Communication experts and trusted messengers are mobilizing to combat confusion, clarify facts, and support local decision-making, especially in the absence of consistent national messaging.

This is progress. However, we need more unified voices and stronger commitments across the system, particularly from governors, employers, pharmacy chains, and community organizations. If we don’t fill the gaps with clarity, falsehoods and confusion will flood in, and vaccine uptake will suffer.

Looking beyond fall: Routine vaccinations at risk

Routine vaccinations, like polio or measles, are still strongly recommended and available. Given this meeting, though, I’m very concerned about their future for three reasons:

1. The ACIP chair announced two new work groups that will look into the cumulative vaccine schedule (examine the total number of recommended vaccines, timing, and the supposed cumulative effects). And they announced they will revisit vaccines that supposedly haven’t been reviewed in over seven years. One target will be the universal implementation of hepatitis B vaccination at birth.

2. Policy-based evidence making: The thimerosal conversation made it clear that this committee had come to a conclusion and then sought evidence to support it.

3. The number of falsehoods flagged was staggering. This suggests that discussions aren’t robust and aren’t anchored in the latest, best evidence.

Bottom line

The science is strong: Vaccines work, save lives, and are very safe. You will have fall vaccines this fall. Covid-19 details are still a big question.

This week’s ACIP meeting made one thing clear: Americans aren’t just fighting viruses this fall, but also confusion and coordinated doubt. Americans deserve a unified health system that steps up with courage to deliver facts, access, and choice, protecting what matters most: lives.

Love, YLE

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Your Local Epidemiologist (YLE) is founded and operated by Dr. Katelyn Jetelina, MPH PhD—an epidemiologist, wife, and mom of two little girls. YLE is a public health newsletter that reaches over 375,000 people in more than 132 countries, with one goal: to translate the ever-evolving public health science so that people are well-equipped to make evidence-based decisions. This newsletter is free to everyone, thanks to the generous support of fellow YLE community members. To support the effort, subscribe or upgrade below: