Vaccine Recommendations Are Changing. What Might Happen Next?

In early June, JAMA published an article on vaccination rates for measles (MMR) in the U.S. since 2017. They have declined to just over 91%. This comes at the same time as a spike in measles outbreaks across the country. We are also seeing significant changes in who makes decisions about vaccines in the U.S. Robert F. Kennedy Jr. is heading up Health and Human Services, and he has made no secret of his distrust of the current approach to vaccines.

What started as an active debate about vaccine safety during childhood and pregnancy has led to possible changes in the availability of vaccines for those who want them. This is not only bad from a public health perspective but incredibly confusing for pregnant people and parents of young kids who are navigating these decisions.

So, how panicked should you be about changes to vaccine access? I do not have a crystal ball on this one, but I can offer context for what might happen and a simple call to action if you’re looking for something to do. 

Background: FDA and ACIP

There are at least two important players in vaccines in the U.S. The first is the FDA, which is responsible for approving vaccines. When a drug manufacturer develops a new vaccine, it undergoes a series of (placebo-controlled) trials supervised by the FDA before being evaluated for approval. 

The Advisory Committee on Immunization Practices (ACIP, pronounced ay-sip) is inside the CDC. This group is responsible for making recommendations about who should receive vaccines. Most notably, this is the group that develops the recommended pediatric vaccine schedule. During the pandemic, this group had an important role in making recommendations about who should receive the COVID-19 vaccine.  

ACIP follows the FDA; they do not approve (or disapprove) vaccines on their own. If this committee, for example, removed a vaccine from the childhood vaccination schedule, that would not mean that children immediately could not get the vaccine. However, they play an important role in what is recommended by pediatricians and what is covered by insurance, including public insurance like Medicaid. Removing something from the recommended pediatric vaccine schedule could mean that some insurers or public providers of vaccines might not offer it, making access challenging down the line. 

What has changed recently?

There have been two significant changes since the new administration arrived.

The first is a change, on the side of the FDA, to how COVID boosters will be evaluated. Because COVID-19 boosters are new every year, they must go through FDA approval. In public statements, including an editorial in NEJM, FDA officials have indicated they plan to change the approach to the approval of COVID-19 booster shots. 

In particular, up until now, COVID-19 booster shots have been treated like the yearly flu shot. This has meant that in order to approve them, the FDA has required safety evidence and evidence that they produce antibodies against the circulating strain of the virus. Going forward, the FDA has said it will use this standard to approve COVID-19 booster shots for people over 65 and for individuals under 65 with at least one condition that puts them at risk for severe COVID-19. However, the younger and healthy population will require controlled trials before approvals are issued. 

This change from the FDA is only about COVID-19 vaccines. 

The second change is that RFK Jr., in his role as Secretary of Health and Human Services, removed all 17 existing members of ACIP and has begun to replace them with a slate of people who are (on average) more skeptical of vaccination. 

This group met for the first time last week and, perhaps not surprisingly, indicated an openness to vaccine skepticism. The meeting opened with a promise to review the childhood vaccine schedule and included a presentation from a noted vaccine skeptic on flu vaccines. 

What will happen to vaccines?

Let’s start by saying this is hard to predict. Two years ago, I’m not sure anyone had “maybe we won’t have the measles vaccines” on their bingo card. But I think we can make some speculative guesses based on what we have seen so far. 

COVID vaccines

I expect access to COVID vaccines to be significantly curtailed going forward. If you are an adult without chronic medical conditions or you’re looking for a COVID booster for your healthy child, I believe this will not be easily available, if at all.

There are a few reasons for this. First, the messaging from the FDA discussed above means that booster vaccines are likely not to even be approved for people under 65 without other conditions. The type of placebo-controlled trials they say they will require will not happen — they would take too long and be too expensive for a vaccine that is new every year. 

Second, there is not likely to be very much public pressure for booster doses since the take-up in the last couple of years has been very low. The illness risk from COVID for most healthy adults and children is fairly small, which has made these vaccines less of a priority. Removing access to them is not likely to bring a lot of objections. 

Third, a number of the people who have been put on ACIP (especially Robert Malone and Martin Kilduff) have been very publicly opposed to COVID vaccines in particular.

Putting all this together, it seems very likely COVID vaccines will become less common. Booster doses for older adults are likely to remain, given their high risk for serious illness and death. Initial doses for children feel like the place with the most uncertainty — there will be voices pushing to avoid these altogether, but because more children get initial doses than boosters, companies have more reason to invest in further trials.

Flu vaccines

Flu vaccines are likely to continue to be recommended. In their NEJM editorial on COVID, FDA leadership drew a distinction with the flu vaccine, implicitly suggesting they are not planning to treat that vaccine in the same manner as the COVID vaccine. There is good data showing that flu vaccines for children prevent illness and death in older adults, in addition to protecting children themselves. 

In their meeting last week, ACIP heard a presentation on thimerosal, a preservative used in multi-dose flu vaccine vials to prevent contamination. They voted to recommend that this not be used. To be clear: there is no reliable evidence ot suggest dangers from this, but it has long been a target for vaccine skeptics. 

Obviously, there are concerns about this rhetoric and the lack of good evidence for this decision. But from a practical standpoint, this is not likely to impact flu vaccine availability very much—most flu vaccines are given in single-dose vials, which do not rely on this, and there are other preservative options. At the meeting, ACIP also recommended the flu vaccine for all Americans over 6 months.

Childhood vaccine schedule

The most fraught and uncertain part of this is the possibility of changes to the childhood vaccine schedule. The current schedule includes vaccines that protect against a large number of illnesses — some you’re more familiar with, like measles and whooping cough, but also rotavirus, pneumococcal disease, and others.

First, there is no current suggestion of removing approvals for existing vaccines. There are limited mechanisms and probably no public support for, say, removing the approvals of the MMR vaccine or others.

What ACIP can do is change the recommendations for the child vaccine schedule in several ways.

• Removing vaccines from the schedule. This would be the most extreme change. It would not preclude people from getting the vaccines, but it could change what is reimbursed by insurance or offered in public vaccine programs like Medicaid (which covers a lot of vaccinations for lower-income children). 
• Leaving vaccines on the schedule but indicating they should be discussed individually with doctors. This is the change that was already made for COVID-19 vaccines for children. It would likely mean they are still covered by insurance and public programs, but it would be more difficult for schools to require them for enrollment. The change in messaging will also likely lower take-up.
• Leaving vaccines on the schedule but modifying the timing, perhaps delaying or adding more time between vaccines. There is no evidence-based reason to do this, but spaced-out vaccines are likely better than no vaccines. 

In my view, the second option is the most likely. This reason is that it satisfies the people who want vaccines to be a personal choice while limiting some of the maximal protests. It will lower vaccination rates, but the messaging seems like it’s just increasing personal choice. I believe the changes will start with the hepatitis B vaccine at birth, which has long been a talking point for vaccine skeptics, and which was mentioned at last week’s ACIP meeting.   

Any move like this will also continue to erode trust in vaccines and, as a result, decrease vaccine rates. New data shows declines in MMR vaccination rates in the last eight years; they are now around 91% in the U.S. on average (down from close to 94%) and much lower in some areas than others. This decline seems likely to continue no matter what, and changes to the vaccine schedule will accelerate it. 

Closing thoughts 

If I sound worried, it’s because I am worried about erosion in trust in childhood vaccines and lower rates of childhood vaccination. If vaccine rates drop significantly, children will die of vaccine-preventable diseases. I believe this to be true based on science and extensive historical and current evidence. I am aware that vaccines, like all medical treatments, carry small risks. But the benefits so far outweigh these that it is frustrating and upsetting to think that children may die for no reason.

I am especially concerned that these changes will disproportionately impact families with fewer resources, especially if these changes hit free vaccine programs. For families with more flexibility or means, routine vaccinations will still likely be available as many doctors will continue to offer them. In fact, if measles cases rise significantly, we’re likely to see vaccine availability at younger ages for kids who want it. But where this will hit more is for families with less medical access, less money to pay for vaccines if insurance does not cover them, and less ability to get good information about benefits and risks. 

The best thing to do is call your senator or congressperson, especially if you live in a red state. There are moves that Congress can make to limit these actions, but they need to hear from constituents that this matters to them. 

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