Executive Vaccine Order: Home run or Own goal?

The US vaccination schedule could be considered to have a reputation as “maximalist”, recommending more vaccines for children than most high income countries. There are occasions I have been critical of it, including its approach to Covid-19 vaccines for children which were so over-zealous that I believe it damaged the credibility of the agencies recommending it.

Perhaps then there is room for improvement? Last week the office of the US President issued an Executive Order regarding the childhood immunisation schedule in the US. I try not to wade into politics, but this Executive Order covers areas of science within my specialty (vaccines) which are worth addressing.

An Executive Order (EO) is simply directions from the White House to existing agencies instructing them how to use powers they already have. It doesn’t do anything itself, but is designed to guide other agencies in how to act.

This EO is aimed at the department of Health and Human Services (HHS) predominantly, with instructions for how to amend the childhood immunisation schedule. There is preamble about how the US offers more vaccines to children than other comparable high income countries and several references throughout the document to, “Gold Standard Science” (it is not clear what this means).

The EO recommends splitting the schedule into three parts:

• Recommended for all children; measles, mumps, rubella, diphtheria, tetanus, pertussis, polio, Hib, pneumococcal disease, HPV and varicella. Eleven diseases, down from the eighteen the CDC recommended in 2024.

• Recommended for high risk groups; RSV monoclonal antibodies, hepatitis A, hepatitis B, meningococcal B, meningococcal ACWY and dengue.

• Shared decision making; hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza and COVID-19.

Then, in a single sentence the EO also recommends that the MMR vaccine be split into its three constituent components and that all childhood vaccines (including components of the MMR) should be offered at separate visits.

There are additional points regarding the way state legislatures handle religious and other exemptions among other things which I won’t go into here.

The EO itself does not accomplish anything and is not legally binding. It is noteworthy that it does not address the federal agencies that are actually responsible for setting the vaccine schedule; the Advisory Committee on Immunization Practices (ACIP) who recommend what the schedule should be, and the CDC who signs it off. This signature triggers Vaccines for Children eligibility and no-cost-sharing under the Affordable Care Act which is how children actually access the vaccines.

The US vaccine schedule has elements to it I don’t believe are high value, such as recommending annual Covid-19 vaccination to all children aged 6 months and older (now under shared decision making). The UK doesn’t offer it at all to otherwise healthy children, and has never offered it to children <5y (which is true for many high income countries). Recommending three doses of a vaccine to a 2 year old for a virus that people can see is no different to other routine respiratory viruses for them was never going to land well. The poor uptake was predictable.

I also believe vaccine mandates are ultimately a bad idea. They increase uptake in the short term at the cost of decreasing trust overall. That said, once they are in place, repealing them is dangerous as it is likely to imply lack of confidence in vaccination and lower uptake further.

Whilst it is good to consider how the US vaccine program could be improved, this EO does not help and in fact has several catastrophic blunders in it.

Until the advent of the highly effective and safe conjugate vaccines, Meningococcus was a scourge of children’s hospitals. It is a devastating illness which can cause rapid onset sepsis and/or meningitis, resulting in death, disability or loss of limbs. It still occurs, but is now so rare that new resident doctors never have seen a case.

The MenACWY vaccines are particularly excellent, because they are sterilising. They prevent you from carrying the bacteria harmlessly in your throat, thereby preventing it being passed to others. You can essentially get rid of the bacteria from circulation by vaccinating groups who are known to carry it most; teenagers. Failing to vaccinate a high enough proportion of teenagers to Meningococcal serogroups A,C, W and Y would almost certainly lead to an increase in circulation and more death and disability of infants and young adults. The HHS assessment briefing document which compares the US vaccination program to other “comparable” nations showed that 15 of the 20 other nations already recommend meningococcal vaccination to all children.

For a vaccine with one of the best safety and reactogenicity profiles, moving it from recommended to shared decision making is a needless risk to take.

But it gets worse.

For an EO with a large focus on the number of vaccine doses US children receive, it seems unfathomable that they would make a recommendation to needlessly increase the number of doses children would receive by splitting MMR into three separate injections.

No justification is given in the EO for the recommendation to split MMR (other than it is based on “Gold Standard Science”), but the signing ceremony for the EO addressed the issue by referencing “Autism in particular”. This is absurd. Far from being based on science, this runs counter to all of the research conducted to investigate this issue since the completely fraudulent publication by struck-off physician Andrew Wakefield.

I want to be completely clear on this: No research has ever demonstrated a causal link between the MMR vaccine and autism, and certainly no research has ever suggested that splitting this into three separate components would be any different. To the contrary, abundant high quality evidence has consistently failed to show any causal link between the MMR vaccine and autism. The point was originally raised by Wakefield who had himself patented a single dose measles vaccine and stood to profit enormously from his own falsified claims.

For further background on measles and its vaccine you can read here.

Worse, as one would expect, we know that splitting this vaccine into separate components reduces uptake. Trying to suggest such a thing at a time when the US is battling frequent measles outbreaks and is almost certain to lose its measles elimination status this year is disastrous.

In a welcome response to this bewildering recommendation, neither of the two manufacturers of the MMR vaccine (Merck and GSK) has indicated any intention of manufacturing split component vaccines, due to the evidence of the safety and efficacy of current products and known harms of splitting it into several different shots. Hopefully this will simply become impossible to push any further because the product will not exist.

Not only are extra injections being recommended by splitting the MMR into three components, but in the same sentence, they recommend all vaccines are administered at separate healthcare visits. This would mean for infants in the US who would currently receive their infant vaccines in 3 different visits at age 2, 4 and 6 months, they would need to attend up to sixteen different healthcare appointments to receive the same number of vaccinations.

Once more, no justification is provided in the text. We again only have comments made during the signing ceremony, referencing the volume of vaccine being administered to children as comparable to a bottle of soda (simple maths tells us the maximum cumulative volume administered to a child up to the age of 18 who received all recommended vaccines to be ~30mL). The implications of this, or why it would be preferred to administer the trivial amounts of fluid received via the vaccines (~0.5mL per injection) over separate visits is unclear. This recommendation is unfeasible in practice and would result in significantly reduced vaccine uptake as even the most willing families would struggle to attend so many appointments.

The premise of the EO is misguided. Comparing geographically small and homogenous countries like the UK, Sweden or Denmark to a country the size of a continent with a diverse array of communicable disease threats doesn’t make sense. What makes more sense is to approach each individual vaccine recommendation and evaluate it on its own merit. I will not do that here as that is a task worthy of a dedicated task force (hence countries providing their own task force such as ACIP or the JCVI).

For now, let us take the high income country the US is most comparable to - the UK. There are few differences in diseases covered by the US and UK. These include Hepatitis A, of which the UK has close to zero locally acquired cases and the US used to experience frequent outbreaks until routine immunisation. Or dengue, which occurs in particular regions of the US and is not endemic anywhere in the UK. Or the BCG, which the UK does offer for high risk populations and the US doesn’t at all.

In fact, to become more US-like (in a positive way) UK is adding more diseases to its schedule. We have just added another component to the MMR (Varicella into the now MMRV). We are also adding in an adolescent MenB vaccine (and already offer an infant MenB dose beyond the US).

The big differences are that the UK delivers several multi-component vaccines such as the 6-in-1 infant vaccine (Hib, DTaP, Polio, HepB), and has reduced the number of doses administered of some vaccines such as the HPV vaccine (down from 3 to 1) and the Pneumococcal vaccine (down from 3 to 2). Remember this point.

It is worth noting despite this, that in the document the HHS uses as its assessment underlying the comparison to other countries, the new recommendation wouldn’t bring the US in line with other countries; it would drop it to among the lowest of any comparable nation despite it being so huge and geographically diverse, and having health systems in no way comparable to e.g., Denmark, which would be the only country recommending fewer vaccinations. Based on the EO, the US would recommend vaccinations against fewer diseases than Guinea-Bissau.

Incredibly, the HHS review document actually recommends giving more multivalent vaccines to reduce the number of injections required - the opposite of what the EO is now suggesting for MMR.

This EO which wishes to reduce the number of injections children in the US receive seems set to only increase the required number of injections and increase the total volume of vaccine administered. It is a document which defeats its own stated goals through its own recommendations, and in spite of a briefing document which recommends precisely the opposite approach.

If the aim is to consolidate what could be seen as an unwieldy schedule, this could be considered laudable. If you try to pack too much in, you risk reducing uptake which is the cornerstone of successful vaccine policy (especially where herd immunity is at play). Following the UK in simplifying the schedule for certain diseases by reducing the number of doses, and increasing the number of multivalent injections would be the perfect solution and would reduce the number of injections by more than thirty1. I would recommend it. The HHS reference document even hints at it. Instead, the EO has recommended the opposite.

Based on the considerable existing evidence around these vaccines and their implementation, the most likely outcome of these recommendations being implemented would be to reduce vaccine coverage among the population and a resulting increase in vaccine preventable disease.

The only justification given for splitting MMR flies directly in the face of the extensive scientific evidence which shows no link to autism, and instead leans on unethical, fraudulent research which was exposed over 20 years ago.

Given the previous mess that the HHS made of ACIP and the extensive legal entanglements which continue in the wake of this, the lack of any split MMR products to even administer, and the extensive pushback the EO has already received from other lawmakers in the US, it’s not clear what will practically change in the US as a result.

What will likely continue to change is the erosion of trust in vaccines and the vaccine schedule in a country which is already seeing the consequences of playing political games with the health of children. They continue to be the ones set to lose.

The White House has clearly been grossly misled about the state of the scientific evidence on these basic vaccination safety and efficacy issues. The people providing this false and misleading information are doing a disservice to the children of the US, and these actions are an embarrassment to the governing administration. It is not too late to change course.