Who should serve on the vaccine advisory committee (ACIP)?

If you're designing a vaccine trial for Pfizer, should you vote on Merck?

This week the CDC did something unprecedented. It made easily available the conflicts of interest for the panelists on the ACIP— that's the committee that decides what vaccines to recommend to American adults and children. The new web-tool is quick, easy and revealing.

Make no mistake: the ACIP has made tremendous errors.

1. They recommended that the covid-19 booster be added to the children's immunization schedule. Not only is there no randomized data on meaningful endpoints to support that claim, there is no data at all to support that claim— because the claim applies to novel products that have not even been made. The ACIP knows that a baby born in 2027 will need a covid shot only made in 2027* at 6 months of age. That’s fortune-telling, not science.

2. The committee made no substantive effort to mitigate the risk of myocarditis in young men. It didn’t delay doses or space them out promptly. It did not advise against Moderna.

3. The committee made no effort to reduce the burden of vaccination among people who had already had covid. They gave no credit for natural immunity.

4. The committee repeatedly sought a one-size-fits-all policy even though all scientific evidence suggested an age gradient of benefit and risk.

5. The committee repeatedly declined to follow the lead of multiple European nations that were more sensible and focus on the elderly.

Now we can easily look up the financial conflicts and members of the committee. Let me show you a few examples:

In some cases, these members recused themselves or did not participate in votes for trials that they helped run, or for companies that they immediately had a financial relationship, but many of them did shape the discussion and vote on other, related vaccine products and related spaces.

Let me give you a thought experiment:

Imagine one company makes a maternal RSV vaccine. The vaccine lowers lower respiratory tract hospitalizations (LRTH) from RSV, but the trial fails to find an improvement in all-cause lower respiratory tract hospitalizations. The vaccine is also linked to a non-statistically significant increase in low birth weight babies, as is a competing product, raising question of a class effect.

How do you vote? Should we recommend it? Or should we note that the reduction in RSV LRTH didn’t translate to all-cause LRTH, and certainly not all cause hospitalizations and death? Do we worry about the safety?

How you vote might be different if parallel to the meeting you are meeting with 3 other companies with similar products who want you to run their trial. If you vote for a low bar now, it will make it easy for a low bar in the future. You might recuse yourself from the current vote, but your actions paved the regulatory trajectory for the space.

Of course, this is the reality. And it applies more broadly. The more you vote to recommend products under considerable uncertainty, the more you benefit the companies. The more revenue the companies have, the more they invest back in you. The more vaccine trials you conduct— the more QI projects you run for Pfizer or Sanofi, the more consulting you do years later for Merck.

The people who shape the standards of evidence for vaccine safety and efficacy are those whose entire careers benefit from lower standards of approval. That means more products— even if some of those are eventually withdrawn (e.g. J&J covid).

If I make donuts, a high regulatory bar for cupcakes is bad for me too. Maybe it is best to get people who don’t run bakeries to vote on cupcake policy.

Now, you might argue: this is the case on all drug advisory committees. Exactly! It is a problem everywhere, but surely you must concede that optics matter the most for vaccines!

We have to accept there is a growing faction of people skeptical of vaccines. These people are extremely concerned that the profit motive is taking precedence over an impartial and sober examination of the evidence. These people will be less likely to accept your recommendations if they view it as compromised. So why continue to tolerate these conflicts?

Some argue that there is no one who can serve on these committees who isn’t conflicted. Every single person smart enough to advise on vaccines works with companies. This just isn’t true. Will Ward is an internist who writes in these pages. He is a recent residency graduate. He is a student of EBM. If I give Will 2 weeks to research a vaccine, I would personally trust his recommendation more than any vaccinologist— because he knows how to review data.

The same is true for dozens of others students of evidence based medicine. Yes, of course, you need to learn the basics of RSV and LRTH, but the key questions about risk and benefit can be adjudicated by any careful student of EBM.

And guess what: most of these people— thoughtful doctors, methodologists, economists, statisticians— do not have conflicts in this space.

Many have expressed concern that Mr. Kennedy will seek to modify the ACIP. It would be unimaginable for him not to. The current status quo allows too many people who benefit from low regulatory standards to shape this discussion. The status quo has made too many mistakes. A cornerstone of public health is that our processes should be acceptable to the American people, but that is not the case. There is a concerning decline in childhood immunization across the board. Perhaps Americans need to heard the message of what vaccines are safe and effective from someone who isn’t stuffing their pockets with Merck money. The status quo— ignoring these conflicts and public perception— will only lead to more measles outbreaks— a great tragedy. Instead, rebuilding ACIP with thoughtful, non-conflicted experts is best.

And finally, how smart as these vaccine experts anyway? Toddlers in day care… that was embarrassing and wrong.

*against a strain that Peter Marks decides on while on the toilet at 3 AM