Safeguarding Science: Evidence-Based Vaccine Policy Amid Political Disruption

In the final part of his conversation with Pharmacy Times, immunologist Morgan McSweeney, PhD, addresses the growing tension between scientific evidence and political influence in federal vaccine policy. He outlines why existing advisory structures were never designed to withstand ideologically driven interference, and how pharmacists, immunologists, and public health leaders must work together to preserve evidence-based vaccination practices. McSweeney also breaks down why universal hepatitis B vaccination is necessary in the United States, despite differing approaches in countries with stronger preventive care infrastructure.

Q: As an immunologist, what safeguards should exist to ensure that advisory committees making policy recommendations are guided by robust scientific evidence rather than political or ideological influences?

Morgan McSweeney, PhD: I think this is a big mistake that the field of public health made in the field of science, the field of science broadly in the country, assuming that people would play by the rules of evidence in the field of health, assuming we would never have a Secretary of Health and Human Services who is happy to make up fake citations to support opinions while discounting vast bodies of medical evidence. A lot of the structure of our current medical advisory system in the country is based on the assumption that that wouldn't happen.

Unfortunately, what we've seen is that having one person in charge who doesn't necessarily believe in the correct approach to scientific evidence can dismantle all of that. They can fire an entire vaccine panel, appoint their own members, and basically unilaterally have control over vaccine recommendations for children in the country. In hindsight, probably someone should have thought about this, done some type of war games to say, “What if someone was appointed Secretary of Health and Human Services who wasn’t familiar with the right way to look at scientific evidence? What safeguards should we have in place to stop the carnage that could happen in the health of American children?”

I don’t know exactly what they would have recommended to prevent that from happening, other than some type of system where one person is not capable of unilaterally replacing entire vaccine committees with people who agree with their opinions, and that same person also being in charge of appointing the head of the CDC, who’s the person who has to sign off on the recommendations from that committee. It’s kind of like everything is resting on this one very feeble pin at the bottom, which has been knocked out. And now who knows what’s going to happen with vaccine policy in the country?

Q: In your view, what collaborative roles can pharmacists, immunologists, and public health groups play in ensuring that evidence-based vaccination practices remain intact?

McSweeney: Immunologists, public health experts, pharmacists—I see them as having three separate roles. It’s almost like a relay race. Immunologists up front do the research, analyzing vaccines, outcomes, mechanisms, forming the body of evidence. That is handed off to public health experts, who say, based on this body of evidence, these are the recommendations for American children, the American public, or doctors.

The third handoff is to pharmacists and all healthcare providers who implement those recommendations. Pharmacists close the loop. It doesn’t matter how good the evidence is, or how evidence-based the public health recommendations are, if that never gets communicated to patients, or if it’s not available, or if they’re scared or have seen misinformation and don’t have someone to translate it to them in real-world terms. Pharmacists are that critical end of the loop in getting the body of evidence through to patients in a way that can meaningfully help their health.

Q: Denmark does not recommend universal hepatitis B vaccination, but the United States does. Why is this different?

McSweeney: Denmark doesn’t recommend universal hepatitis B vaccination. The United States does. China does. Many other countries do. A key question that comes up a lot in parents’ minds and even at the vaccine advisory committee is: What’s the basis for that difference? Hepatitis B exists in all of these countries. Why would there be different recommendations for the same vaccine?

The answer comes down to differences in the healthcare systems. There are not differences in hepatitis B in Denmark versus the United States. There are not differences in the vaccine. What’s different is the healthcare systems. In Denmark, far fewer pregnant women fall through the gaps compared to the United States. They have a more robust healthcare system. In the United States, almost a fifth of women never get screened for hepatitis B during pregnancy. In Denmark, it’s much lower. Among children who test positive for hepatitis B, many in the United States don’t get appropriate follow-up care. That’s different in Denmark.

In the United States, we initially tried the exact approach Denmark is using—risk factors and pregnancy test results to identify high-risk infants. Because the U.S. health system is fragmented, particularly in underserved communities, it didn’t work. We had tens of thousands of children still getting infected. So in theory, if you have a very efficient healthcare system, the Denmark approach can work, and they’ve shown that. That’s not what we have in the United States. So to adequately protect children and prevent liver cancer and cirrhosis, we moved to universal vaccination, and that solved the problem.