Look to Denmark for guidance on creating vaccine policies, drug research leader says

U.S. health experts and policy makers could look to other nations, such as Denmark, for models of vaccine administration for children, said a physician guiding American drug research.

However, lessons from peer nations might be helpful — or might not be, because the United States is without peer in the world, another health analyst said.

Tracy Beth Hoeg, MD, PhD, this month was appointed acting director of the Center for Drug Evaluation and Research (CDER) under the U.S. Food and Drug Administration (FDA). She participated as an ex-officio member in the Dec. 4 and 5 deliberations of the Advisory Committee on Immunization Practices (ACIP). The panel voted to overturn a decades-old recommendation for universal infant vaccination against hepatitis B.

A dual U.S.-Danish citizen, Hoeg presented data about children’s vaccine recommendations in Denmark, where she lived and earned her doctorate in public health and epidemiology at the University of Copenhagen.

“There are countries that look at the data that we have differently than we do,” she said.

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Danish policy as a model

As of January 2025, the United States had an immunization schedule with 72 total vaccine doses targeting 18 diseases. That is more than Denmark (11 doses targeting 10 diseases), the United Kingdom, (17 doses targeting 12 diseases), Germany (22 doses targeting 15 diseases) and Japan (28 doses targeting 14 diseases).

“It shows how much we really did diverge, at this point, from other developed nations and we also target the most diseases,” Hoeg said. It gets to the question about why the United States is so different, and whether more shots are scientifically and medically justified, she said.

By getting those inoculations, American children are exposed to more aluminum delivered in the shots — 5.9 milligrams by age 2 and 8 milligrams by age 18 — than the youths in the other nations, Hoeg said. There are no robust data to show there are specific health concerns regarding that exposure to aluminum, she said. But there also are no data to show there is an established, safe amount of aluminum that children can received before age 2 or age 18, especially considering the aluminum is not eaten or digested, but delivered to the body in a different way, Hoeg said.

The vaccine experts should admit that science may not know what the side effects may be from the shots, especially when given all at once, Hoeg said.

“And what do we owe our children? We owe our children science-based recommendations here in the United States, and we need to understand the potential for absolute benefit for low-risk populations when we're making a general recommendation for all children, understand the limitations in our knowledge about adverse effects, perform proper, randomized, placebo-controlled trials, continue to monitor safety for safety signals,” Hoeg said.

“Look, you know, we're not going to find things that we're not looking for — that's been mentioned before — and update our recommendations based on evolving knowledge,” Hoeg said. “And have vaccines treated like all other medical products, and admit when they may not be appropriate for all children.”

A matter of trust

Denmark avoids political polarization but maintains a culture of debate, transparent decision-making, and research using randomized controlled trials and extensive documentation about vaccines recommended or not, Hoeg said. That nation also is good at acknowledging unknowns and uncertainties, and promptly reversing recommendations that are not based on evidence or that don’t work, she said.

Her presentation followed ACIP deliberations and a vote to no longer recommend universal infant vaccination against hepatitis B. Denmark and the United States have roughly comparable incidences and prevalences of that disease, but Danish health leaders do not recommend childhood hepatitis B vaccination at all, Hoeg said.

She also discussed other childhood shots and mandates that contribute to a recent loss of trust in medicine because people feel coerced to get shots, particularly with mandates required during the COVID-19 pandemic.

“And I, again, I don't want to say cause and effect, but it's interesting to note the timing of this loss of trust in public health,” Hoeg said.

Comparing apples to oranges?

The same day, in earlier discussion, Hoeg commented about practices of peer nations, and ACIP members also heard about hepatitis B vaccine data from Adam Langer, DVM, MPH, principal deputy director (acting) and associate director for science at the National Center for HIV, Viral Hepatitis, STD, and TB Prevention under the U.S. Centers for Disease Control and Prevention. Langer also commented on policies of peer nations.

“The United States is a unique country. I think that most of us would agree that we don't really have a peer nation in this world. There are other high income nations certainly,” Langer said.

Denmark has a population of 6 million people, while New York city has a population of 8 million people. Denmark screens for hepatitis B in more than 95% of pregnant women, a far higher rate than the United States, Langer said.

Prenatal care is free for citizens and refugee or asylum seekers in Denmark, not the case in the United States. Denmark maintains data on individual health using unique national identification, something the United States does not have and that probably would be impossible under the nation’s culture of privacy, Langer said.

In Denmark, pregnant women who screen positive for hepatitis B are followed up, with additional follow-up, testing and vaccination if needed for infants; in the United States, many infants are lost to follow-up as soon as they leave the hospital, Langer said.

The closest to a peer nation is Canada, where hepatitis B vaccine recommendations are developed at the provincial or territorial level.

“However, recent studies in Canada have shown that universal hepatitis B birth dose is going to be needed to achieve elimination of hep B in Canada, which is exactly what we learned here in the United States decades ago,” Langer said. “They've also done economic studies in Canada and determined that universal hepatitis B birth dose is cost effective. And a number of professional societies, medical societies, have already gone on record as advocating for a national change in policy to adopt universal hepatitis B birth dose. So let's talk about apples to apples, not apples to oranges.”