With decades of experience at the forefront of medical technology and manufacturing, Faisal Zain has a unique perspective on the intersection of public health policy and innovation. He has seen firsthand how regulatory decisions can shape the development and deployment of life-saving diagnostics and treatments. In our conversation, we explored the far-reaching consequences of the ACIP’s recent proposal to roll back the long-standing guidance on the Hepatitis B birth dose vaccine. We discussed the immediate risks to newborns, the potential for a domino effect that could weaken the entire childhood immunization schedule, and the chilling impact such policies could have on the future pipeline for all vaccines.
The National Foundation for Infectious Diseases predicts this new Hepatitis B guidance could cause 1,400 additional infections annually. From a public health standpoint, could you walk me through the step-by-step process by which delaying the birth dose could lead to these severe outcomes for newborns?
It’s a tragic and entirely preventable cascade of events. It starts with the fact that up to half of adults with chronic Hepatitis B don’t even know they’re infected. So, a mother can test negative, but there might be an infected and undiagnosed family member at home. The baby is born, and instead of the automatic protection they’ve received for 30 years, there’s now a moment of hesitation, a complex discussion. The parents, understandably exhausted and overwhelmed, may decide to wait. They take their vulnerable newborn home, where the most common form of transmission occurs—close family contact. That’s all it takes. The baby is exposed, and because their immune system is so immature, they face the highest likelihood of developing a lifelong, chronic infection. This isn’t a mild illness; it’s a direct path to severe complications like cirrhosis and liver cancer, which is why we’re seeing projections of not just 1,400 new infections but also 480 deaths every single year.
The new ACIP guidance recommends “individual-based decision-making” for parents. Given the chaotic nature of childbirth, could you share an example of how this might play out in a hospital setting and what specific challenges parents and providers will face in making this sudden, complex decision?
Imagine you’ve just gone through labor. You’re physically and emotionally drained, you’re trying to learn how to care for this new life, and everything is a blur. In that moment, a healthcare provider has to present you with a complex risk-benefit analysis. They have to ask you to consider infection risks from household members or frequent contacts who may have emigrated from high-prevalence areas. This isn’t a simple choice. It’s an enormous cognitive load placed on parents at their most vulnerable. The most likely outcome, and the one we fear most, is paralysis by analysis. A parent might fully intend to get the vaccine at the two-month check-up, but life with a newborn is chaotic. Appointments get missed, things are forgotten. It’s not neglect; as Dr. Benjamin said, it’s just life. This policy introduces gaps and delays into a system that was designed to be seamless for a reason, leaving the most fragile among us unprotected.
Following changes to MMRV guidance and now Hepatitis B, many experts fear a domino effect. Based on this trend, which other specific childhood vaccines do you believe are most vulnerable to similar rollbacks, and what metrics would you watch to gauge the immediate public health impact?
This decision absolutely won’t be in isolation; the precedent has been set. The most immediate vulnerabilities are for the vaccines that prevent diseases we’re already seeing a resurgence of due to recent declines in vaccination rates. I’m talking specifically about measles and pertussis, or whooping cough. The metrics aren’t theoretical; we’re already watching them climb in real-time. We’ve seen the highest number of measles cases since it was declared eliminated in 2000, and there’s been a staggering six-fold increase in whooping cough this year alone. The most heartbreaking metric, of course, is preventable deaths. We’ve already had children die from both measles and pertussis in 2025—all of them, I believe, were unvaccinated. These aren’t just numbers; they are clear, tragic signals of a public health system beginning to fail. Weakening the guidance on vaccines for these diseases would be like pouring gasoline on a fire that’s already burning.
The new ACIP cited countries like the UK and Denmark as examples for delaying the Hep B birth dose. Could you elaborate on the key differences in their healthcare systems and population demographics that make this a potentially misleading comparison for the United States?
Using countries like Denmark as a model for U.S. policy is fundamentally flawed; it’s not an apples-to-apples comparison. Denmark is a small, relatively homogenous country with a robust, universal healthcare system that can track and follow up with patients seamlessly. The United States is a massive, diverse nation with a fragmented healthcare system. We have significant populations, including non-U.S.-born women who account for nearly 58% of births to mothers who test positive for the Hepatitis B surface antigen, who may face more barriers to consistent healthcare access. A policy that might work in a tightly controlled system like Denmark’s could be disastrous here, where a family might move, lose insurance, or simply fall through the cracks. The universal birth dose was implemented in the U.S. precisely to overcome these systemic challenges and create a simple, effective safety net for every single child, regardless of their family’s circumstances.
Dr. Benjamin voiced concerns for the vaccine pipeline, suggesting manufacturers might be discouraged by policies based on “poor science.” Can you explain the step-by-step process of how shifting public health guidance can impact a company’s financial incentive to invest in developing new or improved vaccines?
From a manufacturing and innovation standpoint, this is my biggest fear. The process is a slow-motion catastrophe for future public health. First, a company invests hundreds of millions, sometimes billions, of dollars and a decade or more of research to create a safe and effective vaccine. It’s an enormous financial gamble. Second, a public health body, using what many experts are calling “poor science,” undermines the universal recommendation for that very product. This instantly creates uncertainty and erodes public and provider confidence. Third, investors, who are crucial for funding this expensive research, see this. They see a safe, life-saving product being sidelined by political shifts, not by scientific data. Their conclusion is simple: why would we invest in the next generation of vaccines if the market can be dismantled overnight by a committee? They will divert their capital to less controversial areas, and the entire pipeline of innovation for new vaccines—for the next pandemic, for new variants, for other diseases—begins to dry up.
What is your forecast for the U.S. childhood immunization schedule and the potential resurgence of vaccine-preventable diseases over the next five years?
My forecast, unfortunately, is quite grim if we continue down this path. I believe the national immunization schedule, which has been a bedrock of public health for decades, will become increasingly fractured. We’ll see a patchwork system where a child’s protection depends more on their zip code or their parents’ ability to navigate a complex web of recommendations than on established science. Consequently, the resurgence of vaccine-preventable diseases is not a potential, but a certainty. We will see more frequent and larger outbreaks of measles, like the one in South Carolina, and more whooping cough. The 99% reduction in childhood Hepatitis B infections we’ve achieved since 1991 will be reversed. We are on the verge of turning back the clock and witnessing a tragic, and entirely preventable, return of childhood death and disability from diseases we had effectively conquered.
