Former FDA Chief Scientist Jesse Goodman Breaks Down the Implications of Pediatric Vaccine Guideline Changes

In an email interview with Pharmacy Times, Jesse Goodman, MD, MPH, former chief scientist of the FDA and current director of COMPASS at Georgetown University, offers a clear, levelheaded look at what the recent scaling back of recommended pediatric vaccines could mean for patients, providers, and the broader public health landscape. Drawing on decades of regulatory, scientific, and public health experience, Goodman discusses the rationale behind these changes, potential risks and benefits, and how pharmacists and other frontline clinicians can help families navigate evolving guidance with confidence and clarity.

Q: Given your experience as the FDA’s former Chief Scientist, how do you interpret the scientific and regulatory factors driving recent decisions to scale back certain recommended pediatric vaccines?

Jesse Goodman, MD, MPH: There is no new scientific or regulatory information. This seems to be an entirely arbitrary decision taken by appointees who generally cast doubt on vaccines and have done so totally bypassing normal review and public input processes. These vaccines were all previously strongly recommended by the Advisory Committee on Immunization Practices (ACIP) and CDC and fully evaluated by the FDA because they all have proven benefits in protecting children that far outweigh any risks.

Q: From a public health standpoint, what do you see as the most significant long-term risks of reduced vaccine uptake or narrower vaccine recommendations for children?

Goodman: The withdrawal of clear recommendations for these vaccines will sow confusion and raise doubts about their value and about whether people can access them. As a result, fewer children will be vaccinated with these vaccines and, potentially, others. There will ultimately be more disease and more outbreaks. Schools and communities will be less healthy places.

Each of these infections has serious consequences that vaccines help prevent. For example, before vaccines were available, 50,000 to 70,000 kids were hospitalized each year with dehydration from rotavirus. Now, that almost never happens (although it does in Denmark, which, unlike most well-off nations, does not recommend the rotavirus vaccine).

Although hepatitis A is usually self-limited, it makes many people very sick. No one would want their child or relative to have acute hepatitis A. Hepatitis B often chronically infects young children and can lead to liver failure and cancer later in life. Meningococcal meningitis is fatal despite antibiotics in approximately 15%, and at least that proportion of survivors are left with long-term disabilities ranging from neurologic impairment to lost limbs.

Influenza killed almost 300 children last year. Do we really want to go back to these diseases becoming more common and more of a risk to our children, including in school?

Q: How might these changes influence national preparedness for future outbreaks, especially for diseases that were previously well-controlled through robust childhood vaccination programs?

Goodman: We are already seeing ongoing outbreaks of measles and whooping cough and, of course, influenza. Casting doubt on and undermining trust in vaccines risks further undermining US preparedness and response capabilities. Reducing predictability of vaccine recommendations and use will disincentivize manufacturers from investing in vaccine innovation and maintaining the infrastructure needed to keep vaccines safe and available and to respond to future emergencies.

Q: What role should federal agencies such as the FDA, CDC, and National Institutes of Health play in communicating the rationale behind scaled-back recommendations to avoid misinterpretation or erosion of public trust?

Goodman: The agency staff scientists can continue to, often heroically, present the truth in their analyses, when they are even allowed to (for example, as they did on the hepatitis B birth dose in December's ACIP meeting). But it appears, despite claims to the contrary, that leadership is ignoring or suppressing such input and pursuing an anti-vaccine agenda that amplifies doubts and has caused confusion and mistrust beyond anything they have claimed to be addressing.

Q: Given your ongoing work in public health at Georgetown, what strategies do you believe are most effective for countering misinformation or incomplete narratives around changing vaccine schedules?

Goodman: Until integrity is fully restored to the public health agencies, independent scientists, physicians, and other public health experts and advocates will need to continue to present and clearly communicate their assessments of the available data on disease epidemiology and vaccine risks and benefits, including answering questions being raised, and provide vaccine recommendations independent of the government, as is being done by professional organizations such as the American Academy of Pediatrics (AAP), American College of Obstetricians and Gynecologists, and others.

Q: As accessible frontline vaccinators, how can pharmacists help families navigate shifting recommendations and maintain confidence in the vaccines that remain essential for pediatric protection?

Goodman: Pharmacists and pharmacies are incredibly important vaccine providers and communicators and, while it will take more time and effort, should ensure that the recommendations of expert groups like the AAP, American Academy of Family Physicians, etc, are shared and, also, that any barriers to access are minimized.

Q: Looking ahead, what policy or communication improvements would you like to see to ensure that future vaccine recommendation updates strengthen both scientific credibility and public understanding rather than creating confusion or hesitancy?

Goodman: The integrity of the vaccine assessment and recommendation process, and protection from future political interference, will need to be restored to the government, if possible. It will always be important to have processes of high integrity, engage outside advisors and groups, including medical practitioners, and have full and open discussion of areas of uncertainty.