The Vaccine Intelligence Report: November 19-December 2

The Vaccine Intelligence Report—brought to you by Vaccinate Your Family—provides clear, fact-based updates on vaccine policy, research, and public health each week. This report is part of Viral Truths, a resource designed to cut through the noise, offering concise information to help navigate the evolving immunization landscape.

THIS WEEK AT A GLANCE

  • In a leaked memo, the FDA’s Director of the Center for Biologics Evaluation and Research (CBER) claimed that the Covid vaccine caused child deaths, raising concerns among experts; evidence to support this claim has not yet been shared
  • During the Thursday-Friday meeting, ACIP is expected to consider whether to delay the recommended hepatitis B birth dose—an independent review found this would offer no increase in safety or protection
  • Kennedy is considering major changes to the Vaccine Injury Compensation Program, which experts warn could bankrupt the program and disrupt the vaccine supply chain
  • The U.S. has reached 1,800 measles cases this year, and the WHO warns that surges in the disease foreshadow likely increases in other vaccine-preventable diseases

NEED TO KNOW

Leaked FDA Memo Cites Unverified Child Deaths, Sparking Scrutiny and Concern

  • In an internal memo that was leaked last week (November 28), Dr. Vinay Prasad, the Director of the FDA Center for Biologics Evaluation and Research (CBER), made claims that Covid vaccines caused “at least 10” child deaths, citing a review of 96 reports of pediatric deaths from the Vaccine Adverse Events Reporting System (VAERS) database but providing no data, methods, case details, or evidence to back the claim.
    • While Prasad does mention myocarditis in the memo, he does not explicitly specify what conditions or mechanisms he believes caused the alleged vaccine-associated deaths and provides no explanation of how the FDA concluded causation, nor any supporting clinical details.
    • Of note, the memo does not mention any regulatory action from the FDA in response to the allegations. In past cases where a verified safety signal was identified—such as in 2021 with the Johnson & Johnson Covid vaccine—the agency has issued temporary pauses on use while conducting formal reviews.
  • Numerous experts—including former FDA leadership, pediatric cardiologists, epidemiologists, and vaccine safety researchers—immediately raised concerns, calling the claim “extraordinary” and “irresponsible” without transparent evidence, and noting that the VAERS reports are unverified and cannot be used to determine causality.
  • Further, career FDA and CDC officials expressed alarm that Prasad’s conclusions depart from established scientific standards and appear to reflect the broader political positioning of the agency’s new leadership, with multiple staff members calling the memo “misleading” and “politically charged.”
  • Prasad also proposed using these unsubstantiated claims as a basis for broader shifts in vaccine regulation—including stricter evidence requirements for future vaccines, reevaluating the administration of multiple vaccines at the same time, and changing the way the annual flu vaccine is evaluated.
    • Experts noted that current vaccine approval standards are already rigorous and supported by extensive safety and efficacy data, and that Covid vaccines were no exception.
    • Former FDA officials also warn that these changes could slow vaccine approvals, undermine longstanding scientific processes, chill innovation by making even routine vaccine updates far more burdensome, and further erode vaccine confidence—all without scientific justification.
  • Many current and former regulators believe that the sweeping claims made in the memo, its distribution to the entire center, and Prasad’s closing challenge to staff who disagreed to submit resignations, suggest it was written with the expectation it would leak, heightening concerns about internal pressure and politicization of vaccine oversight.
  • The leaked memo comes just days before a closely watched meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP), where members are expected to consider several changes to the childhood vaccine schedule—underscoring how Prasad’s memo aligns with wider attempts to challenge established vaccine standards without scientific support.

Expert Review Reaffirms Safety and Lifesaving Benefits of Hepatitis B Birth Dose as ACIP Weighs Potential Delay

  • On December 4–5, ACIP will convene to review several topics, including the hepatitis B vaccine and updates to the childhood and adolescent immunization schedule.
  • The Committee is expected to vote on whether to delay the longstanding recommendation for universal hepatitis B vaccination at birth, which has contributed to a 99% decline in new infections among children and teens since 1991.
    • At its September meeting, ACIP discussed postponing the birth dose to one month or later, but ultimately tabled the decision.
    • Also of note: on Tuesday (December 2), Cynthia Nevison, a climate researcher with ties to anti-vaccine organizations, was named as a contractor to ACIP’s hepatitis B work group. Typically, subject matter experts are brought in to help work groups review data, raising questions about why Nevison was tapped, given her work primarily focuses on climate science.
  • Ahead of this week’s meeting, the Vaccine Integrity Project released an independent, comprehensive review of the evidence on the hepatitis B birth dose. The review found no benefit—either related to vaccine safety or the protection offered—in delaying the first dose.
    • Researchers assessed more than four decades of data, including randomized trials and multiple studies directly comparing vaccination at birth versus at one month or older.
  • The findings emphasize that delaying the first dose leaves newborns unnecessarily vulnerable to undiagnosed maternal infection, to false-negative test results, and to exposures that occur after birth. The analysis also reinforces why past attempts at a risk-based strategy—which some opponents of universal vaccination would like to return to—failed to protect infants.
    • Nearly 20% of pregnant women are not screened for hepatitis B despite universal recommendations, and only about one-third of those who test positive receive all recommended care.
    • Even when screening occurs, infants remain at risk if the mother acquires infection later in pregnancy or if test results are inaccurate. Unvaccinated newborns are also susceptible to exposure from household or community contacts after birth.
  • While opponents of the universal birth dose often point to countries like Denmark that do not vaccinate all newborns, Denmark’s extremely low hepatitis B prevalence and highly reliable prenatal screening make a targeted approach feasible there.
    • In contrast, the U.S. faces a far higher burden of chronic, often undiagnosed infection—more than 2 million Americans live with hepatitis B, half unaware they are infected—and an estimated 1 in 6 pregnant women are not properly screened, making a universal birth-dose the only reliable strategy to protect newborns.

HHS Weighs Major Changes to Vaccine Injury Compensation Program

  • HHS Secretary Robert F. Kennedy Jr. is weighing major changes to the Vaccine Injury Compensation Program (VICP)—the no-fault system established in 1986 to fairly compensate individuals with legitimate vaccine injuries while preserving a stable vaccine supply. Proposed changes include expanding eligible conditions and removing certain vaccines from the program.
    • Last week (November 26), a now-withdrawnFederal Register notice indicated the commission advising the VICP would meet December 15-18, but it’s unclear if it will occur or what may be on the agenda.
  • Kennedy’s senior advisor, Drew Downing, is reportedly developing a proposal to add autism-related symptoms to the VICP. Currently, the program only covers specific set of vaccine side effects that, while rare, are supported by strong scientific evidence.
    • Instead of explicitly naming autism, HHS may broaden the definition of neurological injury—specifically “encephalopathy”—to allow children with autism-like symptoms to qualify. This would contradict decades of research showing no causal link between vaccines and autism.
  • Experts warn that expanding VICP to include autism could lead to tens of billions in annual claims, overwhelming a program that collects roughly $250 million per year and holds $4 billion in reserves. Such strain could bankrupt the fund, jeopardize compensation for individuals with legitimate vaccine injuries, and disrupt the vaccine supply.
  • Kennedy allies have also floated removing certain vaccines from VICP coverage, effectively shifting related injury claims from the specialized vaccine court to traditional civil courts.
    • For a vaccine to be covered, the CDC must recommend it for routine administration to children or pregnant women, and the CDC’s recommendations are based on input from the ACIP.
    • Experts emphasize that these proposals do not address the program’s real shortcomings, such as staffing shortages and slow case processing, and argue that reforms should focus on adding resources—particularly more special masters—to improve efficiency.

OUTBREAK OUTLOOK

U.S. Measles Cases Reach 1,800 as Outbreaks Intensify in Several States

  • As of November 28, the U.S. reached 1,800 total measles cases this year, with new cases largely concentrated in existing outbreaks.
    • Along the Utah-Arizona border, total Utahmeasles cases for the year reached 105 as of Monday (December 1) and continue to spread further north. Arizona has recorded 153 total cases this year, nearly all of which occurred in Mohave County.
    • In upstate South Carolina, 62 cases have been reported as of November 28. State officials say that despite recent efforts, like mobile clinics, to increase vaccination amidst the ongoing outbreak, uptake has been slow. They point to false information spreading about vaccines, as well as increases in school vaccination exemptions, as major contributors.
  • The CDC’s most recent Respiratory Illness Updatenotes that Covid, flu, and respiratory syncytial virus (RSV) remain low, but are growing in some parts of the country.
    • Specifically, RSV activity is increasing in southeastern and southern states, with emergency department visits increasing among children under four years old.
    • Flu activity is increasing in children and young adults nationwide.

WHO Warns of Rising Measles Threat and Signals Broader Risk for Other Vaccine-Preventable Diseases

  • A new World Health Organization (WHO) reportshows that global measles deaths fell by 88% between 2000 and 2024, a remarkable achievement driven largely by measles vaccination, which has saved nearly 59 million lives since 2000.
  • Despite this progress, the report warns that current vaccination coverage is insufficient to protect communities. Measles outbreaks are increasing in size and frequency: 59 countries experienced large or disruptive outbreaks in 2024—almost triple the number in 2021—and an estimated 95,000 people died from the disease.
    • The WHO now describes its global measles elimination goal as “distant,” citing declining vaccination rates worldwide, including in high-income countries that had previously eliminated measles.
  • WHO officials cautioned that surges in highly contagious diseases such as measles often foreshadow increases in other vaccine-preventable diseases.
    • Because measles is so transmissible, it is typically the first disease to spread when vaccination rates fall—one infected person can transmit measles to up to 90% of nearby unvaccinated people.
    • Declines in measles vaccination often reveal broader gaps in immunization, raising the risk of outbreaks of diphtheria, pertussis (whooping cough), and polio.
      • This year, the U.S. has already recorded 25,000 cases of whooping cough and deaths, including three infants in Kentuckywho were unvaccinated.

REALITY CHECK

These fact checks respond to several recent claims made by different groups and individuals.

CLAIM: We do not have strong or high-quality evidence to demonstrate the safety and efficacy of flu vaccines.

  • Flu vaccines do not always prevent flu infection, but studies consistently show that vaccination reduces the risk of severe illness, complications, hospitalization, and death. For example:
    • According to a study of the 2022–2023 flu season in the U.S., vaccinated adults aged 18–64 were 47% less likely to be hospitalized with the flu than unvaccinated adults.
    • Another study modeling the 2017-2018 respiratory illness season found that flu vaccines helped avert an estimated 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations, and 8,000 flu-related deaths in the U.S.
    • Research has also shown that flu vaccination reduces complications and longer-term adverse health outcomes, with studies linking vaccination to lower risk of cardiovascular events, lower all-cause mortality in populations with chronic conditions like diabetes and hypertension, and lower incidence of pneumonia and other severe respiratory complications.
  • Because the viruses that cause flu mutate often and the dominant strains that circulate can change each year, the effectiveness of flu vaccines can vary from season to season depending on how well the vaccine strains match the circulating viruses.
    • Nonetheless, even in years with imperfect matches, vaccination can still provide protection that has been shown to reduce risk of illness, medical visits, hospitalization, and serious complications.
  • Additionally, there is also a large body of research demonstrating that flu vaccines are largely safe and that any potential risks associated are far outweighed by the benefits of the vaccine. For example:
    • A recent large post-market surveillance study of nearly 10 million flu vaccine recipients (between the ages of 6 months and 64 years) found no statistically significant increase in serious adverse outcomes following vaccination.
    • Studies published in the Journal of American Medicine and other peer-reviewed journals, as well as reports from the CDC evaluating over 50 years and hundreds of millions of administered doses in the U.S., maintain that flu vaccines have a very strong safety record, and that overwhelmingly side effects associated with these vaccines are mild (e.g., injection site soreness, temporary fever, or aches), and serious reactions are extremely rare.

CLAIM: Vaccine manufacturers are exempt from liability for harms caused by their products.

  • REALITY: While it’s true that there are some legal protections in place to help ensure vaccine makers can keep approved vaccines available to the public, manufacturers are not completely shielded from liability—they can still be sued in civil court for major wrongdoing like fraud or breaking manufacturing rules.
    • Further, there are systems in place to compensate individuals who experience vaccine injury, as well as systems that monitor safety on an ongoing basis, making the situation more nuanced than the simple claim that “vaccine manufacturers are exempt from liability.”
  • Most claims related to vaccine injury are handled through the National Vaccine Injury Compensation Program (VICP), which is a no-fault system that provides a more direct, faster, and less burdensome path to compensation for people who experience rare vaccine-related injuries.
    • The VICP does not require the person claiming injury to prove negligence and is specifically designed to make it easier for injured individuals to receive compensation, while also maintaining the stability needed to keep approved vaccines widely accessible to the public.
    • Additionally, if an individual is not satisfied with the outcome of the claim filed with the VICP, petitioners may choose to reject the finding of the special master and pursue compensation in civil court.
    • Moreover, systems like the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink track safety signals to ensure that if rare side effects or problems emerge, they are quickly detected and addressed. Every vaccine must meet rigorous FDA standards prior to and following approval.

CLAIM: We have not carried out enough research—and therefore do not fully understand the risks—related to administering multiple vaccines at the same time.  

  • REALITY: Contrary to the claim above, decades of clinical trials, observational studies, and real-world immunization practice have evaluated the risks, benefits, and efficacy associated with administering simultaneous (coadministration) or closely spaced vaccines. 
  • The Institutes of Medicine (IOM), for example, undertook the most comprehensive examination of childhood immunizations to date in 2013, and found “no evidence of major safety concerns associated with adherence to the childhood immunization schedule”.
  • Extensive efficacy research on coadministration has also been carried out and has found that when multiple vaccines are given together their effectiveness remains intact. In other words, when administered simultaneously, the immune response and protection provided by vaccines remains comparable to when vaccines are given separately.
    • Importantly, research also shows that coadministration can increase the likelihood that recommended vaccine series are completed, as giving all needed vaccines during a single visit reduces the number of medical visits required, lowers the chance of missed or delayed doses, and helps ensure people are up to date with their immunizations.
  • Based on this extensive evidence, leading public health and pediatric authorities—including the American Academy of Pediatrics—indicate that coadministration is safe and effective, simultaneous administration of all recommended vaccines should be standard practice, and that there is no scientific or medical reason to delay or spread out vaccines.

WHAT TO WATCH

This Week’s ACIP Meeting (December 4-5, 2025)

  • ACIP’s Thursday and Friday meeting agendaincludes the hepatitis B vaccine, the childhood/adolescent immunization schedule, and “adjuvants and contaminants.”
    • The group is expected to vote on whether to delay hepatitis B vaccination, which is currently recommended for all infants at birth and considered essential in preventing childhood infections.
    • Their discussion on adjuvants will likely center around aluminum, which has come under heightened scrutiny by this administration, despite decades of safety data.
    • It’s unclear what “contaminants” refers to, but it may indicate that the committee intends to revisit unsubstantiated claims about “DNA impurities” in vaccines. Two ACIP members presented a widely discredited review on the topic at the September meeting, asserting “safety uncertainties” around mRNA Covid vaccines.

Vaccinate Your Family is a nonpartisan organization dedicated to protecting people of all ages from vaccine-preventable diseases. To learn more, visit us at: vaccinateyourfamily.org

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