The Vaccine Intelligence Report: December 10-16

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

  • Although the FDA has expanded its investigation into the Covid vaccine, the agency does not plan to add a boxed warning to the shot 
  • New research expands understanding of Covid vaccination and underscores its value 
  • Florida moves forward with its plan to roll back certain vaccine requirements, and West Virginia considers altering its vaccine exemption rules  
  • Flu, measles, and RSV activity continues to rise across the U.S.  

NEED TO KNOW

CDC Adopts ACIP Hepatitis B Vaccine Recommendations Despite Resistance from Physician Groups, Public Health Leaders, and State Health Agencies

  • On Tuesday (December 16), the CDC officially signed off on ACIP’s move away from a universal hepatitis B vaccination recommendation at birth. Federal vaccine guidance now states that infants born to mothers who test positive for hepatitis B should still be vaccinated at birth, but for infants whose mothers test negative, parents should instead discuss with their doctor whether to vaccinate their child. For those who choose to vaccinate, coverage across all payers will not be affected.  
  • The move has been met with resistance at many levels, including from doctors, experts, hospitals, and states: 
    • Over 60 medical, health, and patient organizations decried the change, and the American Academy of Pediatrics (AAP) confirmed that it “continues to recommend giving newborns a dose of the hepatitis B vaccine within 24 hours of birth.”  
    • Hospitals and health systems, including Kaiser Permanente, Children’s National in Washington, D.C., and Colorado’s Denver Health have confirmed that they would continue to offer the shot to all newborns.  
    • Several state health departments and two major regional public health groups, the Northeast Public Health Collaborative and the West Coast Health Alliance, reaffirmed their support for vaccination against hepatitis B at birth.  
  • Universal hepatitis B vaccination at birth had been recommended since 1991 and contributed to a 99% decrease in infections among children and adolescents.  

FDA Expands Review of COVID-19 Vaccines, Says No Changes Planned to Warning Labels

  • Reports last week suggested the Food and Drug Administration (FDA) was considering adding a boxed (“black box”) warning to Covid vaccines, but FDA Commissioner Dr. Marty Makary said in a Monday, December 15 interview that the agency has “no plans” to do so. 
    • A boxed warning is the FDA’s most serious safety label, typically reserved for products associated with severe risks, such as death or permanent disability.  
    • Makary said that while some officials within the agency had raised the idea, FDA leadership and scientific staff—including Dr. Vinay Prasad, the agency’s Chief Medical and Scientific Officer and Director of the Center for Biologics Evaluation and Research (CBER)—did notsupport adding such a warning. 
  • At the same time, the FDA has expanded its ongoing review of deaths potentially linked to Covid vaccines, indicating that vaccine safety remains an active area of focus. The review began in September and initially appeared limited to pediatric cases.  
    • In a memo leaked in late November, Prasad alleged that at least 10 pediatric deaths may have been associated with Covid vaccination, though no data, methods, or case details were provided. The claim drew criticism from experts, who emphasized the absence of supporting evidence. 
  • As with all medical products, Covid vaccines carry some risk of adverse events. However, extensive randomized trials and large real-world studiescontinue to affirm the vaccines’ strong safety profile and effectiveness, with experts consistently concluding that the benefits far outweigh the risks. 
    • Covid infection itself remains significantly more dangerous. The virus has caused more than 1 million deaths in the United States and over 7 million worldwide.  
    • A July analysis estimated that Covid vaccination prevented approximately 2.5 million deaths globally between 2020 and 2024, and more recent research found that vaccinated individuals had a 74% lower risk of death from severe COVID and a 25% lower risk of death overall, regardless of cause. 

New Research Clarifies Covid Vaccine Risks Are Rare and Reinforces Their Benefits

  • Even as the Department of Health and Human Services (HHS) continues to investigate Covid vaccines, new peer-reviewed research is expanding scientific understanding of how the vaccines work—clarifying both their rare risks and their well-documented benefits. 
  • Last week, researchers published new findingsidentifying two immune signaling pathways they believe are involved in the very rare cases of myocarditis (inflammation of the heart muscle) observed after Covid vaccination. Importantly, the researchers also identified a potential mechanism to prevent this side effect.
    • While myocarditis following vaccination is rare, it has received heightened scrutiny from the administration—even though the condition occurs far more frequently, and more severely, after natural Covid infection itself.  
    • The study suggests that vaccine-associated myocarditis is linked to short-lived inflammatory proteins, rather than an allergic or autoimmune reaction, as had previously been speculated.  
    • Typical symptoms of myocarditis include chest pain, shortness of breath, and heart palpitations. Most cases fully resolve on their own, though cases caused by natural Covid infection tend to be more severe than those associated with vaccination.  
  • Separate new research has also shed light on why some individuals never fully recover from natural Covid infection. Scientists studying patients with long Covid identified persistent immune activation and chronic inflammation, offering new insight into the biological underpinnings of the condition and pointing to potential targets for future therapies.  
    • There are currently no approved treatments for long Covid, which affects an estimated 15 million Americans. Vaccination can help prevent long Covid, as it is caused by Covid infection.  
  • At the same time, new evidence continues to underscore the benefits of Covid vaccination: 
    • A CDC report published December 11 found that last season’s (2024-25) Covid vaccines significantly reduced the risk of Covid-associated emergency department and urgent care visits among children. 
    • Another study found that among nearly 20,000 pregnant women who developed Covid, those who were vaccinated were less likely to be hospitalized or require critical care than those who were unvaccinated.  
  • Together, these findings reinforce a consistent conclusion: while rare side effects continue to be carefully studied, Covid vaccination remains a critical tool for reducing severe illness, hospitalization, and long-term health consequences.  

STATE POLICY SPOTLIGHT

Florida Takes Steps to Alter School Vaccine Requirements

  • Following a public meeting on Friday (December 12), Florida health officials signaled they are moving forward with a proposal to roll back certain vaccine requirements for K–12 school and childcare entry, at the direction of Governor Ron DeSantis and Surgeon General Dr. Joseph Ladapo. 
    • The draft rule would scale back requirements for several vaccines, including hepatitis B, varicella (chickenpox), Haemophilus influenzaetype b (Hib), and pneumococcal disease. 
    • Florida already permits medical and religious exemptions, but this proposal would significantly expand parents’ ability to opt out of specific vaccines. 
    • Public health experts raised concerns about the potential impact on vaccination coverage. Florida’s kindergarten vaccination rate currently stands at 89%, below the national average of approximately 92%. Experts warned that loosening requirements could further reduce coverage and increase the risk of outbreaks of highly contagious, vaccine-preventable diseases.
  • Testimony at the meeting reflected deep divisions:  
    • Supporters of the proposal included vaccine-critical organizations, such as the National Vaccine Information Center, along with current and former nurses emphasizing parental rights and medical freedom.  
    • Pediatricians and infectious disease specialists, however, cautioned that the changes could undermine decades of progress in preventing serious childhood illnesses. 
  • Requirements for other vaccines—including measles, polio, and pertussis—are established in state statute and cannot be changed through rulemaking alone. Any revisions to those mandates would require legislative action, potentially during the state’s 2026 legislative session, which begins January 13. 

West Virginia and New York Grapple with Lawsuits Over Religious Exemptions

  • In West Virginia, the state Supreme Court is reviewing a lower court ruling that would require schools to accept religious exemptions to vaccination following a surge in exemption requests.
    • West Virginia has historically maintained one of the strictest vaccine policies in the country, allowing only medical exemptions and prohibiting religious or philosophical exemptions under state law.  
    • The state Supreme Court has stayed the lower court’s ruling while it considers the case, meaning the state’s medical-only exemption system remains in effect for now. 
  • Children’s Health Defense (CHD), an anti-vaccine advocacy group previously led by HHS Secretary Robert F. Kennedy Jr., filed a lawsuit Monday (December 15) against the state of New York over its prohibition of religious exemptions for school vaccine requirements.   
    • The lawsuit alleges that New York’s 2019 law repealing such exemptions violates constitutional rights. “This state-sponsored stigma sends a clear, coercive message to the child: there is something wrong with you and your faith,” CHD wrote in its complaint. 

OUTBREAK OUTLOOK

Measles Cases Continue to Rise as Analysis Highlights Gaps in Early Public Health Messaging

  • Measles cases in the United States continue to climb. As of December 16, the U.S. has reported 1,954 cases this year—an increase of 117 cases since December 5. Several outbreaks remain active: 
    • In upstate South Carolina, cases have risen to 135 across 12 schools, with 168 people currently in quarantine. Governor Henry McMaster has emphasized vaccination as a personal choice and has ruled out vaccine requirements as a control measure. 
    • The outbreak that began along the Utah–Arizona border continues to spread. Outbreak cases reached 114 in Utah and 186 in Arizona as of December 16, with cases appearing in additional Utah counties. 
    • Connecticut reported its first measles case since 2021 on December 11. 
  • Separately, a new analysis suggests that limited federal communication during the early months of the 2025 outbreaks created an information gap, leaving news outlets—not public health agencies—to drive much of the public conversation about measles.
    • From January 1 through August 1, 2025, the CDC posted just 10 measles-related messages across its Facebook, Instagram, and X accounts, compared with an average of 46 posts during the same period in each of the previous four years.  
      • Notably, none of the 2025 posts explicitly promoted the measles, mumps, and rubella (MMR) vaccine, despite vaccination being the most effective way to prevent measles infection. 
    • During that same period, news outlets and anti-vaccine organizations, including Children’s Health Defense, collectively published more than 1,000 measles-related posts.  
    • Researchers warn that the absence of consistent federal messaging may have increased public exposure to misinformation, underscoring the importance of proactive communication from public health agencies during outbreaks.

With Respiratory Illness on the Rise, Officials Emphasize Importance of Flu Vaccination

  • While overall respiratory illness activity remains low nationally, CDC data show that influenza (flu) and respiratory syncytial virus (RSV) are rising across the country. 
    • Flu is increasing in most regions, with the highest activity occurring in Colorado, Louisiana, New Jersey, and New York (specifically New York City). 
    • RSV is on the rise in the Southeast, South, and Mid-Atlantic regions, with emergency department visits and hospitalizations increasing among children ages 0-4. 
    • Covid remains low across the U.S. 
  • Amid increases in flu-related deaths, the CDC and state health officials and providers are urging the public to get their flu vaccine.
    • Last week, the CDC confirmed the first pediatric death of the 2025-26 flu season in Colorado.  
      • In the past week, flu-related deaths among all ages have also been confirmed in Idaho, New Hampshire, and North Carolina.
      • The CDC estimates that there have been at least 2,900,000 illnesses, 30,000 hospitalizations, and 1,200 deaths from flu so far this season. 
    • Health officials emphasize that flu vaccination is the best way to prevent serious illness and death. 
      • The Chief Medical Officer of CDC’s Influenza Division underscored the severity of flu cases and reiterated the CDC’s recommendation for flu vaccination among people ages 6 months and older. 
      • Officials and providers across states, including Georgia, Michigan, North Carolina, and Pennsylvania, also continue to encourage flu vaccination.  

REALITY CHECK

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

CLAIM: For children, the benefits of the Covid vaccine are far outweighed by the risks associated with the shot. 

  • REALITY: The best available evidence shows that Covid vaccines reduce children’s risk of serious outcomes like hospitalization and emergency room visits, and public health and pediatric experts have concluded that for children in eligible age groups, the benefits of Covid vaccination far outweigh any potential risks.  
  • According to a study published by the CDC last week (December 11), last season’s vaccine reduced the rates of Covid-related emergency room and urgent care visits by 76% among children ages 9 months to 4 years old, and by 56% among children ages 5 to 17 years old, compared to peers who were unvaccinated.  
  • By lowering the likelihood that a child gets sick enough to need medical care in the first place, vaccination also reduces the risk of more serious downstream outcomes of Covid infection, including hospitalization and rare but severe complications like multisystem inflammatory syndrome in children (MIS-C), which only occur after infection.  
  • While no medical intervention is completely risk-free, the most common side effects of the Covid vaccine in children are generally mild and temporary (e.g., redness or soreness at injection site, fever) and resolve on their own.  
  • Even the more serious risks associated with the Covid vaccines in children are incredibly rare. The risk of myocarditis (inflammation of the heart), for example, is 0.0027% among males aged 12-24 (the group with the highest risk)—and cases are typically mild, with most individuals recovering fully.  
    • Additionally, CDC follow-up data indicate that rates of myocarditis after vaccination have declined over time and confirm that the large majority of cases resolve, with no known cardiac deaths or need for transplant among those studied.  
    • It should be noted that claims circulating about Covid vaccines leading to pediatric deaths—including implications made in the recently leaked FDA memo—remain unsubstantiatedand neither the FDA nor independent scientists have provided peer-reviewed data demonstrating causation.  
  • By contrast, Covid infection itself has caused thousands of pediatric deaths in the United States since 2020, and continues to pose a risk of severe illness and even death in children—risks that are reduced by keeping children up to date with vaccinations.

CLAIM: Covid vaccination is unnecessary because Paxlovid is an effective treatment. 

  • REALITY: While studies show that treatments like Paxlovid can help reduce the severity of Covid symptoms and outcomes—especially when taken early after infection—the protective effects of these treatments are limited to those who are already infected, meaning it does nothing to prevent individuals from getting infected in the first place or to prevent an infected individual from spreading the virus to others.  
  • Vaccination remains the preferred strategy because it can help prevent infection and in those that are infected can reduce the risk of severe disease or long-term complications like MIS-C and long Covid, which Paxlovid cannot prevent against once an individual is infected.  
    • Treatment options like Paxlovid are important tools, but they do not replace the protection offered by vaccines, which act earlier in the disease process to reduce likelihood of hospitalization, long Covid, and severe outcomes.  
  • Public health and medical experts from leading medical organizations—including American Medical Association (AMA), American Academy of Pediatrics (AAP), and American College of Physicians (ACP)—continue to recommend Covid vaccination as the first line of defense, while recommending treatments as a complementary measure, particularly for those at higher risk, once infection has occurred.   

WHAT TO WATCH

HHS Advisory Commission on Childhood Vaccines to Hold First Meeting in Over a Year

  • The HHS Advisory Commission on Childhood Vaccines (ACCV) will convene on December 29, according to a notice posted in the Federal Register on Tuesday (December 16).
    • The ACCV advises the HHS Secretary on policies and issues related to the National Vaccine Injury Compensation Program (VICP), the no-fault system that provides compensation to people found to be injured by covered vaccines.
    • The Commission is supposed to meet four times a year but has not met since July 2024. Its last scheduled meeting, for January 2025, was postponed indefinitely.
  • The upcoming session will be public and virtual, including discussion only—the Commission will not conduct any voting or decision-making. So far, no agenda has been published.
  • In July, Kennedy announced plans to reform the VICP, and HHS is reportedly working on policy changes that would broaden the covered injuries to include autism symptoms.

American College of Physicians to Host Hill Briefing on Vaccine and Public Health Communications

  • On January 6, the American College of Physicians (ACP) will convene a Capitol Hill briefing featuring speakers representing ACP, National Foundation for Infectious Diseases, vaccine manufacturer GSK, and a Vaccinate Your Family advocate who lost her infant to pertussis.
  • The event will cover the safety and efficacy of vaccines, discussing the importance of both accurate public messaging surrounding vaccines and basing vaccine recommendations on scientific research and data.

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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