Update: ACIP meeting adds to COVID-19 vaccine confusion

Originally published on Aug. 28, 2025

The U.S. Food and Drug Administration (FDA) has approved updated Moderna and Pfizer COVID-19 vaccines that target the LP.8.1 variant of SARS-CoV-2 for only some people. This limited approval adheres to the controversial framework published in May by FDA Commissioner Dr. Martin Makary and FDA Center for Biologics Evaluation and Research Dr. Vinay Prasad.

Here are the changes in approval and authorization:

• Spikevax (Moderna):
  • Previously approved for all people 12 years of age and older and for children 6 months to 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
  • Now approved for:
    • Individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
    • All adults 65 years of age and older.
• mNEXSPIKE (Moderna):
  • A new, redesigned COVID-19 mRNA vaccine that targets specific areas of the spike protein instead of the entire spike protein (which Spikevax targets). Allows for a lower dosage of the active ingredient.
  • Approved for:
    • Individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
    • All adults 65 years of age and older.
• Comirnaty (Pfizer):
  • Previously approved for all people 5 years of age and older. Previously authorized for all children 6 months to 4 years of age.
  • Now approved for:
    • Individuals 5-64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
    • All adults 65 years of age and older.
    • The emergency use authorization (EUA) for Comirnaty for all children ages 6 months to 4 years old has been revoked.

The result of these changes is that there is now no updated COVID-19 vaccine that is approved for children or adults under 65 who do not have a high-risk condition. Because any medication that is not specifically approved for a particular group of people can only be given “off-label,” it may be difficult for these people to actually get the updated vaccine, even as a booster.

“There is a particular concern for family members of immunocompromised individuals who are healthy and under 65 but could put household members at risk,” said IDF Chief Policy Officer Lynn Albizo.

Healthcare providers routinely use medications off-label in certain contexts and insurance companies may cover off-label use if it is the standard of care. However, providers and insurance companies may be unwilling (or, in the case of pharmacists, legally unable) to do so for the updated COVID-19 vaccine given the political climate. In a statement, the Infectious Disease Society of America urged physicians to prescribe and recommend the updated vaccines off-label. Check with your insurance plan to confirm coverage.

It also remains unclear which underlying conditions will qualify someone younger than 65 for the updated vaccines. For example, Makary and Prasad listed pregnancy as a qualifying condition in their FDA approval framework, but U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., has said that the Centers for Disease Control and Prevention (CDC) will no longer recommend the vaccine for pregnant individuals who do not have another condition.

Several medical organizations have recently broken with HHS over COVID-19 vaccines and boosters. The American Academy of Pediatrics recommends that all children ages 6-23 months of age, whether or not they have any health conditions, receive the shots because this age group is most likely to have severe symptoms. Likewise, the American College of Obstetricians and Gynecologists recommends that pregnant individuals receive the most up-to-date COVID-19 booster sometime during their pregnancy.

Originally published on July 29, 2025

Arielle Mitchell lives with a primary immunodeficiency (PI) that is fatal unless treated regularly. Diagnosed with ADA-severe combined immunodeficiency (SCID), she takes weekly infusions of enzyme replacement therapy (ERT) and avoids people who are sick. Because vaccines aren’t effective for her, she relies on others, like her family, being vaccinated for protection.

“My family knows about it, my co-workers know about it, but as far as everyday people, they don’t. So I really rely on that herd immunity,” said Mitchell.

Herd immunity is when enough people in a community are immune to a disease that it’s difficult for the disease to spread from person to person. Because most people in the U.S. choose to get vaccinated, herd immunity exists for diseases like measles, mumps, polio, and chickenpox without large swaths of the community suffering through these diseases and their complications—including death.

Herd immunity is essential for people with PI. Unlike others who can expect to be protected after getting a vaccine, many people with PI don’t respond to vaccines.

For decades, people with PI and other immunocompromising conditions; older adults, whose immune systems are generally weaker; infants, who cannot receive vaccines until a certain age; those who have severe allergic reactions to vaccines; and those undergoing treatment with chemotherapy or steroids (that impair the immune system) have benefited from the protection others provide through vaccination.

“More than 14 million people under 65 are immune-compromised in the U.S., and those over 65 naturally have weaker immune systems. Someone you know—a family member, an elderly neighbor, your friend’s baby—is at risk if we don’t maintain herd immunity,” said Immune Deficiency Foundation (IDF) Chief Policy Officer Lynn Albizo.

Now that protection is under threat. U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr., and members of his administration are incrementally dismantling vaccine policy and recommendations that scientists have spent decades building to keep the public safe from disease. At the same time, the administration is sending mixed messages about vaccines, sowing uncertainty and skepticism.

In May, under Kennedy’s leadership, the Food and Drug Administration (FDA) issued a new framework for the approval of COVID-19 vaccines. The framework calls for vaccine manufacturers to conduct clinical trials to see if healthy persons aged 6 months to 64 years should receive COVID-19 vaccines.

Researchers have already conducted clinical trials for the COVID-19 vaccine over the last several years, making the trials required in the framework not only unnecessary but also unethical because some people in the trial will receive a placebo instead of the vaccine, putting them at risk of COVID-19. This framework appears to have had no input other than that of FDA Commissioner Dr. Martin Makary and former FDA Center for Biologics Evaluation and Research head Dr. Vinay Prasad.

Currently, some COVID-19 2024-2025 vaccines are still available for those 12 and up, but that could change for the next vaccine season.

Kennedy also announced that the Centers for Disease Control and Prevention (CDC) no longer recommends the COVID-19 vaccine for healthy children ages 6 months to 18 years or pregnant women. Interestingly, the FDA framework specifically lists pregnancy as a health condition warranting COVID-19 vaccination for healthy individuals.

To make matters even more confusing, FDA researchers recommended full approval of a COVID-19 vaccine, Novavax, in April. Novavax is the only non-mRNA vaccine for COVID-19 available in the U.S. Then, FDA’s Acting Principal Deputy Commissioner, a political appointee, paused the decision, and eventually approved it only for adults age 65 and older and those 12-64 with additional conditions that put them at greater risk. Interference by a political appointee into scientific assessments by career FDA staff, who review data on drugs and vaccines seeking approval, is highly unusual.

Further undermining vaccine progress, in June, Kennedy dismissed all 17 members of the Centers for Disease Control’s (CDC) vaccine advisory panel, known as the Advisory Committee on Immunization Practices (ACIP). The ACIP makes recommendations on the safety, effectiveness, and need for vaccines. The panel’s decisions influence the CDC's immunization schedule and insurance coverage for vaccines. During his confirmation hearing, Kennedy gave Congress his word that he would not interfere with ACIP. Kennedy then filled the vacant positions with eight appointees (one of whom left), who lack qualifications and are outspoken critics of certain vaccines.

At the June 2025 ACIP meeting, the new appointees geared up to challenge well-established childhood vaccines. According to a statement by the National Association of Pediatric Nurse Practitioners, the ACIP formed workgroups to review proven vaccines and the cumulative effects of the childhood and adolescent vaccine schedules. Studying the cumulative effects of vaccines using randomized controlled studies in which vaccines are withheld from a control group of children puts those children at risk and is unethical.

The new ACIP appointees also scrutinized the timing of the measles, mumps, and rubella (MMR) vaccine, and questioned the inclusion of the varicella vaccine with MMR, why the HepB vaccine is given to newborns, and measles vaccine ingredients.

“I am concerned that the direction the administration is going regarding vaccines will put our community and others who are immunocompromised at risk. The premature replacement of well-qualified members of the Advisory Committee on Vaccine Practices (ACIP) and the inconsistent messages from the Secretary of Health and Human Services and the departments under his direction are two examples of the confusion that we have seen,” said Albizo.

“As our leaders have done for over 60 years, we need the administration to ensure vaccine access and encourage broad immunization among the American population so that our family members, young and old, are able to remain healthy.”

A lack of clear, evidence-based vaccine recommendations weakens the public’s confidence in choosing to vaccinate. It also gives insurance companies an excuse not to cover the cost of vaccines. That results in further inequities in healthcare, leading to a scenario where those who can afford vaccines obtain them and those who cannot risk infection.

“As an immunologist who treats adults and children with immunodeficiencies, I am deeply concerned about the recent efforts by the administration to question the safety and effectiveness of vaccines. Vaccines are among the most rigorously studied and monitored medical interventions in history. Their safety profiles are well-established, and their role in preventing serious illness, disability, and death cannot be overstated,” said immunologist Dr. Reena Mehta.

“When public figures or policymakers cast doubt on vaccines without scientific justification, this can lead to lower vaccination rates, which in turn increases the risk of outbreaks of preventable diseases like measles, polio, or pertussis. As an immunologist, I’ve seen firsthand the suffering caused by vaccine-preventable illnesses. I’ve also witnessed the peace of mind and protection vaccines offer families, especially those with vulnerable members such as infants, the elderly, or the immunocompromised.”

The weak federal response to a continued measles outbreak in Texas shows how quickly diseases spread among populations that opt out of immunizations. The outbreak started in a small Texas community with low vaccination rates in January 2025 and quickly spread to nearby towns and then to other states. Measles cases in the U.S. are now higher than in any year since 1992. As of July 22, 2025, the Centers for Disease Control (CDC) and Prevention reports 1,319 cases of measles, with 92% of those cases occurring in unvaccinated persons. More than 160 people have been hospitalized, and three have died.

“Some of my patients are worried about the increasing spread of vaccine misinformation and declining public trust. They ask me, ‘Will others still vaccinate their children?’ or ‘Is it safe for me to go out if fewer people are getting vaccinated?’ These aren’t hypothetical concerns—they’re real, deeply personal fears for their safety,” said Mehta.

“Others face barriers to accessing the vaccines they need—whether it’s due to insurance coverage, logistical hurdles, or confusion about changing guidelines. For those managing complex medical conditions, any delay in vaccination can be dangerous.”

Mitchell expressed disappointment about how many people who can get vaccinated choose not to do so. She worries about what the future holds for herself and others if access to vaccines is restricted.

“I don’t want to sound harsh, but for those who don’t think about anybody else, it’s just very disheartening, not just for the PI community but for other people with chronic diseases, too,” said Mitchell.

The federal government’s discrediting of vaccines has not been without protest from the medical community, insurers, advocacy organizations, and the general public.

• Thirty-four scientific and medical organizations, led by the American Association of Immunologists and the American College of Physicians, released a coalition statement in support of the impact and safety of vaccines.
• The health insurance trade association AHIP (America’s Health Insurance Plans) issued a statement stating that insurers are committed to continued coverage of vaccines.
• The American Academy of Pediatrics announced it will no longer participate in the ACIP meetings because the advisory committee’s process is no longer credible, and instead, will continue to publish its immunization schedule as it has done for decades.
• Some states may broaden their own laws to allow their public health departments to use non-ACIP recommendations.
• Six medical groups sued HHS and HHS Secretary Robert F. Kennedy Jr. for acting “arbitrarily and capriciously” when he made recent changes to COVID-19 vaccine policy. The suit states, “the administration is an existential threat to vaccination in America” and their actions could “unleash a wave of preventable harm on our nation’s children.”

IDF has joined pro-vaccine coalitions in specific states to defend against anti-vaccine legislation and is working to educate legislators at both the state and federal levels. IDF also plans to hold workshops in states where vaccine skepticism is high.

Mehta wants Kennedy and the administration to know that vulnerable populations depend on the protection vaccines offer, and they will be at the most risk if vaccine access is reduced.

“As an immunologist and physician who cares for immunocompromised children and adults every day, I see the very real consequences of vaccine hesitancy. My patients—many of whom are battling cancer, autoimmune diseases, or were born with immune deficiencies—rely not only on their own limited defenses, but on the health of their communities. When vaccination rates drop, these patients suffer. They’re the first to be hospitalized when preventable infections spread, and sometimes they don’t survive what should be a manageable illness. For them, vaccines aren't a personal choice—they're a collective lifeline,” said Mehta.

Mehta said if given the chance to speak with Kennedy, she would tell him that she cares deeply about the public’s health and safety, just as he does, and that she understands that he is concerned about vaccine safety and transparency, and that there should be rigorous oversight.

“But decades of data, thousands of studies, and global health outcomes consistently show that vaccines are among the safest and most effective tools we have. And while no medical intervention is risk-free, the risks of not vaccinating—especially for the vulnerable—are far greater,” said Mehta.

“You have a powerful platform, and people listen to you. If you helped shift the conversation toward evidence-based trust in vaccines, you could save lives, especially of those who cannot speak for themselves: the infants too young to be vaccinated, the elderly with failing immune systems, the child on chemotherapy.

“From one person committed to health advocacy to another—I truly hope you'll help rebuild public trust in vaccines. Science and compassion can and should go hand in hand.”