The Vaccine Brief: COVID Vaccine Limits, CDC in Crisis, and Liability Questions

What Matters This Week, August 28

I’m David Higgins, a practicing pediatrician and preventive medicine physician who cares for children and studies how to improve how we communicate about and deliver vaccines and other preventive care. This newsletter shares clear science, smart policy, and meaningful conversations, because the health of our communities depends on all three.

---

Photo by Ian Hutchinson on Unsplash

Hi community,

This week has been extraordinary for vaccine policy and public health. Here’s a mid-week update.

---

Narrowed approval of COVID-19 vaccines

I wrote for The Conversation about the FDA’s August 27 approval of updated COVID-19 vaccines for the fall—but only for high-risk children:

• Moderna: 6 months+

• Pfizer: 5 years+

• Novavax: 12 years+

• All are limited to kids with underlying health conditions.

Until now, all children 6 months and older could get Pfizer or Moderna, and all adolescents could receive Novavax.

This rollback means young children may face increased barriers to vaccination, even as they continue to experience hospitalizations and deaths at levels similar to influenza—an illness for which vaccination is routine.

The change comes as we see diverging guidance:

• The CDC no longer routinely recommends COVID-19 vaccination for healthy kids aged 6 months to 17 years, instead leaving it to “shared clinical decision-making.”

• The American Academy of Pediatrics (AAP), by contrast, recommends it for all children 6–23 months and for higher-risk kids 2–18, while supporting access for any family who wants protection.

These shifts leave providers and parents grappling with new complexity—just as COVID cases climb again this summer.

Read my full piece in The Conversation

---

Leadership shake-up at CDC

The policy turbulence deepened yesterday when the director of the CDC was fired, and several other top officials have stepped down. President Trump removed CDC Director Susan Monarez after HHS Secretary Robert F. Kennedy Jr. attempted to oust her earlier in the day without authority.

The resignation letters of several of these career scientists made the stakes clear:

I am unable to serve in an environment that treats CDC as a tool to generate policies and materials that do not reflect scientific reality and are designed to hurt rather than to improve the public’s health. - Dr. Demetre Daskalakis MD MPH, Director of the National Center for Immunization and Respiratory Diseases

For the good of the nation and the world, the science at CDC should never be censored or subject to political pauses or interpretations. Vaccines save lives—this is an indisputable, well-established, scientific fact. - Deb Houry, MD, MPH, Chief Medical Officer and Deputy Director for Program and Science

Read more of the letters at Inside Medicine by

Jeremy Faust, MD

.

---

Physician liability in a shifting policy landscape

The FDA’s narrowed approvals raise a common question I’m hearing from physicians who are understandably concerned, given that the Secretary of Health and Human Services has posted misleading claims: If I give a COVID vaccine “off-label,” do I face increased liability?

Here’s a quick Q&A based on legal experts I’ve consulted:

• Is off-label use illegal?

  No. About 1 in 5 prescriptions are off-label. However, while physicians can give vaccines off-label, pharmacists and other non-physicians may not be able to do so in many states.

• Could I face malpractice or discipline?

  Only if a court or board finds you deviated from the standard of care.

• What defines the standard of care?

  Professional consensus, respected guidelines, and clinical judgment—not just FDA labels or ACIP recommendations. It would be difficult to argue that following AAP or the American College of Obstetricians and Gynecologists (ACOG) guidance falls outside the standard of care.

• Are there special protections?

  • Most childhood vaccines: Covered by the Vaccine Injury Compensation Program (VICP), a no-fault system funded by an excise tax. The VICP already doesn’t cover every vaccine (e.g., adult-only and travel vaccines, RSV monoclonal antibodies).

  • COVID vaccines: Currently covered by the Countermeasures Injury Compensation Program (CICP) under the PREP Act. Intended to provide broad immunity, but multiple federal courts have narrowed those protections, allowing some malpractice claims to proceed.

• So am I immune from liability?

  No. VICP and CICP/PREP Act provide important protections, but they don’t stop state boards from investigating or eliminate all risk. The best protection is practicing within professional standards and documenting decisions.

(Disclaimer: I’m not a lawyer; this is not legal advice. These points reflect conversations with legal experts. I look forward to sharing more insights from legal experts to help providers feel confident following best practices for vaccination without undue concern.)

---

Looking ahead

The CDC’s recommendations—including those considered “high risk” for COVID-19—could shift again after the September ACIP meeting. But this is no ordinary ACIP: Kennedy dissolved the committee earlier this year and replaced it with members he selected, including vaccine skeptics. The COVID vaccine work group is chaired by someone without biomedical training who is an outspoken vaccine critic.

With the CDC director gone, top scientists resigning, and guidance fractured, I am afraid federal vaccine guidance is stumbling forward in the dark.

---

Why this matters

• Parents want clarity: Can my child get vaccinated this fall?

• Physicians want confidence: Can I offer vaccines?

• The public wants credibility: Who speaks for science?

Throughline: Chaos undermines trust.

That’s why AAP, ACOG, and other independent expert groups are stepping up with evidence-based recommendations. And it’s why families need strong partnerships with pediatricians to navigate the confusion.

---

👉 Bottom line: With new FDA restrictions, CDC leadership in disarray, and liability questions swirling, vaccine policy is entering uncharted territory.

Thanks, as always, for being part of this community.

-David

Do you like this newsletter?

Then you should subscribe here for FREE to never miss an update and share this with others:

You can also follow me on LinkedIn, Instagram, Substack Notes, and Bluesky.

Community Immunity is a newsletter dedicated to vaccines, policy, and public health, offering clear science and meaningful conversations for health professionals, science communicators, policymakers, and anyone who wants to stay informed. This newsletter is free for everyone, and I want it to be a conversation, not just a broadcast. And if you find this valuable, please help spread the word!