Abrupt changes in vaccination recommendations by the Centers for Disease Control and Prevention (CDC) and the recently reconstituted Advisory Committee on Immunization Practices (ACIP) have raised alarm among healthcare professionals. Physicians now grapple with uncertainty about how to approach patient counseling, whether vaccines will cost patients more, and whether clinicians face new liability risks.

Last year, Health and Human Services Secretary Robert F. Kennedy, Jr. removed all 17 members of the panel that has provide independent, expert advice on U.S. vaccine policy since 1964—guidelines routinely followed by clinicians nationwide. Since then, his new advisory committee has recommended eliminating the first dose of measles-mumps-rubella (MMR) vaccine combination in children younger than 3 and dropping the recommendation that all children should get vaccinated for hepatitis B at birth.

Then, on January 5, the CDC further gutted its historical vaccination recommendations—acting at the behest of a handful of HHS officials and without any ACIP action. It removed multiple vaccines from the routine pediatric recommendations: hepatitis A and B, meningococcus, rotavirus, respiratory syncytial virus (RSV), influenza and COVID-19. 

The recommendation to cut the hepatitis B vaccine for newborns, in particular, is a dramatic departure from longstanding expert recommendations, as scientific evidence shows the vaccine is highly effective. The move prompted the American Academy of Pediatrics and more than 45 medical societies to reaffirm their support for the vaccination at birth.

“These dramatic shifts in both the substance and process of vaccine policy leave clinicians caught between CDC recommendations and conflicting guidance from medical, public health, and other organizations, raising several pressing questions about legal liability and insurance coverage,” writes Michelle Mello, JD, PhD, a professor of health policy, in a new commentary published in the Journal of the American Medical Association (JAMA.)

The article offers guidance for clinicians concerned over informed consent, liability issues, insurance coverage and protecting their patients against confusion and skepticism.

Mello, who is also a professor of law at Stanford Law School, authored the perspective with Rochelle Walensky, MD, MPH, former head of the CDC in the Biden administration; Michael Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota; and Troyen A. Brennan, MD, JD, MPH, an adjunct professor at Harvard T.H. Chan School of Public Health and former chief medical officer at CVS Health.

“The recent moves by the ACIP and the CDC have sowed confusion, fear and uncertainty among physicians and the public,” they write in the joint JAMA commentary. “The chaos may be part of the strategy for reducing childhood vaccine access. However, changes to the vaccines recommended by ACIP and the CDC need not, and should not, substantially affect clinical practice.”

They explain that healthcare professionals who stick to previous CDC recommendations should not encounter malpractice liability, because many other authoritative organizations continue to recommend the vaccines. When authoritative guidelines conflict, the law recognizes that there may be multiple reasonable standards of care.

The authors also advise that the way physicians counsel patients need not change, since informed consent for vaccines has always been obtained. However, some pediatricians may choose to shift away from a “presumptive approach” (asking for confirmation that a child will receive a vaccine rather than asking what parents think about vaccines) to a more open-ended dialogue—with adverse consequences for vaccine uptake.

“More concerning is the prospect of restrictions on payment by Medicare, Medicaid, and the VFC program, although for appears stable for now,” they write. Going forward, clinicians should stay abreast of payment changes but feel confident in continuing to recommend and administer vaccines in accordance with unswerving professional consensus.

Read the Full Perspective in JAMA