HHS bars medical organization liaisons from ACIP vaccine reviews

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Physician groups no longer will be part of deliberations of the nation’s Advisory Committee on Immunization Practices (ACIP), according to the American Medical Association (AMA).

Meanwhile, former ACIP members publicly outlined their procedures and argued the reconstituted panel cannot match their rigorous consideration of vaccine science.

Doctors’ groups fired another volley of criticism at the U.S. Department of Health and Human Services in the continuing fight over national reviews and recommendations of vaccines.

On Aug. 1, AMA announced the ACIP liaison organizations were notified via email late July 31 that they “will be excluded from the process of reviewing scientific evidence and informing vaccine recommendations.”

The organizations’ statement did not name the current ACIP members, Health and Human Services Secretary Robert F. Kennedy, Jr., who has expressed skepticism about vaccine safety, or his boss, President Donald J. Trump. But the doctor groups said the move was sure to undermine public and clinician trust in vaccines.

AMA issued a statement for itself with the American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Geriatrics Society, American Osteopathic Association, Infectious Diseases Society of America, and the National Medical Association.

What did they say?

“We are deeply disappointed and alarmed that our organizations are being characterized as ‘biased’ and therefore barred from reviewing scientific data and informing the development of vaccine recommendations that have long helped ensure our nation’s vaccine program is safe, effective, and free from bias,” the medical organizations said. “We represent physicians who care for patients throughout their lifespan, who share a common goal and responsibility to keep patients healthy and protect public health. We bring to the table real-world clinical experience on how vaccine recommendations are implemented in practice.

“For decades, liaisons from our organizations have reviewed published and unpublished data and literature related to vaccine efficacy, effectiveness, and safety and provided unbiased input for ACIP’s consideration,” the joint statement said. “To remove our deep medical expertise from this vital and once transparent process is irresponsible, dangerous to our nation’s health, and will further undermine public and clinician trust in vaccines. We strongly urge the administration to reconsider excluding our organizations from participating in the ACIP vaccine review process so we can continue to feel confident in its vaccine recommendations for our patients.”

A seat at the table?

The ACIP move appeared sure to widen the rift between the nation’s single largest health regulatory agency and the physicians and other clinicians who have argued against its changes to the vaccine evaluations.

In June, representatives of the American Academy of Pediatrics (AAP) boycotted the two-day meeting of ACIP, the first with new members appointed by Kennedy. In July, the American College of Obstetrics and Gynecology announced it would publish its own recommendations for COVID-19 vaccines and other inoculations. The Guardian has reported AAP, the Infectious Diseases Society of America, AAFP and ACP all will issue their own vaccine guidance in coming times.

ACIP members speak

The late email to the physician groups followed another public rebuke, this one published in The New England Journal of Medicine by the 17 ousted ACIP members. They outlined the layers of review and recommendation with the advisory panel; the U.S. Food and Drug Administration, which authorizes use of medicines; and the U.S. Centers for Disease Control and Prevention, which makes the formal recommendation on who should get the shots.

“The process of recommending vaccines in the United States has undergone a seismic disruption,” they wrote. “The government has abruptly changed vaccine policy through social media postings and publications in news media. These actions circumvented the standard methodology, whereby committees of scientists and clinicians conduct rigorous scientific review and open deliberation to make vaccine recommendations, which are published with clear justification of the decision-making process.”

Three major problems, and damage control

They argue the actions have created three major causes for concern for U.S. vaccine policy: the quality and availability of data; straightforward guidance for physicians, other clinicians and the public; and insurance coverage, along with vaccine access, uptake and equity.

“The nation now faces a scenario in which the rigor and discipline of these vaccine recommendation processes are rapidly eroding,” they said. “In the absence of cohesive national policies, the professional organizations as well as state and local public health officials will need to navigate their own paths forward unless some unified federal leadership, distinct from the CDC and the FDA, emerges.”

The former members recommended the nation needs an alternative to ACIP, possibly independent of the federal government. It is clear HHS “cannot uphold the necessary rigor and infrastructure of the ACIP,” they said.

“No viable pathway exists to fully replace the prior trusted and unbiased ACIP structure and process,” the former ACIP members said. “Instead, the alternatives must focus on limiting the damage to vaccination policy in the United States.”

That article listed the full slate of liaison organizations. There are more than just the physician groups, but it was unclear on Aug. 1 if all will be excluded from future deliberations.

The NEJM article also followed a June editorial in JAMA, in which the former ACIP members said Kennedy’s actions “critically weakened” the nation’s vaccine program.