Physicians say ACIP must consider their real-world experience with patients, along with science

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Physicians say the Advisory Committee on Immunization Practices (ACIP) must consider their experiences treating patients in examination rooms and clinics across the country.

Doctors were among the speakers weighing in on ACIP deliberations on Sept. 18, the start of the two-day meeting. Everyone involved maintained decorum and the meeting did not devolve to any fist-pounding or shouting matches. But it had numerous question-and-answer dialogues with the voting members, liaison organizations representatives and various staff presenters.

The morning session included presentations and discussion about the measles-mumps-rubella-varicella (MMRV) vaccine and how it was different from the separate MMR and varicella shots, or MMR+V. The separate vaccines generally cause fewer harmful or adverse events, such as febrile seizures, which the ACIP members agreed can create serious health issues for babies, along with emotional distress for their families.

Information on hepatitis B vaccines followed in the afternoon. The staff presentations included pages of data, and member questions and deliberations could span several hours.

ACIP members brought a few personal points to the discussions. Chair Martin Kulldorff, PhD, said when his twin children were vaccinated, he asked if it was the MMR+V, or the separate shots. Without knowing his background, he said the nurse gave him a correct explanation that they would get separate shots. That is the case for approximately 85% of the infants receiving the shots.

Removing an option for parents?

As the members began considering the draft wording about changing the recommendation for the MMRV vaccines, ACIP member Cody Meissner, MD, pointed out variables for the MMRV vaccine based on patient age and whether young families may be traveling to an area where they could be exposed to measles.

He also noted changing the recommendation against the MMRV vaccine could take an option away from parents, even though most parents opt for multidose vaccine.

“What we're saying is, we don't trust parents to make a decision,” Meissner said. “Some parents don't want to administer two doses of a vaccine if they can receive one and get the same degree of coverage.”

Meissner said he prefers that families have the option to make a selection, and if ACIP changes the recommendation, that won't be an option.

“We know that most are getting, as we said, 85% are getting the two doses,” Meissner said. “But if a parent wants to get a single dose, why are we taking away that that option?”

Physicians want evidence

Jason M. Goldman, MD, MACP
_{© American College of Physicians}

American College of Physicians President Jason Goldman, MD, MACP, also commented on the draft recommendation.

“I will reiterate the question I asked at the last meeting: Are we going to have a thoroughly vetted, evidence to recommend framework presentation that looks at all the harms, benefits, acceptability, feasibility, with input from practicing clinicians and liaisons, in order to make an informed decision?” Goldman said.

“I would argue that this recommendation is going to create more confusion among the public,” he said. “It does not involve the aspect of actual practicing clinicians and how we deal with vaccine hesitancy and how we talk to our patients.

“And also, when you make this recommendation, you now give license to insurance companies and the Vaccines for Children program not to cover this vaccine,” Goldman said. “And finally, you are taking away the choice of parents to have informed consent and discussion with their physician on what they want to do for the health and benefit of their children.

“So I urge this committee not to change the recommendations, if they truly want to give power to the parents to decide what is best for their child and allow them to make the choice in consultation with their physicians,” he said. “And if we are going to have these recommendations, I urge the committee to go back to the very well-done evidence to recommend framework that we have been using for years to make sure all data is done transparently so we can have that debate and discussion that you requested at the beginning.”

What does the evidence show?

Goldman had agreement from Robert H. Hopkins, Jr., MD, medical director of the National Foundation for Infectious Diseases, and Amy Middleman, MD, MPH, MSED, FSAHM, representing the Society for Adolescent Health and Medicine.

“It is critically important that we present all available evidence to make these decisions in one coherent, scientifically vetted presentation, presentation, so that all providers and patients can understand the full breadth of information,” Middleman said. “It's so important to talk about what the evidence shows versus what people may believe that is not necessarily supported by the evidence.”

What’s needed: ‘real-world experience with patients’

Kulldorff praised the presentations as “very excellent and informative.” ACIP member Retsef Levi, PhD, asked the physicians to articulate what information was missing, not discussed or not considered, and Goldman elaborated.

“Well, if I may, it's more than just the data considered. It's also the clinical experience, the work groups, all the liaisons have been removed from the work groups, you do not have those subject matter experts with the real-world experience to understand the implementation of these vaccines and the concerns of the patients,” Goldman said. “You don't have the voice of the patients we take care for. You're not looking at all of the aspects of how we evaluate vaccine implementation.

“You're looking at very small data points and misrepresenting how it works in the real world and how we take care of our patients,” he said. “So no, this was not a thoroughly vetted discussion. I want to see how we implement it, how it's accepted by the population. What's the feasibility, what's the equity? What are the harms and benefits? You have not considered all of those aspects in this presentation. There's something to be said about physicians’ real-world experience with their patients.”

Need more data?

Middleman said she would echo those comments. “And we really need to see all of the data together with the with the vast breadth of scientific data that does not just include the few studies that were presented here,” she said.

Kulldorff replied: “I just have to respond to that, that I trust the CDC staff, that they brought all the relevant data to the question. I am sure we can trust them. And I also look and some of my colleagues, and I think that some of them are pediatric doctors and have experience in caring for patients, but if you will be able to articulate missing data, I think all of us will appreciate hearing about this.”

Hopkins then followed up.

“I certainly appreciate the data that was presented by our CDC colleagues as being thorough and informative, but we have not considered issues around equity,” Hopkins said. “We have not considered issues around the implications of these decisions for our patients and for the practicing physicians who are carrying out these actions. Those missing elements, and going through the full evidence to recommendations framework does not provide us a full opportunity to review all of those elements.”

“Dr. Hopkins said it perfectly,” Goldman said.