CDC Advisers Vote to Make COVID Shots a Personal Choice

The Advisory Committee on Immunization Practices (ACIP) — a panel that works on behalf of the Centers for Disease Control and Prevention (CDC) to devise vaccine policy — voted last week against recommending COVID-19 shots.

ACIP urged that more detailed information regarding “risks and uncertainties” of vaccination be added to handouts given to patients before immunizations.

The ACIP also voted to restrict access to a combination childhood vaccine for measles, mumps, rubella, and chicken pox.

Physicians’ Group Continues to Recommend the COVID Vaccine

But national physician organizations continue to recommend the COVID vaccine as safe, effective, and necessary to protect against severe infections that can lead to hospitalization or even death.

The AAFP’s stance aligns with recommendations by the American Academy of Pediatrics advising COVID vaccines for young children ages 6 to 23 months (who are at high risk for severe COVID) and for children ages 2 to 18 who have medical conditions or other issues that increase their risk.

The AAFP position on COVID vaccines also echoes those of the American College of Obstetricians and Gynecologists, which recommends COVID vaccines for pregnant patients during any trimester (and during the lactation period as well) because of their increased risk of severe COVID and because expectant mothers can pass protective antibodies to babies in utero.

Committee Decision Follows New FDA Restrictions on COVID Vaccines

The CDC and the U.S. Food and Drug Administration (FDA) have different roles, and at times their stances differ. That seems to be the case with the COVID-19 vaccine.

The FDA’s role is to determine whether a medical product is safe and effective, and whether its benefits outweigh its risks.

In contrast, the CDC is tasked with providing clinical guidance on how a medical product should be used in the U.S. population. A CDC endorsement or recommendation generally triggers public and private insurance coverage.

In August, the FDA approved the most recent COVID shot for adults 65 and older and people with certain conditions that raise the risk of serious complications from infection. (Doctors can still prescribe the shot “off-label” for individuals who don’t meet those requirements, but access can vary significantly depending on location.)

Then came the ACIP decision. If the CDC director signs off on it, the COVID vaccine will be removed from routine vaccination schedules for eligible patients, leaving individuals to seek it out.

The ACIP echoed the FDA by emphasizing that the risk-benefit of vaccination in people under age 65 is most favorable for those who are at an increased risk for severe COVID and lowest for individuals who are not at an increased risk.

Could the New Recommendations Limit COVID Vaccine Access?

For Peter Chin-Hong, MD, an infectious-disease specialist and a professor of medicine at the University of California San Francisco School of Medicine, many questions remain unanswered about the ACIP stance.

For example, he says, how will the federal government determine whether informed clinical decision making has happened? And, he adds, will patients skip vaccination based on the hoops they have to jump through?

“Usually an ‘informed clinical decision’ means that patients and providers discuss risks and benefits of the vaccine based on individual health status,” says Dr. Chin-Hong. But he estimates that almost a third of Americans don’t have a primary care clinician, so finding a healthcare provider to talk with may be a challenge.

“Many high-risk individuals who would have normally received the vaccine may not do so this year,” he says. “What I worry about most of all is that the people who need immunity reminders — like those over 65, those who are pregnant, and immunocompromised people — may not get their vaccines and that may contribute to additional hospitalizations and death.”

It’s also difficult to know whether the new ACIP guidelines, if endorsed by the CDC, would allow any healthy person who wants a COVID vaccine to get one.

“I think access to the vaccine is going to vary from state to state, and even in some cases from pharmacy to pharmacy,” said Sean O’Leary, MD, the chair of the American Academy of Pediatrics infectious disease committee, at a press conference.

“What we’re seeing is that clinicians and pharmacists are confused. By the rules, I would say that they [healthy individuals] should be able to get vaccinated. What actually happens in reality is hard to say.”

Will Insurance Cover COVID Vaccines?

Some public health officials have expressed concerns that the ACIP vote could restrict coverage through so-called entitlement programs like Medicare and Medicaid for people who meet FDA eligibility requirements.

But HHS maintains that the new guidelines allow for “immunization coverage through all payment mechanisms including entitlement programs.”

Panel Rejects Combo Shot for Measles, Mumps, Rubella, and Chicken Pox for Young Kids

The decision, in effect, eliminates the combined vaccine option for younger children.

Febrile seizures can be scary to watch, but those triggered by vaccines are rare, and they pass quickly with no lasting impact.

A Minority of Children Get a Combined MMRV Shot

He does, however, find the policy shift troubling, because there has been no new data or new safety concerns regarding the combination shot.

“This recommendation potentially increases the uncertainty that people may have about vaccines in general,” says Chin-Hong.