COVID Vaccine Guidance Gets More Confusing After CDC Panel. Here’s What We Know

Advisors to the Centers for Disease Control and Prevention (CDC) voted unanimously on Sep. 19 to recommend that people who want a COVID-19 vaccine must consult with a healthcare provider, a process called “shared clinical decision-making.”

The advisory panel voted down an initial proposal to require a prescription for COVID vaccines. However, the meeting seemed to have added more confusion about who could get the shot and how.

Who Is Eligible for a COVID Vaccine?

In August, the Food and Drug Administration (FDA) approved this year’s updated COVID vaccines only for people aged 65 years or older or those with a qualifying health condition.

In its September meeting, the CDC panel, called the Advisory Committee on Immunization Practices (ACIP), didn’t vote to restrict eligibility further. The panel had considered requiring prescriptions to access the COVID vaccines, but ultimately decided against it.

The committee unanimously recommended that all people older than 6 months discuss the risks and benefits of the vaccine with their healthcare providers before deciding whether to get the shot. During the discussion, healthcare providers should emphasize that vaccination is “most favorable” for those at the highest risk of severe disease, the panel said.

Under shared clinical decision-making, some providers might wait until their patient asks for the vaccine, rather than offering it as they would a routine immunization. This may make it more difficult for people with less access to health care and lower health literacy to get the shot.

Pharmacists administer the majority of COVID vaccines, and it’s still unclear whether they will be expected to outline those risks to patients.

“It’s alarming to me that for a primary preventive strategy, we are actually adding access concerns and barriers rather than diminishing them. I think that this is a really important piece of improving public trust in vaccines,” said Amy Middleman, a pediatric physician who spoke as a liaison for the Society for Adolescent Health and Medicine.

The recommendations aren’t final until acting CDC Director Jim O’Neill signs off.

What Is a Qualifying Health Condition for COVID vaccination?

There are dozens of health conditions that make someone eligible for this year’s COVID vaccine, according to the CDC.1 Those include:

  • Asthma
  • Type 1 and 2 diabetes
  • Heart conditions
  • Obesity

How Much Will It Cost?

Health insurance companies look to ACIP recommendations to determine which vaccines to cover.

The committee essentially endorsed the vaccines for people who are eligible under the new FDA licensure. The Department of Health and Human Services (HHS) said in a statement that the vaccine will be covered under government health plans, including Medicaid, Medicare, and the Children’s Health Insurance Program.

Before the meeting, a major health insurance company trade group said providers would continue to cover the cost of COVID vaccines for patients through the end of the year, regardless of what ACIP decided.

Concerns About the Vaccine Panel’s Integrity

The 2024-2025 vaccine reduced COVID-related medical visits, according to data shared by the CDC at the meeting. The risks for COVID-related hospitalizations and deaths remain the highest among older adults and young babies.

A major focus of the panelists was to identify COVID vaccine-related risks to help inform discussions between patients and providers.

Panelist Restef Levi, an MIT professor of operations management, outlined six safety risks and uncertainties to be added to COVID vaccine information sheets. CDC already provides an information sheet on the vaccine,2 but Levi clarified that content would be added. The panel approved the vote.

Several clinicians raised concerns about how the panel presented and discussed data. ACIP has long relied on a framework called the “evidence to recommendations,” which lays out data on the risks, benefits, economic costs, and health equity considerations for interventions like vaccines. The panel, which was hand-picked by Health Secretary Robert F. Kennedy Jr., has thrown that framework out and skipped discussions about race, economic disparity, and healthcare accessibility.

“It’s troubling to see the erosion of the committee’s integrity,” said Sandra Fryhofer, who spoke to ACIP on behalf of the American Medical Association. “We’re concerned about how vaccine recommendations are being developed by this new panel. Data is being selectively used to justify specific conclusions.” 

 

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