New vaccination recommendation appears to clear way for COVID shots without prescription

A key federal advisory panel on Friday declined to issue a blanket endorsement of coronavirus vaccines but cleared the way for those age 6 months and older to get fall shots without requiring prescriptions — a possibility that many physicians had feared would create turmoil.

Many private health insurance companies had already signaled they intended to cover COVID-19 vaccines at no additional cost even if the federal Advisory Committee on Immunization Practices restricted its formal recommendation to a narrow demographic, such as those age 65 or older or with medical conditions that put them at greater risk of severe illness. That concern followed an initial decision by the U.S. Food and Drug Administration that approved vaccines for those narrow conditions.

There remained some question about how government health programs such as Medicare and Medicaid would handle such a decision. But in a statement issued Friday, shortly after the ACIP concluded the second day of its two-day meeting in Atlanta, the U.S. Department of Health and Human Services said the decision “allows for immunization coverage through all payment mechanisms including entitlement programs such as the Vaccines for Children Program, Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal Health Insurance Marketplace.”

Also, the California Department of Healthcare Services clarified Wednesday that recent legislation requires Medi-Cal, the state’s version of Medicaid for needy residents, to cover COVID and a broader range of vaccinations if they are recommended by the state Department of Public Health, which the agency updated Wednesday to concur with guidance from a new alliance of western states.

The ACIP vote still requires final approval by the director of the U.S. Centers for Disease Control and Prevention, or CDC.

It was the unanimous recommendation of committee members on Friday that COVID vaccination should be “based on individual-based decision-making.” That is significantly less forceful than the blanket “general” endorsement that all previous versions of the COVID vaccine have received.

A general recommendation confidently says that the benefit of vaccination so heavily outweighs the risks that everyone should receive it; an individual decision-making decision suggests that the cost-benefit analysis is closer to 50/50.

Some new ACIP members are longtime vaccine skeptics, as is Health and Human Services Secretary Robert F. Kennedy Jr., who appointed them. Several had said they are not satisfied with the level of medical evidence used to approve COVID vaccines, especially for children and pregnant women. Experts who regularly advise the committee, and representatives from powerful organizations such as the American Medical Association, pushed back hard against such statements.

But the panel decided to go with recommendations that urge individual Americans to consider “that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk.”

There was some confusion about whether the recommendation approved Friday sought to require those seeking COVID vaccination to have conversations with medical professionals about the risks and benefits involved before rolling up their sleeves.

Even though the less-forceful vaccine recommendation seems to suggest that individuals seek out a conversation with a medical professional in order to assess such risk, there does not appear to be any hard-and-fast requirement that they do so in order to be vaccinated. The language presented to committee members does not explicitly say that any such consultation is required, nor does the subsequent statement issued by the Department of Health and Human Services.

An attempt to require vaccine prescriptions failed on a split vote, with many committee members saying that sending so many to their doctors to get approval to receive a vaccine could inundate already overwhelmed medical facilities nationwide, especially if it invalidated the ability of pharmacists to give such advice.

A day earlier, the committee acted to change recommendations for young children, indicating that a risk of seizures necessitated separate chickenpox vaccinations through age 3. Previous recommendations, widely supported by pediatric experts, called for the use of a vaccine that addressed four different illnesses, measles, mumps, rubella and chickenpox. The change was immediately criticized, with experts saying it was not based on sound science.

The specifics of ACIP’s COVID vaccine recommendation likely would have been moot in California, as the state announced this month it banded together with Oregon and Washington to create a “West Coast Health Alliance” that will begin making “evidence based unified recommendations to their residents regarding who should receive immunizations and to help ensure the public has access and credible information for confidence in vaccine safety and efficacy.”

The move follows statements from more than 70 professional medical organizations nationwide that have endorsed continuing broad-based vaccination recommendations, with the professional organizations representing health insurance companies saying they intended to follow such guidance if the CDC narrowed its scope.

As the respiratory virus season arrives, some still worry that so many statements and counter-statements about vaccines will ultimately create a chilling effect. Many have significant reservations about the safety and efficacy of the COVID vaccine, despite assurances from most experts that the benefits outweigh the risks.

Dr. Anil Keswani, chief medical and operations officer of ambulatory care at Scripps Health in San Diego, said many patients, and even medical professionals, have become confused in recent months as so much attention was paid to the possibility that updated booster shots might not be approved in time for use in the fall or that specific groups of people, especially those younger than age 65 with no health problems, would not be able to get them without paying out-of-pocket.

“There has just been so much noise, and people are like ‘what’s the signal?’” Keswani said.

The task before clinicians, he added, is to work one-on-one with patients to clear away confusion.

“What’s challenging for the front-line doctors and patients is, you know, trying to sift through that confusion that has built up,” Keswani said. “When you want to provide advice, you want to try to make that advice as simple as possible.

“What we really want is to let physicians get the science, understand the science, and from that place, shared medical decision making with patients is really medicine 101.”