SPOTLIGHT PA: The Broader Covid Vaccine Recommendations Embraced By PA and How They Conflict With Federal Guidelines

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HARRISBURG — Pennsylvania pharmacies and their patients are navigating competing guidelines for who can receive COVID-19 vaccines despite the shots being available.

The FDA in August approved updated vaccines for a more limited group than in the past, authorizing them for adults over 64 years old and people with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

But recommendations from some leading medical groups go further. The American Academy of Family Physicians, as one example, recommends them for adults 19 years and older, even for people not at high risk of complications if they catch COVID-19.

Pennsylvania’s situation is part of the ongoing conflict around vaccines across the country, which some providers and medical professionals fear will increase confusion and lower vaccination rates this year.

“I’m very concerned about the noise in the system,” Mitchel Rothholz, a member of the Pennsylvania Pharmacists Association told Spotlight PA, “and its impact on the confidence of the public and providers to do vaccinations.”

The guide below will help you make sense of the different recommendations and treatment guidelines in Pennsylvania. The State Board of Pharmacy recently stepped into the debate by giving pharmacists more options for whose recommendations to follow.

However, despite the board’s recent action, a review by Spotlight PA in mid-September found several big chains in the state citing or relying on the FDA’s more restrictive COVID-19 guidance for eligibility.

Why are pharmacies so important for vaccines?

Many patients go to their local pharmacy to receive annual flu and COVID-19 shots.

In Pennsylvania, pharmacies that provide vaccines typically have protocols in coordination with a physician that outline the criteria for administering vaccines and who’s eligible, pharmacists and industry experts told Spotlight PA. Those protocols mean that each patient does not need an individual prescription for a vaccine.

State regulations outline which treatment guidelines pharmacies should follow: A pharmacist or pharmacy intern should administer vaccines “in accordance with treatment guidelines established by a physician and the Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices Guidelines or another competent authority approved by the [State Board of Pharmacy],” per the regulations.

In early September, amid concerns about federal changes to COVID-19 vaccine eligibility, the State Board of Pharmacy newly approved the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and the American Academy of Family Physicians as competent authorities. The board also approved the FDA as a competent authority specifically for COVID-19 vaccines.

Victoria Elliott, CEO of the Pennsylvania Pharmacists Association, told Spotlight PA in mid-September that she hadn’t seen the specifics on which treatment guidelines pharmacies are following.

“My guess is they’re incorporating everything to give them … the ability on a case-by-case basis just to make decisions,” she said.

Rob Frankil, executive director of the Philadelphia Association of Retail Druggists, expects pharmacies to use the medical associations’ guidelines, which cover more people than the FDA’s approval.

Other states have taken similar action to allow access to COVID-19 vaccines.

Margot Savoy, chief medical officer for the American Academy of Family Physicians, welcomed the state pharmacy board using her organization as a resource. But she wishes the process of vaccinating the public was simpler for patients and clinicians alike.

“I’m disappointed that we can’t have a single, unified set of guidance for clinicians to use and for patients to have and understand that comes from a federal authority that we could all trust and rely on,” she told Spotlight PA.

“I don’t like that you have to go state by state to make sure that people have access to the things they need,” Savoy added, “which feels dangerous because it’s something that’s time sensitive.”

Respiratory virus illnesses, including RSV, COVID-19, and the flu, and hospitalizations from them tend to increase in the fall and winter.

What are the federal recommendations for COVID-19 vaccines?

Previous federal guidance recommended COVID-19 vaccines for everyone 6 months and older. But in August, the FDA narrowed its approval.

People 65 and older remain eligible under the FDA’s change. But people ages 6 months through 64 years should have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, the agency said.

In a medical journal article ahead of the decision, FDA officials said the value of booster shots is “uncertain,” and said the new policy “balances the need for evidence.”

Later, the CDC’s Advisory Committee on Immunization Practices did not recommend COVID-19 vaccines for everyone 6 months and older, as it had in the past. Instead, the committee’s recommendations left the decision up to individuals and their health care provider.

Physicians, nurses, and pharmacists are among the providers people seeking a COVID shot can consult with, according to a U.S. Department of Health and Human Services news release.

Some medical professionals are concerned about the committee’s votes and comments its members have made about vaccines. The American Academy of Family Physicians said the committee’s “votes on COVID-19 vaccine recommendations will create confusion and real consequences for patients’ trust.”

If the CDC director or acting director adopts the committee’s recommendations, they become part of the agency’s immunization schedule, according to the U.S. Department of Health and Human Services’ news release and a department spokesperson.

What conditions put people at higher risk?

There are many, according to a CDC list that was cited by FDA officials.

It includes asthma, cancer, depression, heart conditions, obesity, physical inactivity, and pregnancy and recent pregnancy. “Smoking, current and former” is also on the list. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,” FDA officials said.

Rothholz, the Pennsylvania Pharmacists Association member and a former senior staffer with the American Pharmacists Association, told Spotlight PA that the CDC’s list is “very broad.”

“There’s enough in that list that … most patients could fit in there,” he said.

Still, the FDA approvals leave people out. The recommendations from medical associations that were approved by the State Board of Pharmacy include more people.

What do medical groups recommend for children?

The American Academy of Pediatrics recommends all infants and children from 6 months through 23 months of age receive a version of this season’s COVID-19 vaccine. The guide notes an exception for children with a condition that makes the vaccine inadvisable or potentially harmful, such as a history of severe allergic reaction after a previous dose or to a component of the vaccine. (Guidelines from other medical organizations include similar screening and precautionary notes to their general recommendations for various groups.)

The group also recommends a COVID-19 vaccine for children from 2 through 18 years of age if they are considered in certain risk groups. Those groups are listed as: at high risk of severe COVID-19; a resident of a long-term care facility or other congregate setting; have never been vaccinated against COVID-19; or have household contacts who are at high risk for severe COVID-19.

Even if 2- through 18-year-olds are not in one of those risk groups, the American Academy of Pediatrics says they “should be offered a single dose” of an age-appropriate COVID-19 vaccine for this season if their “parent or guardian desires their protection from COVID-19.”

The American Academy of Family Physicians has offered similar guidance for vaccines for children and adolescents.

What about adults?

The American Academy of Family Physicians recommends a COVID-19 vaccine for adults 19 years and older, and the group says the vaccines are especially important for adults 65 years and older, people at increased risk for severe COVID-19 infection, and people who have never received a COVID-19 vaccine.

Savoy, chief medical officer for the American Academy of Family Physicians, said its officials considered changing the recommendations so that it would be based on risk factors for adults.

“The challenge is that if you look at who falls into the high risk group for adults, it would be really hard to find enough people who weren’t either in that high risk group or living in close contact with someone in the high risk group,” Savoy told Spotlight PA.

“So why make it more complicated than it needs to be?” she added.

The group kept a universal recommendation for adults.

Pregnant people?

Earlier this year, Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC removed a recommendation for healthy children and healthy pregnant women to receive a COVID-19 vaccine. Kennedy called the change “common sense” and “good science.”

Kennedy has a long history of skepticism and criticism of vaccines. The headline of a 2023 Associated Press article said he “spent years stoking fear and mistrust of vaccines.” Kennedy has said he’s “pro-safety” and not “anti-vaccine.”

His announcement of the recommendation change for children and pregnant women led to ongoing conflict and litigation.

The American College of Obstetricians and Gynecologists continues to recommend an updated COVID-19 vaccine or booster for anyone who is pregnant or lactating.

“Pregnant women have historically been at an increased risk of severe disease, adverse pregnancy outcomes, and maternal death from COVID-19 infections,” the group says.

The American Academy of Family Physicians offers similar advice.

The American Academy of Pediatrics recommends COVID-19 vaccination for pregnant adolescents. The organization is part of a federal lawsuit against Kennedy, the FDA, and others over the issue of recommendations for healthy children and healthy pregnant women.

“Unless the Secretary’s baseless and uninformed policy decision is vacated, pregnant women, their unborn children, and, in fact, all children remain at grave and immediate risk of contracting a preventable disease,” the lawsuit says.

The case is pending.

Further complicating the issue is the fact that the CDC’s list of risk factors for getting very sick with COVID-19 includes pregnancy.

65 and older?

The FDA in August approved COVID-19 vaccines for adults 65 and older, and the CDC website says older “adults are at highest risk of getting very sick from COVID-19. More than 81% of COVID-19 deaths occur in people over age 65.”

The American Academy of Family Physicians says adults 65 and older should receive two or more doses of a COVID-19 vaccine.

What about flu shots?

Flu and COVID-19 shots are frequently offered at the same time, but the flu jabs haven’t been subject to the same uncertainty as those for COVID-19.

The federal Advisory Committee on Immunization Practices earlier this year recommended an annual flu vaccine for everyone 6 months and older, as long as they don’t have a condition that would make such vaccines inadvisable or potentially harmful. It’s a similar recommendation to prior years.

What are Pennsylvania pharmacists doing?

The Pennsylvania Pharmacists Association has provided COVID-19 resources.

Among the advice, the association recommends that pharmacies “update intake forms to include questions about pregnancy, lactation, and whether patients under 65 have conditions that warrant vaccination.”

Elliott, CEO of the association, told Spotlight PA it’s important to gather “that information before you advise whether or not you’re going to administer that vaccine.”

The group also recommends pharmacies verify that insurance will cover the COVID-19 vaccines before billing and collaborate with a supervising physician to update protocols for administering vaccines.

“We’ve advised our members: Get your protocol with your prescribing physician updated to match whatever you agree on,” she said. “There’s this … broad sort of list now of competent authorities, and so you need to get into agreement on what you’re going to follow.”

Frankil’s advice for patients is to check with your pharmacy first.

“And if your pharmacy isn’t doing it, call another pharmacy,” he said. “Just know before you walk in.”

The Pennsylvania Department of Health recently issued guidance encouraging people to follow the most recent immunization recommendations from the three medical associations approved by the State Board of Pharmacy.

What about the big chains?

In mid-September — ahead of votes by the Advisory Committee on Immunization Practices — Spotlight PA reached out to some of the top chains in Pennsylvania and reviewed their websites.

Spokespeople or websites for Walgreens, GIANT, Giant Eagle, CVS, and Weis Markets referred to the FDA approvals and guidance for COVID-19 vaccines — not the recommendations from the three medical associations that Pennsylvania’s Board of Pharmacy recently approved.

“We continue to monitor this fluid situation,” Dennis Curtin, a Weis Markets spokesperson, told Spotlight PA.

An FAQ on COVID-19 vaccines from Walmart also offered guidance that’s in line with the FDA’s approvals, recommending them for patients “65 years and older and patients 6 months through 64 years of age at risk of severe COVID-19 disease.”

Will insurance pay for it?

An FAQ from Walgreens said many private insurers and government programs “may still cover the costs of COVID-19 vaccines for their members.” A similar FAQ from CVS said the “COVID-19 vaccine is available at no cost through most insurance plans” and recommended patients check with their insurance provider for confirmation.

Ahead of a recent meeting of the CDC’s Advisory Committee on Immunization Practices, top officials in Democratic Gov. Josh Shapiro’s administration warned that actions to pull back on recommendations could cause a “lack of insurance coverage, limited provider availability, and patient and provider confusion.” A U.S. Department of Health and Human Services news release later said the approach the committee recommended “allows for immunization coverage through all payment mechanisms,” including insurance plans.

In a new release after the committee votes, the Shapiro administration said the Pennsylvania Insurance Department is “working with health insurers across the Commonwealth to ensure that all previously recommended vaccines continue to be covered.”

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