HARRISBURG — Pharmacies in Pennsylvania are now able to offer COVID-19 vaccines, but that doesn’t mean everyone who wants a shot will be able to get one at these health care stores.
At the behest of Gov. Josh Shapiro's administration, the State Board of Pharmacy gave pharmacists the OK to administer immunizations for the virus based on guidelines from additional “competent authorities,” including the federal Food and Drug Administration and major medical associations.
However, these guidelines provide different levels of access, and experts say it’s now up to pharmacies to decide which recommendations to follow.
Under the Trump administration, the FDA has narrowed eligibility to adults over 64 and others with underlying health conditions. It previously said anyone over 6 months was eligible, guidance that groups like the American Academy of Family Physicians are still embracing.
Here’s what you need to know about the vote, who can get a shot, and more:
What’s the issue?
In Pennsylvania, state law ties the ability of pharmacists to provide vaccines to recommendations from the federal Advisory Committee on Immunization Practices (ACIP).
That’s become a problem in recent months.
ACIP “develops recommendations on how to use vaccines to control disease in the United States,” according to the CDC. Those recommendations became official policy once adopted by the director of the CDC.
Health and Human Services Secretary Robert F. Kennedy Jr. removed all members of ACIP in early June, and the committee has not voted on COVID-19 vaccine recommendations for this fall, when the flu and respiratory illnesses tend to increase.
The lack of approval led Pennsylvania pharmacies to not offer COVID-19 vaccines, according to the Shapiro administration and pharmacists who spoke with Spotlight PA.
“We were stuck in Pennsylvania,” said Rick Seipp, president of Value Drug Company and an official with the Pennsylvania Pharmacists Association.
The FDA in August approved updated COVID-19 shots but narrowed their use, creating barriers to people without certain underlying health conditions under 65. CBS News later reported that CVS and Walgreens, major pharmacy chains in Pennsylvania, were requiring a prescription for COVID-19 vaccines or not offering them in some states.
Medical professionals worry many people won’t be able to access COVID-19 vaccines as the fall approaches.
What agency is in charge of approving vaccines?
The FDA approves vaccines across the country.
In Pennsylvania, the State Board of Pharmacy has certain authority over how patients access the shots. State regulations allow pharmacists to administer vaccines if doing so aligns 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 Board.”
(In addition to the lack of ACIP guidance, the CDC also rolled back guidelines that recommended the COVID-19 vaccine for healthy children and pregnant women.)
The power to approve another “competent authority” has put the board at the center of a broader fight over vaccine access in Pennsylvania.
What did Gov. Josh Shapiro ask the State Board of Pharmacy to do?
Shapiro says he called “on the State Board of Pharmacy to hold a special meeting to bring clarity to the people of Pennsylvania.”
“Health care decisions should be up to individuals — not the federal government and certainly not RFK Jr.,” he said in a news release. “My Administration will continue to protect health care access for all Pennsylvanians.”
The board held the special meeting to address the issue on Sept. 3.
What did the board do? And what does it mean?
The State Board of Pharmacy designated three professional medical societies — the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists — as “competent authorities” for vaccine treatment guidelines, according to the agenda of the special meeting. It also added the FDA as a “competent authority” specifically for COVID-19 vaccines.
All have already endorsed the use of COVID-19 vaccines under various circumstances, but their guidance differs.
After the meeting, the Shapiro administration described all four as “newly approved sources of authority.”
Susan Kressly, president of the American Academy of Pediatrics, has already clashed with Kennedy over vaccines. Kressly criticized Kennedy’s actions, saying that “proposing to limit the availability of COVID-19 vaccines for children and young adults is deeply troubling.” Kennedy — a noted vaccine skeptic — has said he wants “to keep vaccines available to people who want them, especially the vulnerable.”
The Board of Pharmacy’s action will make it easier for patients to access vaccines, according to lawmakers and industry experts.
“We don’t want to be put into a position of saying, ‘Oh, we can’t because the governing authorities won’t let us,” said Rob Frankil, executive director of the Philadelphia Association of Retail Druggists. “We want it to be patient-driven. We promote good health.”
Who can get a shot? And where?
That’s still an open question.
The Shapiro administration has said people who want a COVID-19 vaccine should contact their pharmacy before scheduling an appointment to ensure availability.
Pharmacist Eric Pusey, who owns a practice in Lackawanna County, ordered COVID-19 vaccines and is waiting for them to arrive. He told Spotlight PA that even with the Board of Pharmacy’s action, he believes access to COVID-19 vaccines without a prescription will be more restricted, due to federal changes.
He is working to update his consent forms to ensure they comply with various federal, state, and insurance requirements. He’s pleased with the Board of Pharmacy's action, but said the situation is still “confusing” and “complex,” and that it will be “potentially difficult for most of our patients to understand where they stand with their COVID vaccines.”
Brittany Radomski, an Allegheny County pharmacist, also praised the board’s actions. She said there are questions remaining about implementing the changes, and hopes any delays will be resolved with updated protocols and guidance.
It takes time to get everyone on the same page, she noted. “I’m telling people to just stay calm.”
Eric’s RX Shoppe in Montgomery County posted a detailed FAQ on its website that shows how it is navigating the uncertainty. The pharmacy is following guidance from the FDA to decide who it can provide the vaccine to.
“There’s a lot of things that are up in the air,” co-owner Marc Ost told Spotlight PA.
For a new COVID-19 vaccine, patients have to meet one of two conditions, according to the pharmacy’s FAQ. They must be 65 or older, or be between 12 and 64 and have at least one underlying medical condition that places them at higher risk for severe COVID-19 outcomes. There are a variety of such conditions, including asthma, cancer, smoking, and obesity.
For now, patients who don’t meet those age and health criteria need a prescription to receive a vaccine from Eric’s RX Shoppe. “This policy may change as we receive further guidance from our regulatory bodies,” the FAQ says.
For children ages 3 to 11, the FAQ says Eric’s RX Shoppe anticipates shipments of the pediatric COVID-19 vaccine from Moderna to arrive around the middle of September.
Officials with CVS, which was mentioned in the Shapiro administration news release, have said they will ensure COVID-19 vaccines “are available as soon as possible.”
When scheduling an appointment or completing a health screening form, CVS patients seeking a COVID-19 vaccine “are asked to attest to their eligibility,” based on FDA and CDC guidelines, according to spokesperson Amy Thibault.
Thibault said the only vaccines impacted by the Board of Pharmacy’s actions were the updated COVID-19 vaccines, as they have not been recommended by ACIP and authorized by the CDC.
“We are able to administer all other vaccinations we offer,” including the flu shot, Thibault said.
Does this decision mean my insurance will cover it?
Insurance companies can generally decide what’s covered, but approval by government agencies can influence those policies, said Frankil of the Philadelphia Association of Retail Druggists.
“If the state and certain governing bodies say it’s OK, in general, the insurance companies will cover it,” he said. “But if they say it’s not OK, then that gives the insurance companies an out for not covering a vaccine.”
Thibault, the CVS spokesperson, said: “Our understanding is that the COVID-19 vaccine is covered by most insurance plans at no cost for eligible patients. Patients should check with their insurer to determine whether the updated COVID-19 vaccine is covered by their individual health plan.”
Multiple pharmacists told Spotlight PA the insurance question concerns them. Some were more optimistic than others. The FAQ from Eric’s RX Shoppe says the cost of the vaccine is covered by Medicare Part B, a medical insurance plan for older adults.
“Based off conversations we have had,” the guide says, “we are confident that other insurers will continue to provide coverage for the COVID-19 vaccines through this respiratory season.”
What legislative action is being considered?
Democrats in the state House and Senate have floated a few proposals related to expanding vaccine access.
State Rep. Arvind Venkat (D., Allegheny), a practicing emergency physician, has introduced a bill that would mandate commercial insurers cover vaccines approved by the FDA and recommended by certain professional medical organizations. A companion bill was introduced in the state Senate by Maria Collett (D., Montgomery).
A second bill Venkat plans to introduce would clarify how pharmacies should handle differing vaccination recommendations from “competent authorities.”
For example, Venkat said that he could qualify for receiving the COVID-19 vaccine under the guidelines from the American Academy of Family Physicians, but not qualify under the FDA’s recommendations.
“The question that I have, and it's a question that needs to be posed to the pharmacist, to CVS, and others, is if the recommendations are not the same, then who are you following when someone walks in?” Venkat said.
Venkat said a variety of agencies could take the lead in that process, such as the state Department of Health.
“What happened … with the State Board of Pharmacy was an outstanding first step,” Venkat told Spotlight PA. “But because of the chaos at the federal level and the differing recommendations that are out there, we need more definitive state action to provide clarity.”