Pennsylvania allows leading medical societies to guide vaccine access as new federal restrictions create confusion

Amid new restrictions and delays around COVID vaccine distribution, Pennsylvania’s regulatory body for pharmacists on Wednesday expanded the authority to make vaccine recommendations to several leading professional medical organizations.

The move allows state pharmacies to begin administering the latest COVID vaccines, whose distribution had been in a holding pattern creating confusion for patients and pharmacists alike.

Many other states, including New Jersey, permit pharmacies to distribute vaccines without the approval of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

But under Pennsylvania law, pharmacies can only give out vaccines in accordance with “treatment guidelines” from a physician and ACIP. The state Board of Pharmacy can also designate another “competent authority” to provide treatment guidelines.

In a year of chaos at the CDC, the agency has not released its recommendations yet. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, fired all members of ACIP earlier this year and replaced them with a handpicked group that included vaccine skeptics.

Former CDC director Susan Monarez was forced out last week, in part for reportedly refusing to rubber-stamp vaccine recommendations from the reconstituted ACIP.

And the FDA, in an unusual move, approved last week COVID vaccines only for older Americans and certain at-risk groups. Typically, the agency issues a general approval for the vaccines and allows ACIP to recommend which groups should receive it.

ACIP usually issues its recommendations immediately after the FDA approves a vaccine. But this year, the committee is not meeting until Sept. 18, creating delays in vaccine distribution in Pennsylvania.

Gov. Josh Shapiro called the FDA’s restrictions on COVID vaccines “outrageous” and “an affront to Pennsylvanians’ personal freedoms,” noting that he had pushed for a special meeting of the Pennsylvania Board of Pharmacy to resolve the situation.

“Healthcare decisions should be up to individuals — not the federal government and certainly not RFK Jr.," he said in a statement. “My Administration will continue to protect healthcare access for all Pennsylvanians.”

On Wednesday, health officials, professional medical organizations, and pharmacists described to the board the impact of the shake-ups at federal health agencies and the necessity of administering COVID vaccines as soon as possible.

Robert Bonacci, a special adviser to the state’s secretary of health, suggested the pharmacy board look to professional medical organizations for vaccine recommendations in light of the changes at the CDC.

“It’s left many concerned about the integrity of the [vaccine] review process and the trustworthiness of those recommendations,” he said.

The board’s decision came as West Coast states said they would offer their own vaccine guidelines to residents, while Northeastern states, including Pennsylvania, had reportedly met to consider forming a similar consortium, the New York Times reported. Meanwhile, Florida officials are proposing to end all vaccine mandates, including those for schools, the Times reported.

Wednesday’s move should allow Pennsylvania pharmacists to begin administering the vaccine to some patients in a newly complicated regulatory environment around vaccines.

The Pennsylvania Board of Pharmacy approved the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) as “competent authorities” for vaccine recommendations.

The FDA was also approved as a “competent authority” specifically for COVID-19 vaccine recommendations.

Recommendations for COVID vaccines differ between the professional organizations and the federal agencies. For example, healthy children are recommended to receive the updated vaccines in some of the guidance from the leading medical societies, but are not included in the FDA’s more restrictive licensing.

A source with knowledge of the board’s decision said that pharmacists can now choose which agency or organization’s recommendations they wish to follow.

“Before today’s Board vote, Pennsylvania pharmacists could follow only ACIP’s vaccine recommendations. Today’s vote changes that, allowing Pennsylvania pharmacists to follow the vaccine recommendations of other trusted authorities restoring access and cutting through the confusion,” Shapiro’s administration wrote in a statement.

The situation has also been difficult for pharmacists to navigate, said Mayank Amin, who runs the independent Skippack Pharmacy in Montgomery County, where he expected to receive this year’s first vaccine shipment Wednesday.

About 2,000 people had already signed up to receive updates on the vaccine from his pharmacy, he told the pharmacy board in written testimony.

“We need your support to help our fellow Pennsylvanians who wish to be vaccinated,” he wrote. Amin said Wednesday he plans to follow the FDA’s recommendations for handing out vaccines and would start vaccinating that day.

Stanley Jaskiewicz, 65, of Lansdale, qualifies for the vaccine under FDA guidelines because of his age and because he has a heart condition that could result in life-threatening complications if he contracts COVID.

But before the Board of Pharmacy’s decision, he was finding it difficult to parse the new rules around COVID vaccines.

Jaskiewicz’s doctor had offered to write him a prescription for the vaccine — as CVS had been requiring in Pennsylvania — but when he attempted to schedule a vaccine appointment online last week, a screen popped up saying that no appointments were available.

“It feels like 2020 all over again,” Jaskiewicz said on Tuesday. “It’s just very frustrating. People who truly need to have this protection have to jump through hoops.”

He was able to schedule an appointment at an independent pharmacy on Wednesday, he said.

Before the Board of Pharmacy met on Wednesday, CVS was requiring that Pennsylvania patients get a doctor’s prescription before obtaining a vaccine at an in-store pharmacy.

Another option was to schedule an appointment at a Minute Clinic, CVS’ urgent care clinics, which are classified as doctors’ offices, not pharmacies. A prescription is not required to receive a vaccine from Minute Clinics, CVS spokesperson Amy Thibault said on Tuesday.

Patients in Pennsylvania who live near the New Jersey border could also consider getting vaccinated there, she said.

When Lynn Hogben, 70, called to schedule a shot last week, her local CVS in West Philadelphia told her that its pharmacy was not stocking COVID vaccines at all.

“This is appalling, because some people’s lives are going to be put in jeopardy,” Hogben said. “There are people in much more serious shape than I, and those people are potentially being denied vaccines.”

Thibault said that the store employee in West Philadelphia may have been uncertain about the vaccine’s availability, or the store may not have had the vaccine in stock yet.

She did not immediately return a request for comment on the Pennsylvania Board of Pharmacy’s decision.