COVID Vaccines Are Harder to Get, Despite Claims from HHS, RFK Jr.

Heated exchanges betwixt immoderate senators and Health and Human Services Secretary Robert F. Kennedy Jr. during a Sept. 4 proceeding amplified disorder astir the availability of COVID-19 vaccinations for the fall, with Kennedy misleadingly claiming that “anybody” tin inactive get a vaccine. HHS policies person created roadblocks to vaccine access.

The afloat grade of vaccine availability won’t beryllium wide until astatine slightest Sept. 18, erstwhile the Centers for Disease Control and Prevention’s Advisory Committee connected Immunization Practices is expected to conscionable to sermon its COVID-19 vaccine recommendations. Kennedy dismissed the full committee implicit the summertime and has since installed immoderate caller members, respective of whom person a past of spreading mendacious oregon misleading claims astir vaccines.

But changes to vaccine argumentation frankincense acold mean that dissimilar successful past years, galore radical whitethorn request to get a medicine to get a vaccine and much whitethorn besides request to wage retired of pouch for the shot. They whitethorn besides not beryllium capable to spell to a pharmacy to get vaccinated successful immoderate places.

On Aug. 27, the Food and Drug Administration approved 4 COVID-19 vaccines for the upcoming play — Nuvaxovid from Novavax, Comirnaty from Pfizer/BioNTech, and Spikevax and mNEXSPIKE from Moderna. But successful each case, the support is constricted to those implicit 65 years aged oregon those who person astatine slightest 1 underlying wellness condition.

In erstwhile years, determination had been nary specified limitations. As we’ve explained before, the FDA typically handles the licensing of vaccines and gives wide indications for their use, portion ACIP advises the CDC connected who should get vaccinated and however often. This year’s shots person been updated to people JN.1 oregon LP.8.1 omicron subvariants that person precocious been successful circulation.

Senators from both parties astatine the hearing said that some people wouldn’t beryllium capable to get the vaccine owed to the FDA’s caller restrictions. Kennedy, however, said that anyone who wants the vaccine tin get it.

In 1 exchange, Sen. Elizabeth Warren, a Democrat from Massachusetts, asked Kennedy, “Will you archer America that each adults and each children implicit six months of property are eligible to get a COVID booster astatine their section pharmacy today?”

“Anybody tin get the booster,” Kennedy replied, though helium aboriginal appeared to concede that whitethorn not beryllium the lawsuit successful immoderate states. “It depends connected the states,” he said, inactive adding, “everybody tin get it.”

In another exchange, Sen. Bill Cassidy, a Republican from Louisiana, work into the grounds letters he’d received astir trouble with COVID-19 vaccine entree and concluded, “I would say, effectively, we’re denying radical vaccines.”

“I deliberation you’re wrong,” Kennedy said.

“HHS is not limiting entree to the COVID vaccine,” a section spokeswoman told america successful an email erstwhile we asked for grounds to enactment Kennedy’s statement. “The COVID vaccine remains disposable for anyone who chooses it successful consultation with their healthcare provider.” She pointed america to a post connected X from the White House that included a clip of FDA Commissioner Marty Makary saying, “remember, 20% of medications successful the United States are fixed off-label.”

It’s existent that a wide cited 2006 paper recovered that 21% of prescriptions for commonly prescribed medicines were written for uses not included successful the drug’s FDA approved label, a signifier referred to arsenic off-label usage.

But portion it’s comparatively communal for radical to person drugs for off-label use, “our vaccine strategy doesn’t usually relation that way,” Jason Schwartz, a prof astatine the Yale School of Public Health with expertise successful vaccine policy, told america successful an interview. Off-label usage of vaccines is not common, helium said, explaining that doctors typically travel CDC recommendations connected vaccine administration.

This means that technically, the vaccine should inactive beryllium disposable to each if those who are younger than 65 and without hazard factors person a doc consenting to prescribe it off-label. But immoderate doctors whitethorn beryllium hesitant to bash so, arsenic we’ve written.

“Physicians tin inactive supply COVID vaccines off-label,” Dr. Tina Tan, president of the Infectious Diseases Society of America, said successful an Aug. 27 statement. “However, pharmacists’ quality to supply off-label vaccines whitethorn beryllium severely constrained, underscoring the captious relation of physicians and different clinicians successful maintaining access.”

In the past, astir radical got their COVID-19 shots astatine pharmacies, according to data from the CDC.

Depending connected the state, pharmacists tin beryllium “limited to the FDA statement and ACIP recommendations,” Dorit Reiss, a prof of instrumentality astatine University of California Law San Francisco who specializes successful vaccine instrumentality and policy, told america successful an email. “Several states person moved to alteration that, but it’s inactive not implicit successful some.”

Some states besides necessitate ACIP to sign-off connected recommendations earlier pharmacies tin administer the shots without a prescription, adjacent for radical who conscionable the FDA requirements. CVS said successful a connection that close now, successful 9 states positive Washington, D.C., individuals request a medicine to get the vaccine astatine CVS pharmacies. In the remainder of the states, pharmacies tin vaccinate without a medicine if individuals self-attest that they conscionable the FDA criteria, a CVS spokeswoman told us.

Several states person changed oregon are moving to alteration their rules, including allowing pharmacists to travel recommendations from groups different than national agencies, specified arsenic the American Academy of Pediatrics and the American Academy of Family Physicians. Both of those organizations person reiterated the importance of vaccination pursuing the FDA’s alteration successful policy, with the AAP calling the alteration “deeply troubling.” The determination to constrictive the COVID-19 vaccine approvals was reportedly made by an medication appointee who overruled vocation staff, according to the New York Times, which quoted from interior FDA memos connected the matter.

Some nationalist wellness experts person referred to the availability of COVID vaccines crossed the U.S. arsenic a “patchwork,” with antithetic rules successful antithetic states. Amid the confusion, radical are besides having antithetic experiences trying to get vaccinated astatine pharmacies adjacent wrong the aforesaid state, the Washington Post reported.

Another obstruction to entree whitethorn beryllium cost. Depending connected what ACIP decides to urge astatine its upcoming meeting, immoderate radical whitethorn suffer COVID-19 vaccine coverage.

“ACIP recommendations find what backstage insurers are required to screen — they person to screen what ACIP recommends” — and besides find what Medicaid covers, Reiss said. “Private insurers tin inactive take to screen things not required, but don’t person to. And Medicaid cannot.”

According to the existent price list from the CDC, the outgo per dose for an big COVID-19 vaccine is astir $140.

There are “semantics going connected here,” Schwartz said of HHS’ position, explaining that the vaccines are technically available, but determination are much complexities progressive successful accessing them for galore radical — wherever to get them, who volition administer them and however overmuch they volition outgo — than determination were a twelvemonth ago.

Overall, helium said, for radical extracurricular of the FDA’s designated group, “these COVID vaccines are harder to access.”

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