Washington Post: RFK Jr. says anyone who wants a covid shot can get one. Not these Americans.

Pharmacies and doctors are struggling to adjust to a new regulatory environment for updated coronavirus vaccines that are no longer broadly recommended.

Health and Human Services Secretary Robert F. Kennedy Jr. told senators last week that anyone can get a new coronavirus vaccine. But many Americans are finding the opposite.

Confusion is rippling through the health care system as pharmacies and doctors try to adjust to providing a vaccine that is no longer broadly recommended. Americans’ experiences vary widely, from easily booking appointments to having to cross state lines to access the shots, according to more than 3,200 submissions to The Washington Post’s request for readers to share their experiences.

Chain pharmacy locations in some parts of the country have yet to stock the shots or are turning away patients seeking the updated vaccines manufactured to protect people from the worst effects of new strains of the coronavirus. In some states, they require prescriptions, a step that has largely not been required since vaccines became widely available in early 2021.

Even more confusing: Pharmacies are reaching different conclusions about whether they’re allowed to administer coronavirus vaccines, even in the same state. And some states, including New York and Massachusetts, have scrambled in recent days to rewrite their rules to make it easier to get shots.

Many patients puzzle about whether they qualify to get the shot at all, or if they remain free as in years past.

Officials in the Trump administration have insisted that the new coronavirus vaccines remain available to those who want them and have blasted those who have suggested otherwise. Some Republican leaders are casting doubt on the safety of the shots, while some Democratic governors are rushing to preserve access — underscoring the nation’s deepening political divide over vaccines.

In Washington, D.C., Vernon Stewart, a 59-year-old retired parking enforcement officer, spent Wednesday riding his bike to see a doctor to get a prescription for the vaccine and to find a pharmacy where he could get it, only to be told the shot was not available. At one CVS, Stewart was seated in the chair with his sleeve rolled up when a nurse emerged to tell him his Medicaid insurance plan didn’t cover it.

On Friday morning, he hopped on the Metro train to Temple Hills, in Maryland — a state where CVS is not requiring prescriptions. He didn’t have to show his insurance card and paid nothing for the shot. He left with a bandage on his arm and a free bag of popcorn.

“It shouldn’t have to be this hard,” Stewart said Friday. “It was such a hassle. But I found a way.”

Doctors have the option to provide coronavirus vaccines “off label” to lower risk groups without approval from the Food and Drug Administration. Amid the fierce debates about coronavirus vaccines and low uptake of the latest versions, plenty of Americans want them.

Some, like Stewart, simply want to protect their health, despite not being considered at high risk. Many care for elderly or immunocompromised people and don’t want to get them sick. Some want to be immunized before traveling abroad or to reduce their risk of long covid.

Research has shown that annual coronavirus vaccinations reduce hospitalization and death, especially in people with weaker immune systems because of their age and underlying conditions. Health officials in the Trump administration argue that a universal recommendation is no longer warranted, because clinical trials have not demonstrated the vaccines are effective at reducing infection or transmission in younger and otherwise healthy people who are at low risk of hospitalization. Past research into updated coronavirus vaccines suggests they confer short-term partial protection against infections and can reduce transmission by reducing viral loads and symptoms.

Under Kennedy, the FDA in August narrowed approval of updated coronavirus shots to those 65 and older and people with underlying conditions that elevate their risk of severe disease. Typically, a Centers for Disease Control and Prevention advisory committee meets soon after such an announcement — often a few days later — to recommend which Americans should get coronavirus vaccines. The recommendations, which previously applied to everyone ages 6 months and older, compel insurers to pay for the vaccines.

But this year, the CDC panel was thrown into turmoil when Kennedy fired its members and replaced them with his own picks, most of whom have been critical of coronavirus vaccines. The panel is now scheduled to meet Sept. 18-19.

The vast majority of Americans receive coronavirus shots at pharmacies. More than a dozen states limit the vaccines that pharmacists can give without a doctor’s prescription to only those recommended by the CDC advisory panel, according to the American Pharmacists Association, complicating efforts even for those who are seniors or have preexisting conditions as approved by the FDA.

Five Democratic-led states — Colorado, Massachusetts, New Mexico, New York and Pennsylvania — have recently issued orders to pharmacies to provide coronavirus vaccines without a prescription.

At CVS, the nation’s largest pharmacy chain, prescriptions are still required for coronavirus vaccines in Louisiana, Maine, New Mexico (where the order has yet to take effect), Utah and West Virginia. Patients in higher-risk groups can receive them through CVS Minute Clinics to bypass prescription requirements in Arizona, Florida, Georgia, North Carolina, Virginia and D.C.

The nation’s other two largest pharmacy chains — Walgreens and Walmart — have not provided a list of states where prescriptions are required to get the vaccine.

In a combative appearance before the Senate Finance Committee on Thursday, Kennedy bristled when Sen. Maggie Hassan (D-New Hampshire) accused the Trump administration of taking steps that deny people vaccines.

“Everybody can get the vaccine. You’re just making things up,” Kennedy said. “You’re making things up to scare people, and it’s a lie.”

In Virginia, Elaine Cox said she and her husband asked their doctor for a prescription before leaving Saturday for a vacation in Italy. The office declined because it hadn’t received CDC guidance. Cox, 68, suffers from chronic lung disease, and her nephew died of the viral infection in 2022.

“I was crying this afternoon about this,” she said on Thursday. “My family takes [covid] very seriously.”

Pharmacy employees have given conflicting instructions about how to get coronavirus vaccines, patients report.

In San Antonio, 78-year-old Brant Mittler was told at a CVS Minute Clinic that he needed a prescription on Monday, even though the pharmacy includes Texas among its no-prescription states. The next day, a pharmacist at the same clinic told him it wasn’t needed.

In states where CVS does not require prescriptions, coronavirus vaccine appointments aren’t available for younger, healthier people outside the recommended categories. But the list of qualifying medical conditionsincluding physical inactivity, being overweight or a history of smoking, is so long that nearly anyone who wants a shot should be able to get one, said Amy Thibault, a CVS spokeswoman.

“If you’re five pounds overweight, you qualify,” she said. “If you’ve smoked a cigarette once, you qualify.”

Some people seeking prescriptions from their doctors face pushback.

In Louisville, Stephen Pedigo said his primary care doctor recommended against receiving the vaccine, arguing that covid is mild and that the vaccine has “a lot of complications,” including heart problems, according to a screenshot of their messages.

The most recent CDC guidance says coronavirus vaccination is “especially important” if you are 65 or older and notes vaccines underwent the most intensive safety analysis in U.S. history.

Pedigo, who is 66 and has undergone a heart valve replacement, insisted, and the office gave him the prescription. He received the shot at a CVS on Friday. “I trust the vaccines are safe,” Pedigo said.

Doctors offices also have reported challenges helping patients get vaccinated.

In Raleigh, North Carolina, pediatrician Mary-Cassie Shaw said her office has preordered from Moderna hundreds of shots, at $200 a dose, but worries that insurers won’t provide reimbursement.

Families for the past month have been asking for coronavirus shots to go along with flu vaccines, she said.

One 12-year-old immunocompromised girl went to CVS but needed a prescription from Shaw — who was asked by the pharmacist to rewrite the prescription to include certain diagnosis codes indicating why the patient needed the vaccine.

“I have to do the legwork to come up with the codes that might qualify them,” Shaw said. “It’s a huge barrier. It’s ridiculous.”

Vaccination rates for the latest coronavirus shots have been low, particularly for people not considered at high risk, according to CDC estimates. For adults, uptake of the 2024-2025 vaccine ranged from 11 percent for younger adults to nearly 44 percent for those 65 and older. Roughly 13 percent of children between 6 months and 17 years received the shot.

The most effective way to increase vaccine uptake is to make it easier for people to get the shots, said Noel Brewer, professor of public health at the University of North Carolina Gillings School of Global Public Health. In states such as North Carolina, the added step of getting prescriptions will prompt many people to not bother, he said.

“They might even just hear about other people having a hassle and decide to go back another time and never get back to it,” said Brewer, who studies patient behavior in regard to vaccines.

Last week, California, Hawaii, Oregon and Washington announced plans to form a “health alliance” to coordinate vaccine recommendations based on advice from national medical organizations rather than the federal government, because, they said, federal actions have raised concerns “about the politicization of science,” according to a joint statement.

Massachusetts Gov. Maura Healey (D) announced Thursday that her state would be the first to require insurance companies to cover vaccines recommended by the state’s Department of Public Health, even if the CDC does not. Washington state government officials on Friday recommended coronavirus vaccines for people ages 6 months and older.

At 59, Brewer doesn’t fall into the category of people for whom the FDA recommended updated coronavirus vaccines. Instead, Brewer said, he will wait until the fall, when he might travel to a blue state.

https://www.msn.com/en-us/health/other/rfk-jr-says-anyone-who-wants-a-covid-shot-can-get-one-not-these-americans/ar-AA1M32EI

MSNBC: What the FDA’s new Covid vaccine policy is really about

With the current leadership at FDA and HHS, the incentives are simply stacked against humane vaccine policy.

On Tuesday, the Food and Drug Administration announced plans to significantly curtail people’s access to Covid-19 vaccines. Under the new framework, outlined in an article published in the New England Journal of Medicine by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad, routine approval of updated vaccines will be limited to the elderly and vulnerable only. Approval for the rest of the “healthy” population will require extensive, costly testing.

While Makary and Prasad claimed their policy “balances the need for evidence,” critics noted a number of problems with the plan right away. Some of the research demanded for broad approval of new Covid vaccines was infeasible and even unethical. There were no carve-outs for caregivers upon whom vulnerable people depend. The timing of the release appeared primed to usurp the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which makes vaccine recommendations.

The success of those efforts may have contributed to Trump’s return to office after mismanaging the crisis during his first term. The president himself seems to think so. Last month, the White House replaced the informational covid.gov website with a new page promoting the speculative lab leak theory of the pandemic’s origins and featuring sections on the harms of lockdowns and mask mandates.

The FDA’s new guidance on Covid vaccines can be seen as an extension of this effort, using the imprimatur of the agency to validate misleading and false narratives promoted by the right about the Covid — namely that the vaccines are insufficiently tested with unknown effects and unsuited for young people. Indeed, the authors of the policy were themselves prolific spreaders of those narratives.

The FDA commissioner role was the big prize, however. Serving under his ally, Health and Human Services Secretary Robert Kennedy Jr. — a longtime anti-vaccine activist who called the Covid jab “the deadliest ever made” — Makary was bound to take a stab at the vaccines.

All of the signs were there. One of his first acts was to bring on another vaccine skeptic, Dr. Tracy Beth Høeg, a physical medicine doctor and epidemiologist who had worked in Florida Gov. Ron DeSantis’ Health Department, as his special assistant. The pair had collaborated on a Brownstone project called the Norfolk Group, which crafted an outline for a congressional inquiry into the federal Covid response ahead of the subcommittee hearing. With Høeg on the team, Makary’s FDA held up the scheduled approval of the Novavax booster, eventually scaling it back and limiting it to the elderly and the vulnerable in a precursor to Tuesday’s policy announcement.

Earlier this month, Makary also brought Prasad into the agency as its top vaccine regulator. Prasad, like Makary, has a link to Brownstone and spent years criticizing the FDA over Covid jabs, hyping up safety concerns about rare side effects like myocarditis, questioning their efficacy and suggesting that the risk-benefit ratio disfavored approval.

As The Wall Street Journal noted the previous month in an infographic, the bivalent doses did not need to undergo human testing for safety since the original omicron strain vaccines did. “The changes simply update proven shots,” the graphic explained. “The process is similar to the development of the annual flu shots, which are given without testing them in people.”

Billions of doses have been given over the years. There has been extensive safety monitoring of the vaccines, which have saved millions of lives in the United States and prevented even more hospitalizations. The data shows they reduce Covid transmission and the odds of getting long Covid and offer robust protection against severe illness and death.

With the current leadership at FDA and HHS, the incentives are simply stacked against humane vaccine policy. The only question is how far the agency will go. Is this new guidance the start of a complete phase-out of the vaccines, and might other immunizations follow? Time will tell.

https://www.msnbc.com/opinion/msnbc-opinion/trumps-new-covid-vaccine-restrictions-are-right-wing-conspiracy-theori-rcna208317