With COVID-19 cases on the rise, shifting federal guidelines spark widespread confusion over vaccine eligibility

Aaron Hardwick woke up one Tuesday in June and immediately knew something was wrong. He felt hot, and his stomach hurt. He soon tested positive for COVID-19.

“The fever, the insomnia and the chills, and the shaking, was out of this world,” said Hardwick, 45, of Rogers Park. “That was something I’ve never had before in my life.”

Hardwick said he was last vaccinated for COVID-19 in 2023. He’d like to get vaccinated again in the future to avoid reliving his recent illness. But he isn’t sure if that’s possible.

“I don’t know what we’re supposed to do,” Hardwick said. “Can we get the shot? Are we supposed to? Who knows?”

With fall approaching and COVID-19 activity rising across the country, confusion over vaccines is widespread. Mixed messages from the federal government have left patients, doctors and public health leaders uncertain about how and which COVID-19 vaccines will be administered to whom in coming months, and what health insurance will cover. The shots can cost more than $100 each without insurance.

Though COVID-19 vaccines released last year are still available at the moment and covered by insurance, the uncertainty surrounds who will be able to get updated vaccines in coming months — shots created to protect against more recent strains of COVID-19. Like flu vaccines, COVID-19 vaccines are updated regularly.

“I think there’s still a lot of confusion among people who would be in the know about what to order, how much to order and the fact we don’t know what’s covered,” said Dr. Emily Landon, an infectious disease specialist at UChicago Medicine, about ordering updated COVID-19 vaccines for the fall. “It’s very difficult to make decisions about what to order if you don’t know how many of your patients are going to qualify for a certain treatment or vaccine.”

Some doctors say they are already starting to get questions from patients about COVID-19 vaccines for the fall, as students head back to school and cases of the illness seem to be rising. Landon and a number of other doctors are recommending people get the most updated vaccines that they can in the fall, and local health departments are moving forward with plans for vaccine clinics, where they hope to offer updated shots to anyone over the age of 6 months who wants them.

As of Aug. 5, COVID-19 infections were growing or likely growing in 45 states, including Illinois, according to Centers for Disease Control and Prevention estimates. In recent years, each summer has brought with it a wave of the illness. Nimbus, also known as “razor blade throat,” was the most prevalent strain of COVID-19 in the U.S. as of June, according to the CDC. Though Nimbus can cause a very sore throat in some people, experts say it doesn’t seem any more severe than previous variants.

Hardwick’s bout with what he believes to be Nimbus was harrowing, he said. He had vivid nightmares and a headache at the base of his skull that was strong enough to completely block out his hearing. About three weeks after he tested positive for COVID-19, he experienced Bell’s palsy, which is when a person has sudden weakness or paralysis on one side of their face. The condition can follow viral infections.

“It’s still pretty serious,” Hardwick said of COVID-19. “I wish we would take it a little more seriously than we are.”

Confusing COVID-19 vaccine guidance

Typically, the CDC’s Advisory Committee on Immunization Practices makes vaccine recommendations in June for the fall respiratory season. Those recommendations help determine who receives vaccines and whether insurance plans will cover them.

That committee, however, has not yet made recommendations regarding COVID-19 vaccines for the fall. All of the committee members were recently replaced at the direction of Robert F. Kennedy Jr., who is the U.S. Department of Health and Human Services secretary.

The U.S. Food and Drug Administration has also not approved any updated COVID-19 vaccines for this fall, though those approvals typically come at the end of August or early September.

Instead, individual federal health leaders have made sometimes contradictory remarks about what to expect in the fall when it comes to COVID-19 vaccines.

In May, leaders of the FDA published an article in the New England Journal of Medicine saying that, moving forward, the FDA would approve COVID-19 vaccines only for people ages 65 and older and younger people with underlying conditions. They wrote that the vaccines would only be approved for healthy adults after “randomized, controlled trial data evaluating clinical outcomes.”

The policy “balances the need for evidence,” wrote the paper’s authors, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, who recently resigned from the FDA as a top official over vaccines .

The trouble is that clinical trials take time, and the COVID-19 virus is constantly changing, Landon said.

“Clinical trials are not feasible because you don’t know what strains to make it for until the strain is here,” Landon said.

Further complicating matters, a week after the New England Journal of Medicine article was published, Kennedy announced in a video posted to social media that the CDC would no longer recommend COVID-19 vaccines for healthy children and healthy pregnant women.

“Last year the Biden administration urged healthy children to get yet another COVID shot despite the lack of any clinical data to support the repeat booster strategy in children,” Kennedy said.

The CDC no longer recommends the vaccine for healthy children, but says it may still be given as part of a “shared decision-making clinical process” between doctors and parents.

Kennedy’s announcement also seemingly contradicted the New England Journal of Medicine article which said the FDA would likely approve the vaccines for people at high risk of developing severe COVID-19, including pregnant women.

A CDC immunization schedule now says “no guidance/not applicable” when it comes to COVID-19 vaccines for pregnant women.

“(Kennedy) just came out and said these two populations don’t need the COVID-19 vaccine, which is completely ridiculous,” said Dr. Tina Tan, a pediatric infectious disease specialist at Lurie Children’s Hospital and president of the Infectious Diseases Society of America.

The Itasca-based American Academy of Pediatrics and five other medical organizations sued Kennedy and other federal health care leaders in early July over the changes.

A spokesperson for the U.S. Department of Health and Human Services said in a statement that with the COVID-19 public health emergency over, it’s time for a new phase in response to the virus.

“A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden Administration is now over,” the statement said.

Illinois health leaders making plans

Illinois health care leaders and pharmacies — where many people typically receive COVID-19 vaccines — say they’re moving forward with plans to administer updated COVID-19 vaccines but won’t know exactly how that will look until they receive further guidance.

The Chicago Department of Public Health hopes to administer updated COVID-19 vaccines to anyone who wants them, said Dr. Alexander Sloboda, medical director of immunizations and emergency preparedness for the Chicago Department of Public Health.

“At this time, we don’t plan to limit (the vaccine) to any particular groups, really anyone 6 months and older should be getting the updated vaccine, but there are some unknowns at the federal level of what the final recommendations will be, what will be available, what the coverage will look like,” Sloboda said.

The Cook County Department of Public Health also hopes to make updated COVID-19 vaccines available to anyone ages 6 months and older, said Dr. Kiran Joshi, chief operating officer at the Cook County Department of Public Health.

CVS Health said in a statement that, “If approved (by the FDA), we plan to carry the updated COVID-19 this fall” cautioning that “patient eligibility will be defined by the FDA and CDC.”

Walgreens also plans to administer updated COVID-19 vaccines this fall, and is also awaiting guidance on who will be eligible for them, said Samantha Picking, senior director of immunizations at Walgreens.

The Illinois Department of Public Health plans to release an advisory regarding COVID-19 vaccine recommendations as it gets closer to the fall respiratory season, after consulting with the state’s Immunization Advisory Council, state health leaders and national experts, the state health department said in a statement.

States typically follow CDC recommendations, but that could change given all the disagreement over vaccines this year.

When asked whether providers could follow state recommendations rather than federal ones, if the two differ, a spokesperson for the state health department said in an email: “Yes. As always, health care providers should use evidence-based practice and patient-centered clinical judgment to make individual patient-care decisions.”

But even if providers choose to give updated COVID-19 vaccines to healthy, younger adults, questions remain about whether health insurance will cover the shots. Federal law requires insurers to cover vaccines recommended by the Advisory Committee on Immunization Practices and adopted by the CDC director, according to KFF, a nonprofit organization focused on health policy. It’s unclear whether that committee will recommend updated COVID-19 vaccines for everyone. Without insurance, COVID-19 vaccines can cost as much as about $130 or $140 a dose, according to the CDC.

The largest health insurer in Illinois, Blue Cross and Blue Shield of Illinois, said in a statement it has not made any changes to its coverage for COVID-19 vaccines, but it is monitoring “any activity that may impact preventive care recommendations and will communicate any changes to recommendations that may impact standard coverage of preventive services.”

Health insurance industry group AHIP said in a statement in late June that, “We are committed to ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season.”

The many lingering questions have left people like Roger Naglewski, 55, wondering if they’ll be able to get COVID-19 vaccines in the fall. Naglewski runs the Facebook group Chicago Vaccine Hunters, which started several years ago when finding scarce doses of COVID-19 vaccines felt akin to winning the lottery.

“I want to get one at the next opportunity I can,” Naglewski said of COVID-19 vaccines. Even though more treatments for COVID-19 are available now than several years ago, “I just don’t want to get sick for 10 days and get knocked off my feet. In addition, I don’t want to have any of the issues people have had with long haul COVID.”

He worries, however, that many people won’t get vaccinated against COVID-19 this year, given all the confusion and upheaval.

About 59% of adults surveyed by KFF say they will “probably not” or “definitely not” get a COVID-19 vaccine this fall. That would be in line with COVID-19 vaccination trends in recent years. As of the end of June, only about 12% of Illinois residents had received at least one dose of a COVID-19 vaccine updated for the 2024-25 season, according to the state health department.

“This administration has basically been putting out nonscientific information and what’s happening is this is causing severe confusion among the public,” said Tan, with Lurie and the Infectious Diseases Society of America. “What the public needs to do is you need to speak to your health care provider that you have a good relationship with to get sound scientific information on why getting vaccinations is so important.”

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