CDC data shows COVID-19 cases rising in over 26 states, with mild new variants and updated vaccine guidance for adults and children.
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- Michigan is among 34 U.S. states seeing a summer surge in COVID-19 infections, according to the CDC.
- The surge comes as uncertainty swirls about who will be eligible for updated COVID-19 vaccines this fall, insurance coverage and when they’ll be available.
- Part of the uncertainty is driven by a growing rift between leading U.S. medical groups and Robert F. Kennedy Jr., the secretary of the U.S. Department of Health and Human Services.
“Everything is kind of up in the air … with what’s going to be available and what’s not,” said Farah Jalloul-Rizk, chief pharmacy officer with the Michigan Pharmacists Association.
At the center of the uncertainty is a growing rift between leading U.S. medical groups, such as the American Academy of Pediatrics, and Robert F. Kennedy Jr., the secretary of the U.S. Department of Health and Human Services.
He and other top Trump administration health officials changed the recommendations for who should get COVID-19 vaccines in May − saying they should no longer be given to healthy children or pregnant women − and shook up the way in which vaccines are reviewed and recommended in the U.S.
The schism could stall the arrival of newly updated COVID-19 vaccines for fall and drive more confusion about eligibility. It’s led to conflicting recommendations from federal and Michigan health leaders about who should get a COVID-19 booster and might mean some people could have to pay out of pocket for the vaccines or have a co-pay this year.
Some of Michigan’s largest insurance companies, however, told the Detroit Free Press this week that they will continue to cover COVID-19 vaccines for their members.
Blue Cross Blue Shield of Michigan, which provides health benefits to more than 4.7 million people in the state as well as to employees of Michigan-headquartered companies living outside of the state, issued a statement that said, in part: “We want to reassure our members and customers that, at this time, there are no adjustments to our coverage for vaccines.”
Margaret Anderson, president of Health Alliance Plan of Michigan, which as 476,000 members, said in an emailed statement to the Free Press: “Our focus is ensuring members have affordable access to preventive services. All HAP plans continue to cover COVID-19 vaccines. Members should consult their health care providers for medical advice about what’s right for them.”
Priority Health, which has 1.3 million members in Michigan, Indiana and Ohio, “currently provides coverage for the COVID-19 vaccination for people ages 6 months and older as recommended by the CDC’s Advisory Committee on Immunization Practices (ACIP),” said Ryan Nolan, interim vice president of pharmacy for Priority Health.
But, he added: “We continue to review the recommendations coming from the CDC’s ACIP, U.S. Preventive Services Task Force, MDHHS (the Michigan Department of Health and Human Services), the American Academy of Pediatrics, as well as the American College of Obstetricians and Gynecologists.”
Those organizations aren’t all in agreement about what the recommendations ought to be.
What sparked the controversy over this year’s COVID-19 boosters?
The tumult began in late May, when Kennedy Jr. announced on the social media site X that COVID-19 vaccines for healthy children and pregnant women would no longer be recommended because of a “lack of clinical data to support the repeat booster strategy.” He was joined in the videotaped announcement Drs. Jay Bhattacharya, director of the National Institutes of Health, and Marty Makary, commissioner of the U.S. Food and Drug Administration.
The announcement was met with frustration by some medical groups, including the Association of Obstetricians and Gynecologists, which said it would continue to “strongly” recommend COVID-19 vaccination during pregnancy, including updated fall booster shots.
RFK Jr. says COVID-19 vaccine no longer recommended for some
The COVID-19 vaccine is no longer recommended for healthy children and pregnant women, HHS Secretary Robert F. Kennedy Jr. says.
“The science has not changed,” the association said in a statement. “It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families. The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth.”
A couple of weeks later, Kennedy Jr. shook up traditional U.S. health policy again when he ousted all 17 members of the Advisory Committee for Immunization Practices (ACIP), an independent panel of medical and public health experts that makes vaccine recommendations to the U.S. Centers for Disease Control and Prevention. The group reviews the safety and efficacy of vaccines and helps to establish vaccine schedules to control the spread of infectious diseases.
“A clean sweep is needed to re-establish public confidence in vaccine science,” Kennedy Jr. said at the time. He then appointed eight new ACIP members, including some vaccine skeptics.
Those changes triggered a federal lawsuit.
A pregnant physician as well as seven medical groups − including the American Academy Pediatrics, the Infectious Diseases Society of America, and the American Public Health Association − sued July 7 in Massachusetts, alleging that by changing U.S. COVID-19 vaccine guidelines, Kennedy Jr. and other administration officials put “pregnant women, their unborn children, and, in fact, all children … at grave and immediate risk of contracting a preventable disease … with potentially irreversible long-term effects and, in some cases, death.
“This is not a hypothetical concern, but a pressing public health emergency that demands immediate legal action and correction,” the complaint said.
ACIP, FDA clap back against medical groups
By the end of July, the newly appointed ACIP panel that Kennedy Jr. picked notified the American Medical Association and more than a half dozen other medical groups via email that they would no longer be included in reviews of scientific data about vaccines or in creating vaccine recommendations, calling the groups “biased.”
In response, the groups said in a joint statement they were “deeply disappointed and alarmed that our organizations are being characterized as ‘biased’ and therefore barred from reviewing scientific data and informing the development of vaccine recommendations that have long helped ensure our nation’s vaccine program is safe, effective, and free from bias.”
Then came a concern raised by pharmaceutical manufacturer Pfizer, which said the FDA is considering a plan to revoke the emergency use authorization (EUA) for its COVID-19 vaccine, Comirnaty, for use in healthy children younger than 5 years old.
A spokesperson for Pfizer told USA TODAY: “We are currently in discussions with the agency on potential paths forward and have requested that the EUA for this age group remain in place for the 2025-2026 season. It is important to note that these deliberations are not related to the safety and efficacy of the vaccine, which continues to demonstrate a favorable profile.”
The only other COVID-19 vaccine that has been authorized for use in young children − those ages 6 months to 11 years old − in the U.S. is Moderna’s Spikevax.
However, when the FDA granted Moderna authorization for Spikevax in July, it did so with the caveat that only children with at least one underlying health condition that makes them more vulnerable to severe disease from COVID-19 should be eligible for Spikevax.
If the FDA revokes Pfizer’s emergency use authorization for Comirnaty, it means there will be no COVID-19 vaccine with a greenlight for use in young, healthy American children.
What are the current recommendations for COVID-19 vaccines?
The American Academy of Pediatrics (AAP), which has 67,000 pediatricians among its members, said the nation’s infrastructure for reviewing and recommending vaccines had lost credibility. It issued its own guidelines Aug. 19 for who should get COVID-19 vaccines.
The group said all infants and children between the ages of 6 months and 2 years old should be vaccinated because they are at high risk for severe illness from the virus. It also recommends a single dose of vaccine for all children ages 2 to 18 who fall within the following groups:
- Those at high risk for severe disease with COVID-19, including those who are immunocompromised.
- Those who live in congregate settings, such as long-term care facilities.
- Those who previously have not been vaccinated against COVID-19.
- Additionally, children and teens whose household contacts are at high risk for severe COVID-19 disease.
The most updated version of COVID-19 vaccines also should be available to children ages 2 to 18 whose parent or guardian requests it, the AAP said, even if they don’t fall within the groups detailed above.
“We extensively reviewed the most recently available data about COVID-19 risks in kids, as well as safety and effectiveness of available COVID-19 vaccines,” said Dr. Sean O’Leary, chair of the AAP Committee on Infectious Diseases, in a statement. “It’s clear they are very safe for all populations. Among the reasons we decided to move to a risk-based recommendation for healthy older children is the fact that the hospitalization rate for young children and children with underlying medical conditions remains high, in line with rates for many of the other vaccine-preventable diseases for which we vaccinate.”
As of Aug. 21, CDC guidance recommends COVID-19 vaccines only for healthy people ages 65 and older and for people who are older than 6 months of age with underlying health conditions that increase their risk of severe disease from COVID-19.
However, the agency cracked open the door to others who would like a COVID-19 vaccine, saying “shared clinical decision-making” should be used between a health care provider and a patient or the patient’s parent/guardian to determine whether they may be vaccinated.
The Michigan Department of Health and Human Services announced in late July that its recommendation aligns with the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. It supports COVID-19 vaccination during pregnancy, and for every person 6 months and older to protect from serious illness.
“There is strong evidence that supports COVID-19 vaccination during pregnancy and for pediatric patients,” said Dr. Natasha Bagdasarian, the state’s chief medical executive in a statement. “Recent data from the Centers for Disease Control and Prevention show that children under 6 months of age are at the highest risk for hospitalization, and that more than 40% of those hospitalized had no underlying conditions. The COVID-19 vaccine is the best way to prevent complications of infection. We urge Michigan residents talk to their health care providers about getting vaccinated.”
Are any other federal advisory panels likely to see changes?
The CDC’s ACIP isn’t the only advisory panel that could be in Kennedy Jr.’s crosshairs.
The Wall Street Journal reported in late July that Kennedy Jr. also is considering a plan to replace all 16 of the members of the U.S. Preventive Services Task Force, which since 2010 has determined which types of preventive medical care − including cancer screenings, medication, counseling services and tests − must be fully covered by insurance companies.
The Journal’s sources said Kennedy Jr. views the task force members as too “woke.”
In response, the American Medical Association (AMA) sent a letter to Kennedy Jr. and expressed “deep concern.” It urged him to reconsider any plan that would remove current members from the task force.
“USPSTF plays a critical, non-partisan role in guiding physicians’ efforts to prevent disease and improve the health of patients by helping to ensure access to evidence-based clinical preventive services,” the AMA said in its letter.
What other changes are on the horizon?
In June, the newly appointed ACIP panel recommended that a preservative called thimerosal be removed from all flu vaccines in the U.S. Kennedy Jr. signed off on the recommendation in July, requiring manufacturers to change the formulation for flu vaccines to remove the organic compound, which contains mercury, and has been in use since the 1930s to prevent the growth of bacteria and fungi in multi-use vaccine vials.
Jalloul-Rizk of the Michigan Pharmacists Association said even before ACIP voted to remove thimerosal from flu vaccines, there already was very limited use of the preservative, which has been largely phased out the U.S. supply.
“It was mostly used in the multi-dose vials,” she said. “That’s because when you have a multi-dose vial, you’re going in multiple times with a needle, and every time you go in, you can contaminate the vial. … It is not found in single-dose vials. It’s not an issue for most pharmacies.”
Kennedy Jr. heralded the ACIP decision, saying: “After more than two decades of delay, this action fulfills a long-overdue promise to protect our most vulnerable populations from unnecessary mercury exposure. Injecting any amount of mercury into children when safe, mercury-free alternatives exist defies common sense and public health responsibility.”
Jalloul-Rizk said she doesn’t expect to see any other changes to flu vaccines this season.
“The guidance is still the same for that one,” she said. “We’re looking for a rollout at the end of August,” with widespread availability of the updated flu vaccine in pharmacies by mid-September.
“We encourage everyone to get the flu vaccine in September and October. The vaccine takes about two weeks to fully show efficacy, so September-October is the most ideal time for someone to come in,” she said.
But when it comes to the COVID-19 vaccine, she said, there’s still a lack of clarity about what will be available, when it will be available and whether all insurance plans will cover it for all people.
“With changes in the CDC guidelines, I have not heard of any change in coverage or in the age groups who are going to be covered,” she said. “We have asked, but we have not heard anything yet. … The uncertainty of it, that has been an issue.”
For now, she said, Michigan pharmacists are adhering to the CDC’s recommendations and its “shared clinical decision-making” guidance for anyone who is healthy, under the age of 65 and wants a dose of the vaccine.
“It can still be offered if the parent requests it, and it’s agreed upon by a (medical) provider,” Jalloul-Rizk said.
Which types of COVID-19 vaccines will be available this fall?
The FDA’s Vaccines and Related Biological Products Advisory Committee met in May to make recommendations on updated COVID-19 vaccines to be considered for use starting this fall.
The committee suggested vaccine manufacturers should develop formulations that target the JN.1 lineage of the virus, preferentially using the LP.8.1 strain.
But the FDA has yet to authorize any updated COVID-19 vaccine for the fall season, and it’s unclear how soon that might happen or when doses will be available.
Still, the following manufacturers are ramping up production of their COVID-19 vaccines, with hopes they’ll win approval:
- Moderna’s mRNA COVID-19 vaccine, Spikevax, can be used in the U.S. in people who are 65 or older and for those who are 6 months to 64 years old with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
- Pfizer and BioNTech’s mRNA COVID-19 vaccine, Comirnaty, may see its emergency use authorization revoked for use in healthy children younger than 5 years old. Last year, the FDA allowed Comirnaty to be used in Americans ages of 6 months and older.
- Novavax and Sanofi’s COVID-19 vaccine, Nuvaxovid. It’s a protein-based vaccine that does not use mRNA technology and is approved for use in Americans ages 65 and older as well as those who are between the ages of 12 and 64 who have at least one underlying medical condition, such as asthma, cancer, diabetes or obesity, that puts them at higher risk for severe outcomes from COVID-19.
Thomas Grenier, Sanofi’s Head of Vaccines for North America, told the Detroit Free Press: “We are working closely with the U.S. health authorities and our customers to make Nuvaxovid … available nationwide this upcoming season. Pending final FDA regulatory approvals, we expect the product to become available in the early fall. Nuvaxovid will be available at major retail pharmacies and select medical groups in the U.S.”
Grenier said the company expects most private insurance plans, Medicare and Medicaid to cover Nuvaxovid at no cost to patients when administered by in-network providers or pharmacist.
“However, coverage may vary depending on federal recommendations and individual health plans, so it’s important to confirm with your insurer or provider,” he said.
ACIP didn’t vote on updated COVID-19 vaccines at its June meeting and is expected to reconvene in “September/October,” the CDC told USA TODAY.
Meanwhile, the skirmish between Kennedy Jr. and medical groups continues to rage on.
Kennedy Jr. responded Aug. 19 to the American Academy of Pediatrics’ vaccine recommendations, which contradicted the CDC’s guidelines, by noting that among the AAP’s top corporate donors are the pharmaceutical companies that manufacture the vaccines.
“AAP should follow the lead of HHS and disclose conflicts of interest, including its corporate entanglements and those of its journal − Pediatrics − so that Americans may ask whether the AAP’s recommendations reflect public health interest, or are, perhaps, just a pay-to-play scheme to promote commercial ambitions of AAP’s Big Pharma benefactors,” Kennedy Jr. wrote.
AAP President Dr. Susan J. Kressly told USA TODAY: “This attack on the integrity of pediatricians is unfortunate, but it does not change the facts. For nearly a century, the American Academy of Pediatrics’ mission has focused on one thing: following the science to best protect children’s health.”
And still, cases of the coronavirus continue to spread in the U.S.
The CDC reported that as of Aug. 12, the number of COVID-19 infections were growing or likely growing in 34 states, including Michigan. Test positivity is up over the previous week, as are emergency department visits, hospitalizations and deaths from the virus, according to CDC data.
Contact Kristen Shamus: kshamus@freepress.com. Subscribe to the Detroit Free Press.
This story was updated to add a gallery.
