Due to changes in criteria and the ongoing upheaval in the regulatory agencies overseeing their uses and approvals, getting an updated COVID-19 vaccination this fall will differ from past years for those who are young and healthy.
The vaccines are no longer broadly approved, as in past years, for anyone ages 6 months and older.
The U.S. Food and Drug Administration in late August approved the updated COVID-19 vaccines only for people ages 65 or older and for those younger only if they have one or more health conditions that put them at higher risk of severe COVID-19.
It’s a major shift from past guidance, resulting in confusion over who is eligible to get a vaccination and where to get them, what it will cost, and whether younger people will need to consult with their doctors to get the COVID-19 shots, which won’t necessarily be widely available in doctors’ offices.
“It’s going to be harder,” said Dr. Scott Miscovich of Premier Medical Group Hawaii. “A major reason why, first of all, is finding these in your regular doctor’s offices is really going to be minimal.”
He has not seen the price for the updated COVID-19 shots yet but said doctors have to consider how many to order. They will not want to spend money, for example, on a box of 10 at possibly $2,250 or more for an unknown number of patients, only to throw them out if unused.
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Another unknown, Miscovich said, is how strict insurance companies will be in evaluating whether younger people meet the criteria for a COVID-19 shot.
He expects about 30% fewer Hawaii residents to get vaccinated than in past years due to the changes.
Retail pharmacies at Longs Drugs, operated by CVS Health, are also offering the updated COVID-19 vaccines. CVS said Hawaii is one of 34 states that allow pharmacies to give vaccines that are FDA-approved. Appointments for the vaccines are available via its app and cvs.com.
Other states, CVS said, are on hold pending authorization from the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which is scheduled to meet Sept. 18 and 19. Yet other states will allow CVS to offer COVID-19 vaccines if presented with a prescription.
Summer uptick
Suzanne Uratani, 75, of Honolulu, has already scheduled an appointment for a COVID-19 shot Monday at a Longs Drugs location. She suffers from adult-onset asthma and has gotten the vaccine and boosters since they were available.
Her partner, Ted, 78, is also scheduled for a COVID-19 shot. He was a longtime smoker before quitting in 2020, she said, and has a heart condition.
They take a multilayered approach, including masking outside of their home, to avoid getting COVID-19 due to these vulnerabilities.
The couple are easily eligible due to their age, but questions linger over the process for younger residents who still want a COVID-19 shot. The CVS app, for now, appears to allow appointments for residents under 65 if self-reporting a high-risk condition.
Hawaii, meanwhile, experienced a summer uptick in COVID-19 cases, with test positivity rates soaring to a high of 16.1% in early August compared to a low of 3.6% in early May.
The state Department of Health’s COVID-19 data dashboard on Wednesday showed a test positivity rate of 13.7% for the week ending Sept. 1, indicating the virus is still circulating in the community at a medium level. Children were impacted, with CDC data showing a spike in COVID-19-related emergency department visits among patients 11 years and younger through August.
Miscovich said many COVID-19 patients came through his urgent-care clinics over the summer seeking treatment.
“This round, we had the razor sore throat,” he said. “A lot of upper respiratory congestion and coughing. They were symptoms that lasted for two to 2-1/2 weeks.”
Conflicting guidelines
While the federal approval process for COVID-19 vaccines over past years was routine, this year’s process is full of strife and disruption, with conflicting recommendations.
In May, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced on X that the government was dropping COVID-19 vaccine shots for healthy children and pregnant women from the immunization schedule, as the CDC subsequently did.
Kennedy, a reputed vaccine skeptic, also fired all 17 members of the CDC’s Advisory Committee on Immunization Practices, saying he did so to restore public trust. The committee’s recommendations affect insurance coverage for vaccines and usually become CDC policy upon adoption by the CDC director, who was also recently fired.
Then in August, the FDA approved but placed age restrictions on the updated Pfizer, Moderna and Novavax vaccines.
FDA Commissioner Dr. Marty Makary posted to X that the new guidelines reflect a risk-tiered approach matching other countries such as Denmark and France, where COVID-19 vaccines are recommended only for older people.
He has also questioned whether younger children need boosters every year when the COVID-19 emergency is over.
Professional medical organizations, however, are countering the U.S. Department of Health and Human Services with differing recommendations.
The American Academy of Pediatrics recommends all children ages 6 to 23 months old get the COVID-19 vaccine, along with older children in certain risk groups. The academy also said parents who want one for their child should be able to get one.
AAP President Dr. Susan Kressly called the decision to limit the availability of the COVID-19 vaccine for children “deeply troubling,” saying it added further confusion and stress for parents.
The American College of Obstetricians and Gynecologists said it continues to recommend all pregnant individuals receive an updated COVID-19 vaccine.
States divided
The conflict over COVID-19 vaccines has divided the nation, prompting some states to band together in support of science-backed vaccine policies, and others to set their own vaccine rules.
Hawaii on Thursday joined forces with the West Coast Health Alliance, comprising California, Oregon and Washington. Together the four states will, according to a news release, provide “evidence-based immunization guidance rooted in safety, efficacy, and transparency — ensuring residents receive credible information free from political interference.”
Massachusetts issued an order requiring insurers to cover the costs of COVID-19 shots, while Florida announced it will end all state vaccine mandates.
In response to the alliance, HHS Communications Director Andrew Nixon said in an emailed statement, “Democrat-run states that pushed unscientific school lockdowns, toddler mask mandates, and draconian vaccine passports during the COVID era completely eroded the American people’s trust in public health agencies.”
Insurance coverage
HMSA, one of Hawaii’s largest health insurance providers, said it will continue to cover COVID-19 vaccines.
“HMSA and professional medical societies around the world have concluded that COVID-19 vaccines are effective at keeping individuals and populations safe,” said Stefanie Park, HMSA chief medical officer, in a statement. “We believe that everyone in Hawaii who wants one should have access to one. Accordingly, HMSA will continue to cover COVID-19 vaccines without cost share for anyone over 6-months-old who desires one, in the same manner we cover it today.”
Kaiser Permanente said it is reviewing the FDA’s approval of this year’s COVID-19 vaccines and will also review the CDC’s clinical guidance when it is released, along with those of relevant medical societies.
“Vaccination continues to be one of the safest and most effective ways to protect against illness and reduce the severity of illness from COVID,” Kaiser said in a statement. “Kaiser Permanente is committed to making the 2025-26 COVID vaccine available at no cost to children and adults for protection from severe illness from COVID.”
The state Health Department also is monitoring developments but has not yet offered detailed recommendations on the vaccines to residents.
“The Department of Health updated its 24-25 COVID-19 vaccine recommendations in July based on updated evidence from the CDC’s COVID-19 vaccine workgroup,” said State Epidemiologist Dr. Sarah Kemble in a statement. “The DOH believes that all individuals aged 6 months or older who desire COVID vaccination should have access to it, and DOH encourages health plans to cover COVID vaccination without cost-sharing, even if it’s for an indication that the U.S. FDA has removed. We will continue to review new evidence as it becomes available and update our recommendations as indicated.”
She added that DOH fully supports the governor’s commitment to making public health decisions based on sound science and evidence-based approaches.
“We look forward to collaborating with the other states in the West Coast Health Alliance to align guidance to best protect public health,” she said. “This shared effort will be useful to provide clear and consistent guidance, including for COVID recommendations for the upcoming 2025-26 vaccine formulations.”
Interest flagging
Even when COVID-19 vaccines were widely available last fall, interest had dropped, with only 13.2% of the state’s population having received the 2024-25 vaccine.
Among youth, rates were even lower. About 12% of residents ages 12 to 17 received the COVID-19 vaccine, as did only 3% of residents ages 5 to 11 and a mere 0.7% of residents ages 6 months to 4 years old.
Miscovich is concerned for patients under 50 who have health risks. He noted the CDC criteria for high-risk conditions are broad-ranging and apply to many residents.
The CDC’s list includes conditions such as asthma, cancer, COPD, heart conditions, diabetes, obesity, depression, pregnancy and physical inactivity, and people who are current or former smokers, among others.
He is recommending the COVID-19 vaccine to his patients, especially with the risk of long COVID still present.
“The COVID vaccination is absolutely safe; the data is crystal clear,” Miscovich said. “You should be looking at it as very similar to a flu vaccination. COVID is with us to stay, and it is not something you want to get.”
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