Getting a flu or COVID shot is usually among the most mundane of annual rituals — it’s like tax season with needles. But not so this year.
Instead, changing federal policies and approvals under the watch of vaccine critic and U.S. Health and Human Services Secretary Robert F. Kennedy Jr., combined with new state responses to those changes, has created an unprecedentedly complicated landscape for vaccinations.
“This is understandably incredibly confusing to sort through,” said Dr. David Higgins, a Colorado pediatrician and researcher.
So let’s sort through it. Here are some answers to common questions.
Can I get a COVID shot in Colorado this year?
Do you want the short answer or the long answer?
What’s the short answer?
The federal government has authorized updated COVID vaccines to target more recent variants. But those authorizations contain new restrictions.
Colorado has taken actions to counter those restrictions and keep access widely available. At least for now, it appears that anyone 6 months and older in Colorado won’t be prohibited from receiving an updated COVID vaccine this year if they or their parents choose.
But concerns remain about how many places will offer shots, how much supply will be available, and how much it’s going to cost.
“At a very high level, I think what’s happening is that vaccines are going to be harder to get and more expensive,” said Elizabeth Carlton, an epidemiologist and a professor at the Colorado School of Public Health.
And the long answer?
The federal Food and Drug Administration approved four updated COVID vaccines this year: Two made by Moderna and one each made by Pfizer and Novavax.
But, unlike in prior years, the authorizations contained restrictions. All the vaccines were approved for anybody ages 65 and older. But for people ages 64 and younger, the vaccines are officially restricted for use only in people with medical conditions that place them at a higher risk of severe illness.
What makes someone higher risk wasn’t explicitly spelled out in the approvals, but the Centers for Disease Control and Prevention does maintain a list of what it considers to be high-risk conditions for COVID. It includes conditions like asthma, cancer, diabetes, lung or heart diseases, obesity and several others.
The vaccine authorizations also contained some new restrictions based on age:
- The Pfizer vaccine is approved only for people 5 years and older. This is a big change because Pfizer had once been a vaccine that could be given to younger kids.
- Moderna’s Spikevax vaccine is approved for people as young as 6 months old. It is now the only COVID vaccine authorized for kids under 5.
- Moderna’s mNEXSPIKE, which is a newer COVID vaccine, is approved for people 12 and older.
- Novavax’s vaccine — which uses a protein-based platform instead of the mRNA-based platforms used by Pfizer and Moderna — is also approved for people 12 and older.
FDA approvals of this kind are sometimes called marketing authorizations or labeling requirements. This will become important later in this Q&A.
Why did the FDA impose these restrictions?
The FDA did not release a statement explaining the decisions, which also included rescinding emergency authorizations for some of the vaccines. But on the social media site X, Kennedy said the approvals fulfill prior promises.
“The American people demanded science, safety, and common sense,” Kennedy wrote. “This framework delivers all three.”
The action has puzzled many doctors, researchers and health care authorities.
“The FDA has narrowed the approval for these vaccines, and, from my perspective, it’s not clear what the rationale and the justification was for the narrowing,” Higgins, who is also the vice president of the Colorado chapter of the American Academy of Pediatrics. “There’s not new evidence suggesting new safety risks or changes to effectiveness that would seem to justify narrowing the approval.”
Others have made allegations of political motivation or interference by Kennedy — who formerly led an anti-vaccine organization — and those loyal to him.
Can I get the COVID vaccine if I’m not high-risk?
Yes. The reason is that FDA marketing authorizations are not hard lines that doctors can’t cross.
“People can still receive the vaccine and providers can still give the vaccine, it would just be what we call ‘off-label,’” Higgins said.
That means doctors can prescribe a drug or a vaccine if there is evidence it would help a patient, even if that use falls outside the FDA’s labeling authorization. While this sounds like something extraordinary, it is actually quite common in health care.
One well-known example would be the drug Ozempic, which is FDA approved only to treat diabetes. But it is commonly prescribed off-label for weight loss.
So why were CVS and Walgreens not scheduling COVID appointments?
The two pharmacy chains were scheduling appointments for COVID vaccination in some states, but not in Colorado. The reason has to do with the other half of the vaccine approval process: The go-ahead from the federal Centers for Disease Control and Prevention.
Typically, after the FDA has issued its authorizations — which focus on safety and efficacy — the CDC’s Advisory Committee on Immunization Practices weighs in. The committee reviews data on the vaccine and then makes recommendations on who should receive one. The CDC director then decides whether to adopt the recommendation.
This process is in turmoil this year, first because Kennedy fired all members of the ACIP and replaced them with a handpicked group that includes a number of vaccine critics and, second, because CDC Director Susan Monarez was fired last month after, she said, she refused to blindly sign off on the new ACIP’s recommendation. (In a hearing before Congress last week, Kennedy called Monarez a liar.)
The ACIP is scheduled to meet on Sept. 18 to talk about COVID vaccines. But at least until then, there is no CDC guidance on them.
That was a problem in Colorado because, until last week, state regulations required pharmacists who administer vaccines to follow CDC guidelines. Without those guidelines in place, pharmacies like CVS and Walgreens chose to require a doctor’s prescription to administer COVID vaccines in Colorado.
Why is it a big deal to require a prescription?
In perhaps an ideal world, everyone has a primary care doctor with whom they are regularly in touch and who has the ability to offer prescriptions and in-office vaccinations to all their patients. But this is not the world we live in.
Many patients don’t have a regular doctor, and, even if they do, primary care capacity is strained. This makes pharmacies the backbone of seasonal vaccination campaigns.
For the 2023-24 cold and flu season, pharmacies administered 64% of flu vaccine doses and 90% of COVID vaccine doses.
This explains why Colorado moved so quickly to change its regulations.
What did Colorado do to increase COVID vaccine access?
Last week, Jill Hunsaker Ryan, the executive director of the Colorado Department of Public Health and Environment, issued a public health order that did two big things:
First, it ordered CDPHE Chief Medical Officer Dr. Ned Calonge to issue what is known as a standing order on COVID vaccines. The standing order acts effectively like a prescription written to everybody in the state that certifies people are eligible to receive an updated COVID vaccine. The order still follows the approved age ranges for the various vaccines, though, so it doesn’t allow for a young child to get the Pfizer vaccine, for instance.
Second, Hunsaker Ryan’s public health order instructed the state Board of Pharmacy to consider revisions to its regulations on when pharmacists can administer vaccines.
The health order also instructed various other state agencies, like the ones that oversee Medicaid and regulate health insurance, to do what they can to ensure access to COVID vaccines.
What did the Colorado State Board of Pharmacy do?
The Board of Pharmacy met on Friday and adopted an emergency amendment to its regulations that deleted references to CDC guidelines.
The new regulation instead refers to a part of state law that gives pharmacists authority to provide treatment “that is based on national, evidence-based published guidance.” That section of law also gives pharmacists authority to administer vaccines pursuant to a standing order issued by CDPHE’s chief medical officer.
Are CVS and Walgreens scheduling COVID vaccine appointments in Colorado now?
At least some pharmacies in Colorado do now appear to be scheduling COVID vaccine appointments.
CVS spokesperson Amy Thibault wrote in an email to The Colorado Sun: “Following regulatory action by the state of Colorado, we will ensure COVID-19 vaccinations are available as soon as possible at our CVS Pharmacy locations throughout state.”
On Sunday morning, a Sun reporter attempted to schedule COVID vaccination appointments online at CVS, Walgreens, King Soopers and Safeway locations in Denver.
All of the pharmacies allowed for an appointment to be scheduled, though CVS and Walgreens required people to click a box attesting that they have a medical condition placing them at higher risk of severe illness.
Other medical providers are also working through how they will handle COVID vaccinations this year.
Kaiser Permanente on Friday provided a statement to The Sun saying that it had begun walk-in flu shot clinics at many of its locations and “will start providing the COVID-19 vaccine at these clinics soon, depending on when we receive vaccine supply.”
“We will also review the CDC’s clinical guidance when it is released and evaluate other sources of clinical recommendations, including relevant medical societies, to ensure safe and effective administration of the COVID vaccine,” the statement read.
Even though more people may now be allowed to receive a COVID vaccine in Colorado, it could take time for everyone to be able to find one.
Michael Scruggs, a pharmacist in Englewood who also serves on the state Board of Pharmacy, said at Friday’s meeting that the supplies of COVID vaccines are only now beginning to be distributed to pharmacies around the Denver metro area because the FDA just approved them so recently.
Will insurance cover COVID vaccination this year?
It is unclear how insurers are going to handle coverage for vaccines this year. Their decisions may depend on what the ACIP ultimately decides.
Most insurers are required by federal law to cover vaccines recommended by the ACIP at no charge to patients. ACIP recommendations also are crucial for determining which vaccines are covered by the Vaccines for Children program, which provides free or low-cost vaccines to kids whose families may not otherwise be able to afford them.
If the ACIP recommendations this year stick to the age and health-related restrictions in the FDA’s authorizations, that would mean a large swath of the population may not automatically have their COVID vaccination covered at no cost to them.
Colorado has its own laws on what must be covered, though. The recently issued public health order instructs the Colorado Division of Insurance to make certain that state-regulated insurers are covering COVID vaccines.
But the state regulates only a slice of the insurance market. Companies that are self-insured do not have their plans regulated by the state. Nor do some companies with insurance plans that are based out-of-state. Traditional Medicare and Medicare Advantage coverage also fall outside of state authority.
The easiest way to tell if you have an insurance plan regulated by the state is to look at your insurance card. If the letters “CO-DOI” are in the lower left corner, then you have a state-regulated plan.
Regardless of what is required to be covered at no additional cost, insurers can always choose to cover vaccination.
In its statement to The Sun, Kaiser Permanente said it would do that:
“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 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.”
How do the new FDA guidelines compare to other countries?
The new FDA authorizations bring the United States more in line with what countries in Europe and elsewhere do.
For supporters of the new restrictions, this has been an argument in favor of them. And it’s a point that Dr. Marty Makary, who was nominated by President Donald Trump to lead the FDA, and Dr. Vinay Prasad, whom Kennedy selected to be the FDA’s top vaccine regulator, made earlier this year in an article for The New England Journal of Medicine.
“Although the rapid development of multiple COVID-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment, the benefit of repeat dosing — particularly among low-risk persons who may have previously received multiple doses of COVID-19 vaccines, had multiple COVID-19 infections, or both — is uncertain,” the two doctors wrote.
World Health Organization guidelines affirm the importance of COVID vaccines.
“Safe and effective vaccines help ensure that COVID-19 does not result in severe disease and death,” the organization states on its website. “In 2021 alone, COVID-19 vaccines saved at least an estimated 14.4 million lives worldwide.”
But its guidelines say, “Revaccination (is) not routinely recommended” for healthy adults under the age of 50 and children. The WHO does recommend that adults 50 and older and people with high-risk medical conditions receive an annual COVID shot, and health care workers and pregnant women should also consider receiving an annual dose.
Is COVID still a big deal in Colorado?
Rates of reported COVID infection and hospitalization are certainly not what they were four or five years ago. But COVID continues to have a tragic health impact on Coloradans.
In her public health order, Hunsaker Ryan stated that Colorado has seen 4,575 COVID hospitalizations since Oct. 1 of last year. There were 374 deaths due to COVID in 2024, which is nearly four times the amount of deaths due to influenza.
Most of those deaths are in older individuals, with people 80 and older especially hard-hit. But CDPHE reports that three children have died of COVID since Oct. 1, and there has not been a month this year without at least one COVID death of someone of any age.
My family is healthy. Is it worth it to get vaccinated?
This is, of course, a personal decision. The best advice is to talk with your doctor about vaccination and whether it’s the right choice for you or your family members. If you do not have a doctor, seek out trustworthy sources to inform your decision.
For Carlton, the School of Public Health professor, the decision comes down to thinking not just about her immediate family’s health situation but also that of extended family members such as grandparents.
“We will likely choose to get vaccinated in our family,” she said, “to protect other people in our family.”