The rollout of this year’s updated COVID-19 vaccine has more complicated as government agencies have moved away from the universal recommendation for the shot that was in place during the pandemic.
In August, the U.S. Food & Drug Administration announced that instead of being available to anyone 6 months and older, this year’s COVID-19 booster would be approved only for those 65 and older and those 5 to 64 who have at least one condition that puts them at higher risk of infection.
“The list is very broad,” Dr. Laura Morris said. She’s the chief medical officer for ambulatory care at University of Missouri Health Care. “There are many patients who may not be aware that they actually fit into one of those risk categories.”
The list of conditions that make people “high risk” for COVID-19 infections includes many classic, common risk factors, such as diabetes, asthma, heart disease, cancer, being immunocompromised and more.
But it also includes many other risk factors, such as mental health issues, a sedentary lifestyle, obesity, dementia and smoking history, among others.
“I say about 25% of Americans got vaccinated last year and the year before that, so those numbers have declined quite a bit from the earlier part of the pandemic and that 25% has held pretty stable over the last two seasons,” Morris said, “and I think that most of those patients will also still be able to get vaccinated.”
While many Americans are still eligible for the vaccine under the new criteria, Morris said she is worried these new barriers — and the uncertainty that comes along with them — may keep many people have getting their vaccine.
Some of the uncertainty around the COVID-19 booster this year comes from the inconsistent recommendations from different agencies and professional medical organizations.
While the FDA has approved the vaccine, it is the Centers for Disease Control and Prevention that issue the vaccine recommendations that medical providers and pharmacies generally follow.
“This is an evolving process, certainly right now,” Morris said. “There's been a lot of chaos and a lot of confusion, and there's a gap right now in guidance in terms of aligning our federal government agencies with medical specialty societies.”
Multiple professional medical organizations, including the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists have all released statements this year supporting wide access to the vaccine for anyone 6-months-old or older.
“We have experts who are educated and have our patients’ health and safety first and foremost, and we will make the right recommendations for patients,” Morris said. “(People) should reach out to their doctor, their doctor knows what they're doing.”
This “gap in guidance” came from concerns about the CDC’s Advisory Committee for Immunization Practices (ACIP), which meets and determines vaccine recommendations each year.
Earlier this summer, Health and Human Services Secretary Robert F. Kennedy, Jr. fired and replaced all 17 members of the committee.
The committee met in mid-September and ended up voting against adding additional barriers to the vaccination process, such as requiring a physician’s prescription. Instead they called for “immunization based on individual decision-making” and “shared clinical decision-making” with medical providers when it comes to the COVID-19 booster.
This recommendation could open up access to the vaccine to those who do not fit within the age or high-risk criteria set forth by the FDA, but this guidance has not yet been officially adopted by the CDC.
To be official, the ACIP’s recommendations must be reviewed and adopted by the CDC director. The previous director of the agency was fired by Kennedy in August, and the agency is currently being led by Acting Director Jim O'Neill.
So, where does this leave individuals seeking their annual COVID booster?
This week, I went to a pharmacy chain in Columbia and was able to get both my updated COVID and flu shots for the season.
I did have to “attest” two times – once written and once verbally – that I had an underlying condition that qualified me for the updated COVID-19 vaccine, such as my desk job as a journalist.
Morris said they will be using a similar attestation on forms during their large vaccination events throughout the region this fall.
“We plan to offer those COVID vaccines to patients who read the consent form and can attest that they have a risk factor or meet the age requirement based on the FDA authorization,” Morris said.
Austin Krohn, the spokesperson for Columbia/Boone County Public Health & Human Services, said the health department will also continue their vaccination outreach efforts, as they have done in years past – with the addition of an extra checkbox at the end of the paperwork showing a person meets the FDA’s new criteria or have spoken with a doctor.
“It’s just the attestation that they have spoken to a doctor, or that they have one of an underlying condition of some kind,” Krohn said.
He said that the health department is not asking for any proof nor will they be following up to verify if a person actually has a condition that would qualify them for the vaccine.
But he added he is concerned that this extra step — as simple as it may seem — might keep some people from getting vaccinated.
“Yeah, this is essentially a box that you're signing or checking, but it's still another barrier, right?” Krohn said. “Barriers keep people from coming to get their vaccines or do any number of things. It could be the smallest thing, like just checking that box. It's enough to put someone off of it.”
Krohn said that the health department team is happy to help people get their immunizations this fall, but, he admits, it might be simpler for people to get the shot directly from their medical providers this year.
Dr. Lana Zerrer, the chief medical officer at Boone Health, said she always recommends people make health decisions in tandem with their primary care physicians.
“Looking at their risk factors, what their thoughts are on the vaccines, and then really looking at the science together to decide — do you want to risk getting a COVID infection and having all the complications of that, or would you rather get a vaccine?” Zerrer said.
But she recognizes having primary care is a barrier for many folks living in mid-Missouri. According to the Center for Rural Health, 111 of the 114 counties in Missouri are designated shortage areas for primary care physicians.
Zerrer added that she’s concerned the safety of vaccines is being questioned — especially as numerous studies show the vaccine helps prevent hospitalization, severe disease and death from COVID. Plus, she added, people without obvious risk factors can still experience COVID infections and long-term complications, such as Long COVID.
“I am worried, and one of the reasons I'm worried is that I've seen a lot of people that have gotten COVID infections who did not have a chronic illness and then suffered really severe consequences from that infection,” Zerrer said. “So, the fact that someone does not have a chronic medical illness does not protect them from a severe COVID infection or severe complication.”
For those looking for a COVID vaccine, Zerrer said Boone Health has primary care physicians able to take on new patients, and both the health department and MU Health Care will be holding outreach vaccination events throughout the fall.