TL;DR: The FDA has narrowed COVID-19 vaccine approval to adults 65+ and anyone with a high-risk condition, but major medical groups still recommend broader use. That means guidance is confusing and access may vary.
COVID-19 hasn’t gone away, but the way we protect ourselves from it is shifting.
In late August, the FDA made a surprising move: it narrowed the official approval for this fall’s COVID-19 vaccines to just two groups — adults 65 and older, and anyone six months and up with a high-risk condition. That’s a major change from previous years, when nearly everyone over six months old was encouraged to get vaccinated.
So what does that mean for families, workplaces, and everyday life?
In short: there’s a lot of confusion.
While the FDA narrowed its label, trusted medical groups like the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) continue to recommend broader use — including for pregnant women and young children. Pharmacies, doctors, and insurers are still sorting out what this all means in practice.
Here’s the bottom line: the COVID-19 vaccine is still safe, effective, and a smart choice for many people. The difference now is that the rules feel a bit murkier. That’s why we’re unpacking the latest changes and what they mean for COVID-19 clinics at TotalWellness.
Where We Are Today with COVID-19 Vaccines
Here’s what you need to know about this year’s vaccine guidance:
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Food and Drug Administration (FDA) New Labeling
On August 27, 2025, the FDA changed the license (label) for the the COVID-19 vaccine to people over 65 and those six months–64 years old with at least one high-risk condition. This is unusual because in past years the vaccine was recommended for nearly everyone over six months.
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Professional Organizations Differ
Groups like the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) are still recommending vaccination for broader groups — including children under two, pregnant and postpartum women, and families who want added protection. Other organizations, like the Infectious Diseases Society of America (IDSA), have pushed back strongly, saying the FDA’s narrow label ignores science and puts lives at risk.
And to add more discord, The Vaccine Integrity Project recently convened scientists nationwide to review the latest research on COVID-19, flu, and RSV. After combing through all the evidence, their conclusion was clear: nothing has changed. COVID-19 remains a threat, and vaccines remain safe and effective across all ages.
What makes this moment so unusual is that these kinds of differences rarely happen. As a rule, the FDA, medical societies, and public health groups are aligned. The disconnect this year has led to confusing headlines and mixed messages for the public.
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Why This Year’s Process Feels So Out of Sync
In most years, the vaccine rollout runs like a well-oiled machine. But this year has been anything but routine. The process has unfolded out of order, creating a lot of confusion. One big piece is still missing: guidance from the Advisory Committee on Immunization Practices (ACIP). They’re set to meet in mid-September to review all the data — from safety and effectiveness to side effects and how the virus impacts different groups. After their vote, the CDC director will make the final call.
Put simply, the FDA decides if a vaccine is safe and effective; ACIP sets policy on who should get it. Usually, this guidance comes in June, so the delay has left a lot of people stuck in limbo, waiting for answers.
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What Counts as High-Risk?
The FDA doesn’t spell out who counts as “high risk.” Instead, it points to the CDC’s list — and that list could change after the September ACIP meeting. Right now, the CDC casts a wide net. That means many employees in a typical workplace will qualify as high risk. Conditions include:
- Cancer (current or previous)
- Chronic lung or respiratory disease (e.g. moderate-to-severe asthma, COPD, interstitial lung disease)
- Chronic kidney disease
- Chronic liver disease (e.g. cirrhosis, fatty liver)
- Heart disease or congenital heart condition
- Neurological or cognitive condition (e.g., stroke, dementia, intellectual disability)
- Immunocompromised condition (e.g., HIV not well controlled, organ or stem cell transplant)
- Blood disorders (e.g., sickle cell disease, thalassemia)
- Obesity (BMI over 30)
- Diabetes
- Mental health condition (e.g., anxiety, depression, schizophrenia)
- Pregnancy or recently gave birth
- Disability-related condition (e.g., Down syndrome, cerebral palsy, hearing impairment)
- Smoking or former smoker
- COVID Vaccine Availability Varies by State and Pharmacy
Most national pharmacies are now requiring prescriptions for COVID shots in certain states. Why? The FDA has authorized the vaccine, but the ACIP hasn’t weighed in yet. Pharmacies are being cautious so they’re requiring prescriptions or pausing until guidance is finalized. -
Getting Vaccinated “Off-Label”
What if someone doesn’t fall under the FDA’s label but still wants the vaccine? For example, parents of a healthy one-year-old who want protection because AAP recommends it. It’s possible, but trickier.That’s called getting the vaccine ‘off-label.’ While the term might sound unusual, doctors prescribe off-label every day — it simply means they’re recommending what they believe is best for their patients. Pharmacies, however, usually can’t give vaccines off-label. And when it comes to cost, insurance coverage may vary, which means some people could end up paying out of pocket.
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What’s New in this Year's Vaccine
This year’s formulas have been updated to better match current variants, keeping protection as strong as possible. Moderna's SPIKEVAX will cover children six months and up, Pfizer's COMIRNATY COVID-19 covers 5+, and Novavax's NUVAXOVID covers 12+.
TotalWellness: Making COVID-19 Shots Simple
Even with the FDA changes, TotalWellness is committed to making vaccination easy and stress-free for workplaces. Our medical team stresses that minimizing barriers to vaccination is key to closing gaps in protection.
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We’ll continue to provide on-site COVID-19 clinics for employers who want to protect their teams.
- Our consent forms will include a simple self-attestation question. Employees will just check a box confirming if you have a qualifying risk factor. No extra documentation is needed.
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Vaccinations can be paired with flu shots for a one-and-done clinic.
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Our medical team stays on top of the latest recommendations so you don’t have to sort through confusing headlines.
Why Easy Access Still Matters
COVID-19 hasn’t gone away. Just last week, an outbreak closed a Kansas City school, showing how it can still disrupt our daily lives. And with more than 100 people in the U.S. dying from COVID every week, it’s a reminder we can’t afford to ignore.
Even for those who don’t get severely ill, COVID-19 can leave lasting effects. Long COVID — lingering symptoms like fatigue, brain fog, and shortness of breath — can impact work performance and quality of life for months. Vaccination reduces not just the risk of hospitalization, but also the chance of developing these long-term complications. So having clear vaccination options remains important.
At TotalWellness, our mission is to simplify workplace wellness. That includes flu shots, health screenings — and yes, even COVID-19 vaccinations. The FDA’s label may have shifted, but our commitment hasn’t.
Not sure what the new COVID guidelines mean for you? Ask your questions in the comments below.
