COVID-19 hasn’t disappeared, but the way we protect against it is shifting.

In late August, the FDA made an unusual move: it narrowed its approval for the COVID-19 vaccine to just two groups.

• Approved: Adults 65+

• Approved: Anyone 6 months and older with a high-risk condition

That’s a big change from previous years when nearly everyone over six months old was encouraged to get vaccinated.

This shift has caused confusion not only in the public but also within the medical community. Groups like the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists continue to recommend broader use, including for pregnant women and young children. Other organizations, like the Infectious Diseases Society of America, have strongly opposed the FDA’s narrower label. Typically, the FDA, medical societies, and public health groups are in alignment, so this kind of disconnect is rare — and it’s leading to mixed messages for the public.

What Counts as High-Risk?

The FDA did not define exactly who qualifies as “high-risk.” Instead, it pointed to the CDC’s list of conditions, which is quite broad. This means many employees in a workplace may qualify. The list includes:

• 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

 In practice, a large portion of the population may meet one of these qualifications.

How TotalWellness Is Handling Eligibility

For our clinics, simplicity and access remain our priorities. To determine eligibility, we use self-attestation. That means each participant will check a box on the consent form confirming that they have a qualifying risk factor. No documentation is required, and contractors are not expected to verify medical history or request proof. This approach minimizes barriers while still following the FDA’s label.

It’s important to remember that some individuals may still want the vaccine even if they don’t fall under the FDA’s categories. This is called “off-label” use. While physicians can recommend vaccines off-label, most pharmacies and insurers do not allow them to be administered that way. At TotalWellness events, we will stick to our self-attestation process. If a participant does not indicate they qualify, we cannot provide the vaccine.

In these cases, the best advice is to encourage the individual to speak directly with their doctor. Physicians can determine whether vaccination is appropriate and may be able to provide access through their own practice. This helps employees explore their options without putting you, as a contractor, in the position of making that call.

 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. We will update this article if anything changes. 

What Contractors Need to Know

As a contractor, your role is simple but critical. At events, your main responsibility is to make sure participants fill out the consent form and check the self-attestation box if they qualify. You are not responsible for verifying medical conditions, and no additional paperwork is required. Be prepared to answer questions with reassurance: the vaccine remains safe, effective, and important, even if the headlines are confusing this year.

Key Reminders

• Review consent forms carefully.
• Ensure employees check the self-attestation box if they qualify.
• Do not request s proof.
• Be prepared to answer basic questions 
• Emphasize that vaccines remain safe, effective, and important.

At the end of the day, our goal hasn’t changed. We want to make vaccination easy, stress-free, and accessible for workplaces across the country. While the FDA’s label may have shifted, our commitment to clear, simple, and safe clinics remains the same.