Patients have been asking me the same question all week: is the new COVID-19 vaccine out yet? As of late August 2025, updated shots targeting the LP.8.1 subvariant have FDA clearance and are expected to ship this fall. Not everyone will be able to get one.

The FDA has cleared vaccines from Pfizer, Moderna, and Novavax, but eligibility is narrower than it was. You need to be 65 or older, or have a qualifying condition such as asthma, obesity, diabetes, immunosuppression, or a smoking history. Moderna’s shot is cleared for children six months and up with underlying conditions, Novavax from age 12. Healthy younger adults, healthy children, and pregnant women are no longer routinely included (AP News, The Cut).

The shift followed HHS Secretary Robert F. Kennedy Jr. removing vaccine recommendation language for healthy children and pregnant women, in favor of what he described as shared clinical decision making, meaning healthy people need to discuss vaccination with a physician rather than walk into a pharmacy. He has framed the change around science, safety, and common sense (The Cut). Professional organizations saw it differently.

The American Academy of Pediatrics, American Academy of Family Physicians, and American College of Osteopathic Family Physicians all pushed back. The AAP called the guidance deeply troubling and warned that pulling the shots from routine schedules leaves children exposed. AAFP and ACOFP argued for broader access with winter respiratory season approaching (AP News).

Pharmacies are handling this inconsistently. CVS now requires a valid prescription to vaccinate adults in some states, which means eligibility alone may not get you a shot. Coverage is unsettled too. Doses may run $140 to $150 if insurance does not pick them up. Medicare will cover eligible seniors, while adults and children outside the eligible groups may be paying out of pocket (Times of India, The Cut).

So where does that leave you? Doses should reach clinics and pharmacies by mid-to-late fall, roughly on flu season timing. If you are eligible under the FDA criteria, you probably do not need a prescription. If you fall outside them, expect to need a visit, a written order, and your own money.

A few situations that have come up with my own patients recently.

A healthy parent of young children called to ask whether they could simply walk into CVS once the vaccine arrived. They were told prescriptions only, and they did not qualify under the current rules anyway.

A patient in her seventies with COPD wanted to know when it would be available. I told her early fall was likely and that she should not wait once her pharmacy had it.

A pregnant nurse called wondering whether she could get one. I explained the CDC no longer recommends it in healthy pregnancy, and that we would revisit if she developed asthma or another risk factor.

CDC definitions of high-risk individuals under 65

For patients below the routine age cutoff, the CDC still defines groups at high risk of severe illness and hospitalization, and these patients may qualify under the current FDA authorization:

• People with chronic lung disease including moderate-to-severe asthma, COPD, pulmonary fibrosis, or cystic fibrosis.
• People with heart disease, including heart failure, coronary artery disease, or congenital heart disease.
• People with diabetes, type 1 or type 2.
• People who are overweight (BMI 25 or above), obese (BMI 30 or above), or severely obese (BMI 40 or above).
• People with weakened immune systems, whether from cancer treatment, transplant, HIV, or immunosuppressive medication.
• People with chronic kidney or liver disease.
• Current and former smokers.
• Pregnant patients with co-existing conditions that raise their risk.

What clinicians and patients can do now

Make sure patients know their own risk category. Those over 65, immunocompromised, pregnant with risk factors, or managing chronic illness still qualify, and in many cases without a prescription.

Offer a telehealth visit to anyone who thinks they need a physician’s order. I do not yet know whether Teladoc, MDLive, or Amwell will handle vaccine prescriptions this season; I would expect that to be under discussion internally at all three.

Tell patients to call their pharmacy early in the fall and ask what they stock and what their rules are. The rules are not uniform.

Warn patients that coverage may hinge on new CDC guidance. If they are healthy and not recommended for the shot, they should plan on paying for it.

Keep pushing masking, distancing, and flu vaccination. A seasonal bump alongside influenza and RSV is plausible, and fewer vaccinated people means more pressure downstream (AP News).

The frustration is fair. This is no longer one recommendation that covers everybody, and the layering of political change on top of clinical guidance has made it genuinely confusing. What it is not is an abandonment of science. Federal agencies narrowed eligibility, medical societies objected, pharmacies adjusted, and patients now have to go through a physician more than they used to. Timing still points to this fall, and we will know more as orders and shipments start moving.

That is where things stand. Questions are welcome.

Scott Rennie, D.O.

Board Certified in Obesity Medicine and Family Medicine

This blog is for educational purposes only and does not constitute individual medical advice. Always consult your own physician before making changes to your health, medications, or treatment plan.