Booster Dose: New COVID Vaccine Access Explained

Summary

Heather brings you a bonus mini Booster Dose episode to explain everything you need to know about the changes in FDA approved access to fall COVID shots, who’s eligible by brand/age, what counts as “underlying,” off-label/insurance realities, why ACIP mainly affects coverage (not labels), a brief CDC leadership update, and practical protections—documentation, ventilation, high-filtration masks, testing, and an antiviral plan.

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Full Episode

[This post and the audio were updated 8/29 to clarify that ACIP hasn't met yet to decide on new COVID vaccines, so until they do, the new covid vaccines are not "ACIP-recommended" and so are likely not covered by any insurance for anyone, even those who are approved for on-label use]

Hey guys, today is a mini episode...an emergency booster dose...to help you make sense of the new FDA changes to COVID vaccine access in the US. I'll go over what exactly changed, who’s still eligible, what families can do right now, and how to talk with your pediatrician if your child is healthy but you still want the shot.

First, let me walk you through what COVID vaccine access was before RFK and then how that has changed and what it means, practically, for you. (1) Before this year, COVID shots were on the routine CDC schedule for everyone ≥6 months, so kids and adults were on-label which meant everyone could get the vaccine and insurance had to cover it. (2) After the ACIP shake-up, the CDC listed pediatric COVID on the schedule but under something called shared clinical decision making or SCDM—you and your clinician could talk about it and choose it, and because the FDA label still allowed pediatric use, pharmacies and insurers went along.

Let me pause here to clarify the relationships between FDA approval, ACIP and SCDM, because it matters for access and insurance. ACIP is the Advisory Committee on Immunization Practices within the CDC that provides advice and guidance on effective control of vaccine-preventable diseases. ACIP doesn’t license vaccines—the FDA does. The FDA licenses vaccines for certain demographics. ACIP issues recommendations about who should get what and when, and insurers and programs usually follow those recommendations for coverage. We currently have no recommendation from ACIP for new fall covid vaccines. This means until ACIP meets in Sept, insurance doesn't have to cover the new covid vaccines even if you are on-label and fully eligible. It also means pharmacies who can only give ACIP recommended vaccines (in nearly half of US states), cannot give new fall COVID vaccines. ACIP also decides which vaccines fall under shared clinical decision making, where old COVID vaccines were before yesterday.

As of yesterday, Aug 27, 2025, The FDA approved licenses for this fall’s COVID shots from Pfizer-BioNTech, Moderna, and Novavax, but with significantly tighter labels than last year. In plain English: everyone 65 and older is eligible. For people under 65, you now need at least one qualifying underlying condition to be on-label. Moderna’s Spikevax is approved for ages 6 months–64 with a qualifying condition; Pfizer’s Comirnaty is approved for ages 5–64 with a qualifying condition; Novavax’s protein-based shot is approved for ages 12–64 with a qualifying condition. Kids under 5 no longer have a Pfizer option. These are FDA approvals—not emergency use authorizations—and they reflect an intentional pivot away from last year’s “everyone 6 months and up” approach. So before yesterday COVID vaccines were under SCDM but now a healthy child is no longer on-label to get the vaccine even if the CDC page still shows it in the schedule under SCDM. And that's because shared clinical decision-making is about counseling, not licensing.  

Now sometimes ACIP recommends uses that aren’t literally printed on the FDA label, but that doesn’t force clinics or pharmacies to administer those doses, and it doesn’t obligate insurers to pay unless ACIP is adamant. Bottom line this season: with FDA labels narrowed and ACIP not having met, new fall shots will most likely be out of pocket until ACIP makes a recommendation. Call your insurance to find out. If ACIP does recommend new COVID vaccines when they meet, practical access for healthy under-65s will remain limited to documented risk conditions or case-by-case off-label paths.

So, what counts as a “qualifying” condition for you to be eligible for on label for the COVID vaccines. Clinicians lean on CDC’s risk lists—think asthma and other chronic lung disease; heart disease; diabetes; chronic kidney disease; immunocompromise; obesity; pregnancy; smoking; and more. Risk is cumulative: more conditions raise risk further. If you or your child have a qualifying condition, bring that documentation to your doctor appointment. A simple, accurate problem list—for example, “mild persistent asthma,” “BMI ≥30,” “Type 1 diabetes”—and make sure they have it documented in their system. That documentation is what will enable on-label vaccination this fall. If you’re trying to decide whether your situation “counts,” remember that risk is a spectrum. Many common, bona fide conditions qualify. If something applies to you or your child—even if it’s well controlled—ask your clinician to document it so you can proceed on-label.

So what about those younger than 65 with no documented underlying health conditions who are now off-label? Well, because these products are FDA-approved (not under EUA for these uses), physicians generally may prescribe them off-label as part of the practice of medicine in the US. That’s legal and not unusual in pediatrics. Even when a physician is willing to prescribe off-label, many health systems and retail pharmacies administer only according to FDA label and ACIP standing orders. That’s a site-policy and contracting choice, not a medical judgment about you—so the roadblock may be the pharmacy or clinic’s rules and their insurer contracts, not your doctor.

So where does insurance fit in here? OK, so under the Affordable Care Act, most private plans cover ACIP-recommended vaccines without cost-sharing. If ACIP narrows or stays quiet, plans typically narrow with it. That doesn’t change the FDA labels—it changes payment. So if you’re on-label and ACIP explicitly recommends your group, you have coverage. If you’re not on-label, expect denials unless your plan makes an exception. And if ACIP says they don't recommend the new vaccines, then they will be out of pocket too. We would need state-level intervention to get affordable, accessible COVID vaccines. Don’t assume coverage this year; call and get the answer in writing.

Also, RFK made a comment about how doctors prescribing the vaccines off-label would be legally liable. He's trying to scare doctors into not prescribing it off-label when families want to get their healthy kids or themselves vaccinated. Now he can't actually follow through on that threat, not right now anyway. Doctors are protected legally for prescribing COVID vaccines off-label by the Public Readiness and Emergency Preparedness or PREP Act, which authorizes the Secretary of HHS to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines. And in 2020, the Secretary invoked the PREP Act for COVID and pre-RFK, HHS extended those protections through the end of 2029. That protection does not hinge on whether a use is “on-label". So technically, right now, Doctors are legally protected for prescribing COVID vaccines off-label. But that doesn't mean RFK won't 1) go after doctors anyway and make them go through a court process where they'd be cleared but would be a giant hassle, or 2) he could revoke the extension to 2029. Either way, some doctors may decide it's not worth the hassle.

If you can't get vaccinated, what can you do to reduce your risk of getting COVID? If you’re not on-label, stack other protective layers while you sort access. Improve your indoor air—open windows when you can, run the HVAC fan on “on,” and use a HEPA purifier sized to the room. Mask smartly in crowded indoor spaces with a well-fitting N95, KN95, or FFP2, especially if you’ll be around someone vulnerable. And this is really important guys. After high-risk exposures, isolate yourself as best you can and test on days 2–3 and again on days 5–6. Testing works. It can tell you if you're infected so you can protect those around you, and it can tell you if you're not infected and can relax. And the at-home tests are fine! When I had COVID, both times, my symptoms started 2.5 days after exposure. So, after my next potential exposure situation I will test on day 3. And if no symptoms I will test again on day 5. And I will stay away from people until I have an answer. And testing is also important because COVID increases your risk of other health problems. We're finding more every day about how COVID infection compromises our health. So it's important to track your COVID history. It could impact where doctors look for explanations and treatments for unexpected health problems down the road.

And make a plan with your clinician now, about antiviral treatment if you qualify; early treatment remains key for people at higher risk. If you’re pregnant, the guidance from obstetric groups continues to support COVID vaccination in pregnancy and access to evidence-based care.

Now, a news break that landed the same day as the label changes, updated last night. Earlier reports said CDC Director Susan Monarez was out and four senior leaders—Debra Houry (chief medical officer), Demetre Daskalakis (vaccination recommendations), Daniel Jernigan (vaccine safety), and Jennifer Layden (public health data)—had resigned, citing the weaponizing of public health. Monarez’s attorneys then said she had neither resigned nor been fired and would not resign. By about 10 p.m. Eastern, the White House said it had fired her after she refused to resign over vaccine policy. As of recording (Aug 28, 2025), the White House says Dr. Monarez is fired; her lawyers say she hasn’t resigned and disputes the firing’s validity. CDC’s site now lists the director’s chair as vacant. I'll update this post if that changes. However this ultimately resolves, the timing matters: it hit the same day FDA narrowed vaccine access, so CDC communications may be messy for a bit. The rules that affect you today are still FDA labels and site policies. And a reality check: don’t count on CDC for clear vaccine guidance while the brain-worm is in charge—look to the American Academy of Pediatrics and your state health department, and to me; I’ll keep breaking this down and pointing you to evidence-based choices.

Let’s end with a clear takeaway. The science on risk hasn’t changed: older age and certain conditions drive severe outcomes, though we can predict who among those without underlying conditions will get hammered by COVID, and vaccination reduces those risks. What changed is the policy gate. And here’s why access matters: COVID isn’t just an acute illness. Each infection carries non-trivial risk of new or worsening heart, brain, and metabolic problems, including Long COVID, and those risks add up with repeat infections. Vaccinating only the “vulnerable” doesn’t protect them if everyone around them is repeatedly infected—the cocoon leaks. Plus, healthy people getting repeated infections will not remain healthy. COVID will take a toll. The sane, prevention-first approach is broad vaccination plus clean air and timely treatment.

As of today (August 28, 2025), the FDA’s new rules are in effect. The agency has approved the updated 2025–2026 COVID-19 vaccines, while ending authorization for the older versions—so you won’t find last year’s shots on the shelves anymore. The new vaccines are only approved for adults 65 and older, and for children and adults of any age who have certain high-risk conditions. For healthy kids and younger adults, there’s currently no FDA-approved option, and whether insurance will cover the new vaccines depends on what ACIP and CDC decide at their September meeting. At this moment, without ACIP recommendation, it likely won't be covered. Call your insurance provider to find out. Also, don’t count on ‘beating the system’: pharmacies update their standing orders quickly and insurers can deny or claw back off-label claims. If you’re not on-label but your clinician is willing to prescribe off-label, expect in-office administration and out-of-pocket costs, since most retail pharmacies won’t do it. In the meantime, rely on the layers that work—cleaner indoor air, a well-fitting mask in higher-risk settings, smart testing after exposures—and have an antiviral plan ready if you qualify.”

I’ll keep an eye on two tracks: FDA labels, which control what’s on-label and stocked under standing orders, and ACIP recommendations, which mostly affect coverage and messaging. Unless FDA changes course or ACIP takes an unusually broad stance, access for healthy under-65s will stay constrained. Plan based on that reality, and I’ll update this post if the CDC news develops further or if any guidance changes that might affect your options.