On Thursday, August 27, 2026, the FDA announced approval of four updated COVID-19 vaccines for the 2026-2027 season: Comirnaty from Pfizer-BioNTech, Spikevax and mNEXSPIKE from Moderna, and Nuvaxovid from Novavax. All four are formulated against the XFG variant, a descendant of the JN.1 lineage, following the recommendation the FDA's vaccine advisory committee made in May. As in the past season, the approvals are limited: all adults 65 and older, and younger people with at least one underlying condition that raises their risk of severe COVID-19, with the minimum age varying by product.
For a practice that stocks vaccines, the news that the FDA has approved the 2026-2027 COVID-19 vaccines lands at the same time as flu season setup and the back-to-school rush, and it brings a set of tasks that are not clinical. Who is eligible has to be screened at scheduling. The product codes have to be loaded. CMS will post payment allowances for the new products, and until they appear the charge master carries last season's. Administration billing changed in January with the revised 90480 and the new 90481, and staff who learned the old way will bill it wrong.
This is the setup list we are working through with the practices we bill for this week, in the order we do it.
Key takeaways
- Four updated COVID-19 vaccines were approved August 27, 2026 for adults 65 and older and for younger people with qualifying risk conditions; the minimum age is 6 months for Spikevax, 5 years for Comirnaty and 12 years for mNEXSPIKE and Nuvaxovid.
- Eligibility is narrower than in the pre-2025 seasons, so the front desk needs a screening question and the clinical team needs a list of qualifying conditions.
- Each product has its own CPT code; CMS posts Medicare Part B payment allowances for the new formulations on its vaccine pricing page and updates the file as prices arrive.
- Administration is reported with CPT 90480 for the first or only component and 90481 for each additional component, with M0201 for in-home administration.
- Medicare Part B pays for the vaccine and administration with no cost sharing; commercial coverage for patients outside the approved groups is uncertain and should be verified.
The 2026-2027 COVID-19 vaccines: what was approved and for whom
| Product (manufacturer) | Type | Approved population, 2026-2027 |
|---|---|---|
| Comirnaty (Pfizer-BioNTech) | mRNA | Ages 5 and older with at least one high-risk condition; all adults 65 and older |
| Spikevax (Moderna) | mRNA | Ages 6 months and older with at least one high-risk condition; all adults 65 and older |
| mNEXSPIKE (Moderna) | mRNA, lower dose | Ages 12 and older with at least one high-risk condition; all adults 65 and older |
| Nuvaxovid (Novavax) | Protein subunit, adjuvanted | Ages 12 and older with at least one high-risk condition; all adults 65 and older |
The population limits continue the approach the FDA adopted in 2025, when it moved away from approving updated COVID-19 vaccines for everyone 6 months and older. Whether the CDC's immunization schedule and its Advisory Committee on Immunization Practices align with the FDA labels for this season is a separate question that we expect to be answered in September; practices should watch for the CDC's recommendation, because payer coverage under the ACA preventive rules follows the CDC schedule, not the FDA label alone. Until then, the FDA-approved population is the safe planning basis.
The list of qualifying underlying conditions is long and is maintained by the CDC; it includes, among many others, diabetes, chronic kidney disease, chronic lung disease, heart conditions, obesity, immunocompromise, pregnancy, and mental health conditions such as depression. Most adults over 50 have at least one. That matters for the front desk conversation, which we get to below.
Eligibility screening at scheduling and check-in
A narrower label means the practice has to ask a question it did not ask in 2022. For patients 65 and older, nothing changes: they are eligible for every product. For patients under 65, the scheduler or the rooming staff needs to establish that at least one qualifying condition exists, and the clinician needs to document it. In practice the simplest approach is a one-line prompt in the vaccine order: "Age 65 or older, or qualifying condition: ____." The condition's diagnosis code goes on the claim alongside Z23 (encounter for immunization), which both supports the vaccination and helps if a payer later questions eligibility.
Patients under 65 without a listed condition who want the vaccine are the difficult group. The FDA label does not cover them, and while a clinician may still vaccinate off label, payer coverage is not assured. Our advice is that the front desk should not promise coverage to anyone under 65 without checking, and that practices should decide in advance whether they will offer the vaccine off label at a self-pay price, and what that price is. Deciding this at the counter on the first busy Saturday is how complaints happen.
Product codes and CMS pricing
Each COVID-19 vaccine product has its own CPT code in the 91300 series, and the updated formulations for the 2026-2027 season are reported with the codes assigned to the current products and dosages (for example 91320 for the Comirnaty 30 mcg adult presentation, 91322 for Spikevax 50 mcg, 91323 for mNEXSPIKE, 91304 for Nuvaxovid). The AMA publishes vaccine code updates outside the annual CPT cycle when formulations change, so check the AMA's COVID-19 vaccine code list against the packaging when the product arrives rather than assuming last year's code carries over.
Medicare Part B covers COVID-19 vaccines and their administration with no deductible or coinsurance. CMS prices the products on its vaccine pricing page, in the same 2026-2027 seasonal influenza and COVID-19 vaccine pricing file that carries the flu allowances posted July 31, and it updates that file as manufacturers report prices for the new formulations; the file will show an effective date for each new product, and our expectation is that the COVID-19 lines will carry the August 27 approval date. Load the allowances when they appear and make sure the charge for each product is above the allowance. A charge master still carrying the 2025-2026 figures pays you the 2025-2026 figure if the charge is lower than the new allowance.
Commercial payers and Medicaid programs price vaccines their own way, and for patients under 19 the Vaccines for Children program supplies the product. The eligibility check tells you which; the plan's policy tells you the codes.
Administration: 90480 and 90481
This is the part where we expect the most errors this fall, because the codes changed in January. For 2026, CPT revised 90480 to describe administration of the first or only component of a vaccine, replacing the earlier single-dose language, and added 90481 for each additional component. For a standard COVID-19 vaccine, the administration is 90480, one unit. The revision was written with combination vaccines in mind, and the AMA's guidance on when 90481 applies should be read before anyone reports it. For Medicare, the payment allowance for 90480 is on the physician fee schedule and is not adjusted for the vaccine type; when the vaccine is given in the patient's home and no other Medicare service is provided at the visit, add M0201 for the in-home administration payment.
Do not report 90471 or 90472 for a COVID-19 vaccine; those are the general vaccine administration codes and payers reject them for COVID-19 products. Do not report an E/M for a visit whose only purpose was the vaccine. If the patient receives a flu vaccine at the same visit, the flu administration is separate: G0008 for Medicare, 90471 or 90472 for commercial payers.
Coverage questions the front desk will get
Three questions will come up at the desk. "Am I eligible?" The answer is the age and condition rule above, and staff should have the CDC condition list at hand. "Is it free?" For Medicare patients, yes, for Part B vaccines given in network. For commercial patients in the approved groups, most plans cover it under the preventive benefit with no cost share once the CDC recommendation is in place; before that, verify. For patients outside the approved groups, the honest answer is that coverage is uncertain and the practice offers a self-pay option, if it does. "Can I get it at the pharmacy instead?" Yes, and for many patients that is easier; the practice's job is to document the vaccine in the record when the patient reports it, and to reconcile with the state immunization registry.
Write those three answers on a card for the desk. The vaccine conversation should take thirty seconds, and it takes five minutes when staff are guessing.
Questions we hear
Can we vaccinate a 45-year-old with no risk conditions who asks for the vaccine?
That is a clinical decision for the physician, and off-label use of an approved vaccine is legal. The billing point is that payer coverage is not assured, so the patient should be told before the dose that they may be responsible for the cost and, for a commercial plan, the practice should verify or use a waiver. For a Medicare patient this question does not arise, because everyone 65 and older is in the approved population.
We still have doses of last season's formulation. Can we use them?
The prior season's products are no longer the approved formulation once the updated vaccines are licensed, and manufacturers and the CDC generally direct that remaining older doses not be administered. Follow your state health department's and the manufacturer's disposal or return instructions, and do not bill for a dose of a superseded formulation.
How do we document eligibility for a patient under 65?
Record the qualifying condition in the note and put its diagnosis code on the claim with Z23. A checkbox on the vaccine consent form that lists the condition categories, initialed by the patient and confirmed by the clinician, is enough for most payers and takes ten seconds at rooming.
What to do this week
- Confirm the product codes for each COVID-19 vaccine you have ordered against the AMA's current vaccine code list and the packaging.
- Check the CMS vaccine pricing file for the 2026-2027 COVID-19 allowances and load them, and set charges above the allowances.
- Add the eligibility prompt (65 and older, or qualifying condition) to the vaccine order and the consent form, with the CDC condition list attached.
- Review 90480 and 90481 with the charge entry staff and add a scrubber rule that rejects 90471 on a COVID-19 vaccine line.
- Decide the practice's position on off-label vaccination and the self-pay price, and write the three front-desk answers on a card.
Our medical billing team is loading these codes and allowances for the practices we serve as the file updates, and the vaccine billing module in our RCM training courses covers 90480, 90481 and the Medicare flu codes side by side.
