FDA Approves XFG COVID-19 Vaccines Without a CDC Vote

The Food and Drug Administration approved four updated COVID-19 vaccines targeting the XFG variant on August 27, clearing them for U.S. shipment. Pfizer and BioNTech said Comirnaty would begin moving that day, and Moderna said Spikevax and mNEXSPIKE would follow in the coming days.

The licenses land without a CDC advisory vote on who should get the new formula this season. Last year’s narrower labels still apply, and the panel that usually writes the fall recommendation remains frozen in court.

Four XFG Shots Can Ship

The products are Moderna’s Spikevax and mNEXSPIKE, Pfizer and BioNTech’s Comirnaty, and Nuvaxovid, the protein shot from Novavax that Sanofi commercializes in the United States. All four are built as a monovalent JN.1 lineage XFG variant vaccine, the composition the FDA told manufacturers to use after its May meeting.

On May 28, the Vaccines and Related Biological Products Advisory Committee voted 8 to 0, with one abstention, for that XFG target. Last season’s U.S. shots were aimed at LP.8.1, another JN.1 descendant that had already faded in U.S. sequences by the time the committee met.

Pfizer said the XFG-adapted Comirnaty generated immune responses against XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other current lineages, and that it would begin shipping immediately to pharmacies, hospitals, and clinics. The companies put more than five billion Comirnaty doses as having been distributed worldwide across the product’s life.

Moderna’s own notice went out the same afternoon. Spikevax’s 2026-27 formula already had approvals in Europe, South Korea, Singapore, Switzerland, and the United Kingdom. mNEXSPIKE’s matching formula had a nod in Japan.

Today we announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Applications for the 2026-2027 formulas for Spikevax® (COVID-19 Vaccine, mRNA) and mNEXSPIKE® (COVID-19 Vaccine, mRNA), containing the JN.1-lineage XFG subvariant of… pic.twitter.com/Ydu7Dmef3P

— Moderna (@moderna_tx) August 27, 2026

Stéphane Bancel, Moderna’s chief executive, tied the update to last year’s caseload rather than to a new universal campaign.

COVID-19 remains a serious public health threat, responsible for up to 2.3 million outpatient visits and 250,000 hospitalizations in the U.S. last year alone. Our updated COVID-19 vaccines help protect those at high risk of severe disease, and we are proud to help ensure Americans have access to the latest protection against currently circulating SARS-CoV-2 strains this respiratory virus season.

Stéphane Bancel, Chief Executive Officer, Moderna

Nuvaxovid is the only non-mRNA option in the set. John C. Jacobs, Novavax’s president and chief executive, said Sanofi had expanded U.S. marketing and that Takeda, the Japan partner, had already made Nuvaxovid the second-leading COVID-19 vaccine in that market. Novavax now collects royalties instead of running its own U.S. sales force.

Who Can Get the 2026-27 COVID Vaccine?

Every label keeps last year’s age and risk limits. Adults 65 and older are in for all four shots. Younger people are in only if they have at least one condition that raises the chance of severe COVID-19, and the floor age still depends on the brand.

THE FOUR APPROVED SHOTS

That split leaves a protein option for people 12 and older who do not want mRNA, and it leaves no licensed protein COVID-19 vaccine for children under 12. Spikevax is the only product that starts at 6 months, and only when the child has a listed risk factor. Healthy people under 65 are outside every label.

CDC materials still list the kinds of conditions that put someone in the higher-risk group, and they still let a person attest to those factors at the counter.

HIGH-RISK CONDITIONS CDC FLAGS

• Breathing and heart: Asthma and other chronic lung disease, plus heart disease, sit on the agency’s risk list.
• Metabolic and organ disease: Diabetes, obesity, and chronic kidney or liver disease are treated as reasons the benefit of a dose is higher.
• Pregnancy: Pregnancy is listed because it raises the chance of severe illness compared with people who are not pregnant.
• Self-attestation: People may attest to those factors during the decision and get a dose where shots are offered, without bringing records that prove the diagnosis.

The same CDC pages still describe vaccination based on individual-based decision-making, also called shared clinical decision-making, for people 6 months and older. That language dates to the 2025-26 schedule. It is not a new 2026-27 recommendation for the XFG formula, because the committee that would write one has not met.

A Court Order Left ACIP Empty

The Advisory Committee on Immunization Practices is the CDC panel whose votes usually set the immunization schedule and, through federal law, no-copay coverage. It has not held its regular March or June sessions this year.

On March 16, Judge Brian E. Murphy of the U.S. District Court for the District of Massachusetts stayed Health Secretary Robert F. Kennedy Jr.’s reconstitution of the panel and froze the votes that panel had taken. Kennedy had dismissed the 17 sitting members in 2025 and installed new ones. Murphy found those appointments likely unlawful under the Federal Advisory Committee Act and said a committee of non-experts could not claim the balance the rules require.

This is all to say that there is a method to how these decisions historically have been made, a method scientific in nature and codified into law through procedural requirements. Unfortunately, the Government has disregarded those methods and thereby undermined the integrity of its actions.

Judge Brian E. Murphy, U.S. District Court for the District of Massachusetts

The stay also paused a January CDC memo that had cut the childhood schedule from 17 routine recommendations to 11. The government appealed to the First Circuit on April 29 and later asked that court to move faster, arguing the panel lacked a quorum for seasonal flu advice and that reformulated respiratory vaccines could not be added to the schedule while ACIP cannot act.

HOW THE PANEL GOT STUCK

1. October 6, 2025: CDC adopts individual-based decision-making for COVID-19 vaccination on the adult and child schedules.
2. March 16, 2026: Murphy stays Kennedy’s ACIP appointments, the panel’s prior votes, and the January childhood-schedule cut.
3. May 28, 2026: FDA’s separate vaccine committee, VRBPAC, votes 8 to 0 with one abstention for an XFG monovalent formula.
4. August 27, 2026: FDA approves the four updated COVID-19 vaccines. CDC still has issued no new seasonal ACIP recommendation.

Dr. William Schaffner, an infectious disease physician at Vanderbilt University and a longtime ACIP adviser, warned in the spring that newly licensed vaccines and new indications, while legal to prescribe, may not be covered by insurers or placed in federal programs without an ACIP recommendation. That warning still fits the week these four licenses landed.

Coverage Now Rests on an Insurer Pledge

Under the Affordable Care Act, plans generally must cover ACIP-recommended vaccines with no patient cost-sharing. No new ACIP vote on the 2026-27 COVID-19 formula means that statutory hook does not clearly attach to this season’s XFG products on its own.

America’s Health Insurance Plans, the trade group for many commercial insurers, tried to paper over that hole last year and then extended the promise. A statement updated in May says member plans will keep covering ACIP-recommended immunizations with no cost-sharing through the end of 2027.

The original September 2025 version of that pledge named vaccines recommended as of September 1, 2025, “including updated formulations of the COVID-19 and influenza vaccines.” The May refresh dropped the freeze date and kept the no-copay promise through 2027. That is a voluntary floor, not a new federal mandate, and it does not bind every self-insured employer plan the same way.

Pharmacies can still stock a licensed shot. A clinician can still give it to someone who matches the label. What a given patient pays will turn on plan documents, Medicaid and Vaccines for Children rules that also track ACIP, and whether the insurer treats the XFG formula as last year’s COVID-19 vaccine in a new vial.

XFG Still Leads in Sequenced Wastewater

XFG was the dominant U.S. SARS-CoV-2 strain across the 2025-26 season. Moderna’s briefing to VRBPAC put the broader JN.1 family at more than 80% of sequences collected from May 1, 2025, through April 30, 2026, and said 66% of that family was XFG, with LP.8.1 under 1%.

The picture in late August is messier, and the two public trackers do not agree on how large the wave is. CDC dashboards have described national COVID-19 activity as low, though rising, and the agency has said new clinical strain shares are thin because sequencing submissions are down. WastewaterSCAN, a university-run sewage network, rated national SARS-CoV-2 high in its August 20 update, with levels up across three weeks and, at some sites, above last winter.

WASTEWATERSCAN, WEEK OF AUGUST 15

• XFG share: 50.8% of sequenced virus in the subset of sites that reported lineage data, with a one-to-two-week lag after collection.
• LF.7 share: 12.1% in that same slice.
• BA.3.2 share: 11.8%, a lineage genetically apart from the JN.1 family that includes XFG.
• The rest: Other lineages make up the remaining 25.3% of that sequenced sample.

Those figures are not a national clinical case mix, and they should not be read as a CDC Nowcast. They do show why VRBPAC picked XFG in May and why a shot aimed at LP.8.1 would have been a year late. They also show the virus has not stood still: XFG.1.1, sometimes called Stratus, and NB.1.8.1, sometimes called Nimbus, have been part of the same wave, which is why Pfizer listed both in its immune-response package.

Medical Groups Issued Their Own Fall Advice

With ACIP silent, specialty societies have been writing the practical advice that clinics will actually use. The Infectious Diseases Society of America, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have put out fall respiratory-virus guidance that includes COVID-19 shots. The American College of Physicians recommends COVID-19 vaccination for everyone 65 or older and for people 18 to 64 at increased risk of severe disease, a tighter adult frame than the CDC’s still-posted individual-decision language for all ages 6 months and up.

That patchwork is the working substitute for a June ACIP meeting that never happened. It does not restore a universal recommendation. It does give a physician, pharmacist, or midwife something current to stand on when a 70-year-old, a pregnant patient, or a 40-year-old with diabetes asks whether the new vial is for them.

The strain change itself is the same kind of annual update used since COVID-19 shots became seasonal. FDA cleared the new formula on the accumulated safety file plus manufacturing and immunogenicity data for the XFG spike, not on a fresh large outcomes trial in humans. That is how flu strain switches are licensed too, and it is also the opening critics used this week when they argued the human evidence for this exact vial is thin. The license does not settle that argument. It only makes the product legal to ship.

The First Circuit Hears the Case in October

Georgetown’s health-litigation tracker, updated the day of the FDA approvals, still lists briefing as ongoing in American Academy of Pediatrics v. Kennedy, with oral argument set for October 6 at the First Circuit. Until that court rules, or until HHS rebuilds a panel that satisfies the district court, ACIP cannot vote the XFG shots onto the schedule the way it would in a normal fall.

Doses can still show up in refrigerators this month. The people the labels cover can still get one if they can find a provider and a payer who treat the new formula as this year’s COVID-19 vaccine. What they will not get, before the appeals court sits, is the usual federal sentence that says the shot is recommended, for these groups, for this season.

Disclaimer: This article is news reporting and analysis of FDA licenses, CDC materials, court filings, and company statements. It is informational only and is not medical advice, a vaccination recommendation, or a coverage determination for any person. Readers should talk with a licensed clinician about whether a COVID-19 vaccine is appropriate for their age, health history, and pregnancy status, and should confirm cost-sharing with their insurer or benefits administrator before they book a dose. Figures, labels, court status, and payer pledges reflect the cited sources as of September 2, 2026, and may change as CDC, ACIP, the First Circuit, or health plans issue new decisions.