FDA Approves Updated COVID-19 Vaccines Targeting XFG Variant for 2026-27 Season

The US Food and Drug Administration approved updated COVID-19 vaccines on Thursday, allowing manufacturers to begin shipping doses to pharmacies and doctors’ offices across the country. The FDA cleared vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech after an advisory panel recommended that the shots should target the dominant XFG variant, also known as Stratus. All manufacturers previously said they could make the updated shot in time for the 2026-27 immunization season.

The vaccines receive approval for individuals aged 65 and older, and for younger individuals with underlying conditions that put them at greater risk of negative outcomes from a COVID infection. For younger people with such conditions, the age approvals vary by manufacturer – the Moderna shot receives approval for children older than six months, the Pfizer-BioNTech vaccine for those aged five and older, and Novavax-Sanofi for 12 and up.

“This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days,” the companies said.

Multiple Vaccine Options for Different Age Groups

Moderna offers two vaccine options for the upcoming season – mNEXSPIKE and Spikevax. The Spikevax vaccine receives approval for people aged six months through 64 who have an underlying condition, and anyone aged 65 or older. The mNEXSPIKE vaccine receives approval for people aged 12 through 64 who have an underlying condition, and anyone aged 65 or older. Both mRNA-based vaccines target the XFG subvariant of the JN.1 coronavirus strain.

The Pfizer-BioNTech vaccine, called COMIRNATY XFG, receives approval for all adults aged 65 and older and people aged 5 through 64 who have a condition that raises their risk of severe illness. The company states its vaccine targets the LP.8.1 strain of the coronavirus, though it also addresses the XFG variant according to FDA recommendations.

Novavax-Sanofi provides the only protein-based COVID vaccine available in the US, called Nuvaxovid. The vaccine receives approval for everyone aged 65 and older and for those aged 12 through 64 who have underlying conditions. This vaccine targets the JN.1 strain.

Trump Administration Changes Vaccine Recommendations

Last fall, the Trump administration moved away from recommending COVID vaccines to everyone, prompting confusion over who was eligible to receive the shots. The Centers for Disease Control and Prevention now says it recommends the immunizations “based on individual-based decision making”. The administration had shelved the universal COVID vaccine recommendation and now recommends that everyone aged six months and older consult a healthcare provider before getting the shot.

It remains unclear when, or whether, the administration will issue updated recommendations for the 2026-27 immunization season, as the CDC advisory panel has been in limbo since a March ruling blocking health secretary Robert F Kennedy Jr’s appointment of a slate of vaccine advisors to the panel. The absence of a functioning CDC vaccine panel also raises questions over whether insurers will cover the updated shots.

Insurance Coverage Uncertainty Looms

Insurers typically face requirements to cover vaccines recommended by the CDC advisory panel, but it remains unclear what insurers will do if there is no recommendation. The CDC has yet to make an official recommendation for this year’s vaccines. Experts say the vaccines should begin reaching pharmacies and doctors’ offices in September, providing time for distribution before the fall respiratory illness season begins.

In May, eight of the committee’s nine experts voted in favor of targeting the XFG variant for the 2026-27 campaign. For the 2025-26 season, the FDA had recommended that COVID shots target LP.8.1, a subvariant of the JN.1 strain.

Understanding the XFG Variant

The XFG variant, more commonly known as Stratus, represents the latest mutation that began gaining momentum last year. Stratus shows “marginal additional immune evasion” over the previous dominant strain known as Nimbus, according to the World Health Organization, meaning it has developed a slightly better ability to avoid being recognized and attacked by the immune system.

The Pfizer/BioNTech COMIRNATY vaccine “continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as clinical, non-clinical, pharmacovigilance, and manufacturing data,” its makers said. The latest version arrives as COVID-19 now stands mainly regarded as a common respiratory ailment rather than the all-out emergency it presented in 2020 and 2021.

Current COVID-19 Activity Levels in the United States

CDC dashboards show current COVID-19 activity level tracked via testing, and wastewater monitoring remains low, but rising in recent weeks. The Centers for Disease Control and Prevention assessed last week that the amount of acute respiratory illness causing people to seek treatment stands at “very low” levels, while national and regional COVID-19 activity shows increases. Doctors have been reporting an increase in patients testing positive through the summer.

“CDC has observed a trend of declining COVID-19 hospitalizations nationally over time,” the agency said. “However, it remains possible that there could be larger increases this summer, particularly if a variant that the immune system no longer recognizes becomes more common.”

The health officials’ scenario modeling indicates that regions which did not experience a substantial level of COVID-19 activity during the most recent winter months – namely the US South and West – face expectations to experience increases in COVID-19 activity as fall approaches. Some physicians report noticing a change in how the illness presents itself, with reports emerging stating that COVID resurfaces with new symptoms including nausea and other gastrointestinal issues.