Authorization covers seniors 65+ and high-risk patients ages 5 to 64

The U.S. Food and Drug Administration has approved Pfizer and BioNTech’s updated COVID-19 vaccine formula for the 2026-2027 season, the companies said Thursday. The mRNA vaccine, called COMIRNATY XFG, targets the XFG variant of the virus.

The authorization covers adults ages 65 and older and people ages 5 through 64 who have at least one underlying condition that places them at high risk for severe outcomes from COVID-19, according to the drugmakers.

The companies said the updated vaccine “will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.” Pfizer and BioNTech described the COMIRNATY vaccine as continuing to “demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as clinical, non-clinical, pharmacovigilance, and manufacturing data.”

The XFG variant, more commonly known as Stratus, became the dominant mutation last year. The World Health Organization said Stratus shows “marginal additional immune evasion” over the previously dominant variant, known as Nimbus — meaning it has developed a slightly better ability to avoid being recognized and attacked by the immune system.

The release comes as COVID-19 has come to be regarded as a common respiratory illness rather than the all-out public health emergency it was in 2020 and 2021. The Centers for Disease Control and Prevention said last week that the amount of acute respiratory illness causing people to seek treatment is “very low,” while national and regional COVID-19 activity is increasing.

The CDC also said it has “observed a trend of declining COVID-19 hospitalizations nationally over time,” but added that “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.”

CDC scenario modeling indicates that regions which did not experience substantial COVID-19 activity during the most recent winter months — particularly the U.S. South and West — are expected to see increases in COVID-19 activity as fall approaches.