The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Moderna, Pfizer-BioNTech, and Novavax-Sanofi, clearing the way for doses to begin shipping to pharmacies and doctors’ offices. The approvals, announced by the companies on Thursday, follow an advisory panel recommendation that the shots target the dominant XFG variant.

Eligibility and Variant Targeting

All three vaccines are approved for individuals 65 and older, as well as younger people with underlying conditions that increase their risk of severe illness. For younger individuals, age thresholds vary by manufacturer: Moderna's shot is approved for children older than six months, Pfizer-BioNTech's for those five and older, and Novavax-Sanofi's for those 12 and up.

According to a report from CNN, Moderna's Spikevax targets the XFG subvariant of the JN.1 coronavirus strain, while its second formulation, mNexspike, is also approved for the same age groups. Pfizer-BioNTech's vaccine targets the LP.8.1 strain, and Novavax's Nuvaxovid, the only protein-based COVID-19 vaccine available in the U.S., targets the JN.1 strain.

Health conditions that may raise the risk of severe illness include asthma, heart, kidney, liver or lung disease, diabetes, obesity, and pregnancy, according to the Centers for Disease Control and Prevention (CDC).

The Guardian reported that manufacturers previously said they could produce the updated shots in time for the 2026-27 immunization season.

CDC Recommendation and Advisory Panel Uncertainty

The CDC has not yet issued an official recommendation for this year's vaccines, reflecting a shift under the Trump administration from a universal recommendation to a more restricted approach. The agency now recommends immunizations "based on individual-based decision making," and it remains unclear when or whether the administration will issue updated guidance for the 2026-27 season.

A key complication is the status of the CDC's advisory panel, which has been in limbo since a March ruling blocked Health Secretary Robert F. Kennedy Jr.'s appointment of a slate of vaccine advisors. The absence of a functioning panel raises questions about insurance coverage, as insurers are typically required to cover vaccines recommended by the panel. Without a recommendation, it is unclear what insurers will do.

Current COVID-19 Activity

According to CDC dashboards, current COVID-19 activity—tracked via testing and wastewater monitoring—is low but rising in recent weeks. Experts say the vaccines should begin appearing in pharmacies and doctors' offices in September.

Broader Context: mRNA Flu Vaccine Approval

The FDA has also recently approved Moderna's mRNA-based flu vaccine, mFLUSIVA (mRNA-1010), for adults ages 50 and older. This is the first mRNA-based flu vaccine, using technology similar to the mRNA COVID-19 vaccines. The approval was based on a phase 3 trial involving more than 40,000 adults across 11 countries, which showed the vaccine was superior to a standard-dose licensed flu vaccine in preventing RT-PCR-confirmed flu-like illness.

Moderna expects mFLUSIVA to be available in the U.S. for the 2026-2027 respiratory virus season. Experts advise that while the mRNA flu vaccine provides an additional option, it is not a replacement for existing flu vaccines. The CDC estimates there were 45,000 flu-related deaths in the 2024-2025 flu season, with vaccination preventing around 12,000 deaths.