FDA Approves Four Updated COVID-19 Vaccines, But CDC Still Hasn't Said Who Should Get One

The FDA approved four updated COVID-19 vaccines on Thursday, August 27, clearing shots from Pfizer-BioNTech, two versions from Moderna, and a non-mRNA option from Novavax-Sanofi for the 2026-2027 season. All four target the XFG variant, a subvariant of JN.1 that the CDC says drove most infections last season.

Pfizer and BioNTech's Comirnaty is approved for adults 65 and older and people ages 5 to 64 with an underlying condition. Moderna's Spikevax got approval for ages 6 months to 64 with a risk condition, plus everyone 65 and up. Moderna's lower-dose mNexspike is cleared for ages 12 to 64 with a condition, and 65-plus. Novavax and Sanofi's Nuvaxovid, the only non-mRNA option, is approved for ages 12 to 64 with a condition and everyone 65 and older, according to MedPage Today and confirmed by the companies' own announcements.

None of the shots are approved for healthy people under 65 without a qualifying condition. Conditions that count include asthma, diabetes, obesity, heart and kidney disease, and pregnancy, per the CDC's list cited by CIDRAP.

Shots are shipping. Guidance isn't.

Pfizer says it's already distributing vaccine and expects pharmacy availability within days. Moderna says its shots will arrive "in the coming days." That's the easy part.

The hard part: the CDC hasn't issued a recommendation for this season at all. Its Advisory Committee on Immunization Practices, the panel that normally tells doctors and insurers who should get a vaccine, has been in legal limbo since a March ruling blocked Health Secretary Robert F. Kennedy Jr.'s appointment of new advisers, according to The Guardian. The panel skipped its regular March and June meetings this year, MedPage Today reported.

This is significant. Insurers are typically required to cover vaccines the ACIP recommends. With no meeting and no vote, there's no fresh recommendation to point to. AHIP, the industry group representing most health insurers, has said members will cover the cost of vaccines recommended by a CDC committee through the end of 2027, but that promise is only as good as a recommendation that doesn't currently exist for this season.

Last fall, under Kennedy, the administration moved away from a universal vaccine recommendation to a model the CDC calls "individual-based decision-making" — essentially, talk to your doctor. Medical groups have stepped into the vacuum instead. The Infectious Diseases Society of America, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians have all issued their own guidance, MedPage Today reported. The American College of Physicians recommends the shot for everyone 65-plus and higher-risk adults 18 to 64, and says average-risk adults under 65 "may consider" it. The American Academy of Pediatrics won't release its 2026-2027 recommendations until September.

The mRNA fight underneath it all

Kennedy has been an outspoken critic of mRNA vaccines for respiratory illness, saying they don't work well, as noted by The Epoch Times. That skepticism shows up in the fine print of these approvals. The FDA released Pfizer, Moderna, and Novavax from a prior requirement to run new placebo-controlled trials, citing "operational and feasibility challenges." Instead, it's letting manufacturers run single-arm studies. FDA officials said as recently as 2025 that placebo-controlled trials were "imperative" given how many years it's been since the shots were tested that way, according to The Epoch Times' review of FDA documents. Pfizer, Moderna, and Novavax have still committed to eventually running those trials.

This raises a legitimate point for critics. If regulators themselves said fresh placebo-controlled data was necessary, and then waived that requirement for "feasibility" reasons, patients are being asked to trust real-world and prior clinical data rather than a rigorous head-to-head test against no vaccine at all. Whether that's a reasonable tradeoff for a rapidly mutating virus or a shortcut that undercuts public confidence is a fair question the FDA hasn't fully answered. The agency didn't even issue a formal press release announcing the approvals, breaking from past practice, and HHS didn't respond to requests for comment, per The Epoch Times.

Meanwhile the CDC's own numbers show test positivity approaching 5% for the week ending August 15, the highest since early February, with cases climbing in every state, according to CNN. CIDRAP reported cases are "growing or likely growing" in 48 states. The virus isn't waiting for the paperwork.

What happens next

The immediate question is whether the CDC's ACIP panel meets before flu season peaks, and whether it issues any recommendation at all for 2026-2027. Until it does, coverage decisions sit with individual insurers and doctors rather than a uniform federal standard. The AAP's pediatric guidance, due in September, will be the next concrete marker to watch. Last season the group recommended vaccination for all infants and children, a stance that may or may not survive the broader shift toward individualized decision-making.