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Photo: Irfan Khan/Los Angeles Times via Getty Images

Johnson & Johnson announced Thursday that the FDA has authorized an extension of its COVID vaccine's shelf life from three months to 4.5 months.

Why it matters: Amid a slowdown in vaccine uptake, a number of state health officials had been sounding the alarm that hundreds of thousands of single-shot J&J doses could expire this month.

  • Prior to the FDA's extension, which the agency confirmed to Axios, J&J's vaccine could be stored at normal refrigeration temps for up to three months. Pfizer and Moderna's two-shot vaccines must be stored in colder temperatures, but can last for up to six months.
  • The extension is based on "data from ongoing stability assessment studies, which have demonstrated that the vaccine is stable at 4.5 months when refrigerated at temperatures of 36–46°F (2–8°C)," J&J said in a statement.

What they're saying: "A single-shot vaccine that provides protection and prevents hospitalization and death is an important tool in the global fight against COVID-19," J&J said.

  • "Evidence from our Phase 3 ENSEMBLE study demonstrates the efficacy of our single-shot COVID-19 vaccine, including against viral variants that are highly prevalent. Regardless of race and ethnicity, age, geographic location and comorbidities, these results remain consistent."
  • Vaccine providers should check the J&J website to confirm the vaccine's latest expiration dates, the company added.

The big picture: The authorization comes as COVID vaccine demand declines in the U.S., though it continues to skyrocket abroad.

  • In the U.S., over 10.1 million J&J doses have been delivered but not administered, according to CDC data.
  • President Biden has said he will send 20 million doses of COVID vaccines, including Pfizer, Moderna and J&J, to other countries by the end of June.

Go deeper

Tina Reed, author of Vitals
Sep 17, 2021 - Health

Key FDA committee takes on the big booster question

Illustration: Sarah Grillo/Axios

A key FDA advisory committee is meeting today to discuss Pfizer's proposal for a COVID vaccine booster — but it will set the stage for the entire booster debate.

The big question: Not only whether experts believe there’s enough evidence to support boosters, but also whether they believe additional shots should be made available for everyone or limited to older Americans and the immunocompromised.

Sep 17, 2021 - Health

FDA advisory panel recommends Pfizer boosters for those 65 and older

A healthcare worker prepares a dose of the Pfizer-BioNTech Covid-19 vaccine at the Key Biscayne Community Center on Aug. 24, 2021. Photo: Eva Marie Uzcategui/Bloomberg via Getty Images

A key Food and Drug Administration advisory panel on Friday overwhelmingly voted against recommending Pfizer vaccine booster shots for younger Americans, but unanimously recommended approving the third shots for individuals 65 and older, as well as those at high-risk of severe COVID-19.

Why it matters: While the votes are non-binding, and the FDA must still make a final decision, Friday's move pours cold water on the Biden administration's plan to begin administering boosters to most individuals who received the Pfizer vaccine later this month.

Updated 18 hours ago - Politics & Policy

Omicron dashboard

Illustration: Brendan Lynch/Axios

  1. Health: The end of the Omicron wave is in sight — Transplants rebound from COVID lull — Omicron hits American hospitals disproportionately hard
  2. Vaccines: WHO: No evidence that healthy children, teens need boosters — Kids' COVID vaccination rates are particularly low in rural America — Starbucks drops worker vaccine or test requirement after SCOTUS ruling
  3. Politics: Biden concedes U.S. should have done more testing — Arizona says it "will not be intimidated" by Biden on anti-mask school policies— Government website for free COVID tests launches early
  4. World: WHO: COVID health emergency could end this year — Greece imposes vaccine mandate for people 60 and older
  5. Variant tracker