A cancer vaccine breakthrough, medical AI faces a reality check and recalls pile up

Peer Review

Rehashing the week’s health headlines

💨 Public Health Watch 

Contaminated alfalfa, eye drop recalls and cyclospora

Federal health officials are investigating simultaneous Salmonella and E. coli outbreaks linked to alfalfa sprouts that have sickened at least 55 people across 15 states. Everything Sprouts has recalled certain lots sold under the Everything Sprouts and Calco brands. Sprouts are particularly susceptible to contamination because the warm, humid conditions needed to grow them are also ideal for bacteria.

Meanwhile, nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief have been recalled nationwide because of concerns that the product may not be sterile. The recall involves 15-milliliter bottles from lot 2552A, with an expiration date of Sept. 30, 2027. No adverse events have been reported, and the FDA classified it as a Class II recall, meaning serious harm is considered unlikely. Still, contaminated eye drops deserve particular attention because they’re applied directly to the eye.

The Cyclospora outbreak is still growing. The CDC has now received reports of more than 17,000 confirmed cases since May 1. Missouri surpassed 2,000 reported cases. Additional cases tied to recalled Taylor Farms iceberg lettuce continue to be identified, but the potentially contaminated greens are no longer expected to be available in stores or restaurants.

Bottom line: Check your refrigerator for the recalled alfalfa sprouts and your medicine cabinet for the affected eye drops, and don’t use either if you have them. As for Cyclospora, the growing case count doesn’t mean you need to stop eating lettuce. Many newly reported illnesses occurred weeks ago, and the recalled products have passed their shelf life.

🚩 Reality Check 

The FDA has approved more than 1,300 AI medical devices. Do they actually help patients?

Artificial intelligence is rapidly making its way into hospitals and doctors’ offices, helping physicians analyze X-rays, detect abnormalities and make clinical decisions. The FDA has already cleared or approved more than 1,300 AI-enabled medical devices.

But a new study published in PLOS Digital Health found a striking gap between regulatory authorization and evidence that these technologies actually improve patients’ health.

Researchers examined 1,357 FDA-cleared or approved AI medical devices and found that just 34 — or, 2.5% — had been evaluated in clinical trials. Only 12 had results published in peer-reviewed journals, and just three had been studied using patient-centered outcomes, such as whether the technology reduced deaths, hospitalizations or readmissions.

Bottom line: “FDA-authorized” doesn’t mean an AI medical device is untested or ineffective. But it also doesn’t necessarily mean researchers have shown it makes patients healthier. As medical AI becomes increasingly common, this study suggests the evidence about what happens after tools enter the clinic still has a lot of catching up to do.

🧬 New Development 

A personalized mRNA cancer vaccine just passed a major test

For years, scientists have been trying to create cancer vaccines tailored to the unique mutations inside a patient’s tumor. Last week, that idea cleared a big hurdle.

Merck and Moderna announced their experimental mRNA therapy, called intismeran, successfully reduced the risk that melanoma would return or spread in a Phase 3 clinical trial involving 1,137 patients with high-risk melanoma that had already been surgically removed. Patients received either the personalized vaccine alongside the immunotherapy drug Keytruda or Keytruda alone.

This isn’t a vaccine that healthy people would receive to prevent skin cancer. Researchers first analyze a patient’s tumor for mutations that distinguish the cancer cells from healthy cells. They then manufacture an individualized mRNA treatment designed to teach that patient’s immune system to recognize and attack cells carrying those mutations.

The results are particularly important because smaller, earlier trials had already produced promising findings. In a previous Phase 2 study, adding the personalized vaccine to Keytruda reduced the risk of melanoma returning or death by 49% after five years compared with Keytruda alone. Now the much larger Phase 3 trial has confirmed that the approach can improve recurrence-free survival and reduce the risk of cancer spreading to other parts of the body.

There are still important unknowns. Merck and Moderna haven’t released the full Phase 3 data, including exactly how large the benefit was, and researchers are continuing to follow participants to determine whether the treatment ultimately helps them live longer. The therapy also remains investigational and isn’t yet FDA-approved.

Bottom line: We don’t have a universal “cancer vaccine,” but this is a significant milestone. A personalized vaccine built from an individual patient’s tumor has now succeeded in a large late-stage trial — pushing a decades-old idea considerably closer to becoming a real cancer treatment.

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Get in Touch

That’s all for this week. If you have questions about a health-related story or study you saw in the wild, send me an email at jcraig@san.com or share them below.
— Jess