Moderna's about-face, a vote recommending OTC naloxone, & can food be medicine?

Moderna is making a course correction, ensuring Americans have access to its Covid vaccine whether they have insurance coverage or not.

February 16, 2023 Check out STAT+

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By Elizabeth Cooney Reporter, Morning Rounds Writer

Good morning. Nick Florko has food for thought for us today: Can it be medicine?

vaccines Moderna says Americans won't have to pay for its Covid-19 vaccine after all When Moderna announced initial plans to charge $110 to $130 per Covid vaccine dose after its government contracts expire, the blowback was swift. Now the biotech company is making a course correction, ensuring Americans have access to its shots whether they have insurance coverage or not. "Everyone in the U.S. will have access to Moderna's Covid-19 vaccine regardless of their ability to pay," the company said in a statement yesterday. The about-face came on the same day that Sen. Bernie Sanders (I-Vt.), who chairs the Senate Committee on Health, Education, Labor, and Pensions, accused the company of "corporate greed," STAT's Ed Silverman and Sarah Owermohle write. "None of them were billionaires before the taxpayers of our country funded the research and development for the Covid-19 vaccine," Sanders said about Moderna executives in remarks on the Senate floor. Read more about the lawsuits over vaccine patents and controversies over access. addiction FDA panel favors OTC naloxone for opioid overdoses In a unanimous vote yesterday, FDA advisers recommended that naloxone nasal spray, the medication commonly used by first responders and others to reverse opioid overdoses, be available over the counter. Commonly known as Narcan, it's sold as a general intramuscular injection, a nasal spray, and a mechanized auto-injector. The panel's debate centered on the medication's safety and whether non-health care professionals could follow instructions in Narcan's packaging well enough to effectively administer it in an emergency. In the end, the urgency of the U.S. overdose crisis won out, far outweighing the potential delays associated with gathering new data and running user-friendliness tests on new instructions. Two manufacturers are applying for non-prescription status: Emergent BioSolutions and Harm Reduction Therapeutics, a nonprofit organization. The FDA is likely to issue an approval decision within months. STAT's Lev Facher has more. cancer Older breast cancer patients might be able to skip radiation, study says The regimen is familiar: First comes a diagnosis of breast cancer, after which surgery removes small, low-risk tumors, followed by radiation and then a five-year course of hormonal therapy to lessen the chances of recurrence. Cancer specialists have begun to question whether radiation is necessary, given its potential for troubling side effects, especially in older women. Until recently, most research has excluded women over 65.  A new NEJM study suggests that many older patients could skip radiation after surgery without shortening their overall survival. More than 1,300 women 65 or older who had hormone receptor positive tumors 3 centimeters wide or less were split into two groups. Half got radiation, half didn't, but overall survival was 80% in both groups. There were differences, though, in whether the cancer returned in the same breast depending on radiation choice, how weak hormone receptors were, or length of hormone therapy. STAT's Angus Chen explains.

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Closer Look Can food be medicine? And will insurance cover it? Molly Ferguson for STAT It makes such intuitive sense, it's a wonder it's never really caught on. Good food is good for us, so shouldn't food also be medicine? Well, even though the concept might be having a moment now, STAT's Nicholas Florko points out two reasons why it hasn't gained traction over the years: There's a paucity of solid research showing which conditions improve with food, and there are plenty of regulatory requirements keeping some insurers from offering some version of  "food prescriptions" to their members. But we may be at an inflection point, following a nutrition conference and a national nutrition strategy released by the White House in September. "There's just this whole new energy and whole new focus on this topic — which gives me great hope that we will make progress," Rep. Jim McGovern (D-Mass.) told Nick. "I've never felt more hopeful that we are going to make progress than I am right now." Read more. infectious disease Mpox still a global health emergency, WHO says The WHO announced yesterday that the mpox outbreak remains a global health emergency. Though transmission has slowed considerably since its apex last summer, STAT's Helen Branswell tells us, a committee of outside experts that met last week recommended the WHO keep the mpox public health emergency of international concern in place to sustain attention on the problem and to encourage countries to maintain surveillance. The committee expressed concern that cases are likely being missed in some circumstances, and detected but not reported in others. "WHO continues to call on all countries to maintain surveillance for mpox and to integrate services for prevention, preparedness, and response into national control programs, including for HIV and other sexually transmitted infections," Director-General Tedros Adhanom Ghebreyesus said in announcing he had accepted the emergency committee's advice. Since the outbreak was first detected, 110 countries have reported nearly 86,000 cases, 93 of them fatal. coronavirus Long Covid's long reach  Long Covid by almost any measure is a heavy burden. Here are three ways: Writing in a STAT First Opinion, critical care physician Wes Ely recounts how brain fog torments two patients: a woman diagnosed at 59 with rapid onset dementia post-infection and a 26-year-old man incapacitated by the mildest exertion. "At work my brain is just begging for rest," he said. People with long Covid are less likely to be employed full-time and more likely to be unemployed, especially if they have cognitive symptoms, a  JAMA Network Open study reported yesterday. After three months, 1 in 8 patients infected with Covid had severe, prolonged fatigue, a study in Clinical Infectious Disease found. Incidence is declining and vaccination reduces the risk across variants, study author Michael Gottlieb of Rush University Medical Center said during an IDSA media briefing yesterday, "but because so many people have gotten Covid, there's still a huge number of people who are suffering from prolonged symptoms." by the numbers

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What we're reading What not to ask me about my long Covid, The Atlantic How a pioneering diabetes drug offers hope for preventing autoimmune disorders, Nature Zantac's maker kept quiet about cancer risks for 40 years, Bloomberg  How do pandemics begin? There's a new theory — and a new strategy to thwart them, NPR Opinion: Cutting Medicaid after the pandemic would be political madness, STAT

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Thanks for reading! More tomorrow,

elizabeth.cooney@statnews.com

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