Axios Vitals: Juul generation

Plus, no cuts to Medicare premiums — for now | Tuesday, May 31, 2022

Open in app View in browser   Presented By PhRMA   Axios Vitals By Tina Reed · May 31, 2022 Welcome back from the long weekend, Vitals readers. Today's newsletter is 1,064 words or a 4-minute read. I hope you all had a wonderful — and not too hot — unofficial start to the summer. ☀️ Speaking of which, Axios' Jennifer Kingston reports today about how some cities are getting serious about fighting the dangers of summer heat — even appointing "chief heat officers."     1 big thing: Novavax (finally) prepares for takeoff in the U.S. Illustration: Sarah Grillo/Axios   As one of America's first big bets under Operation Warp Speed, Novavax's COVID vaccine is notably late to the party as the Maryland biotech seeks a potential FDA emergency use authorization for its COVID shot. But company leaders who won $1.6 billion in federal backing early in the pandemic say they now see a clear runway to market success for its protein-based product — not only as a booster for the vaccinated but as an alternative first-line defense for those who've refused mRNA shots. Driving the news: In exactly one week, a key FDA advisory committee will examine Novavax's application for emergency use in adults 18 and older. "While the mRNA vaccines have done a tremendous job in making vaccine available quickly to the U.S. there still remain vaccine-hesitant, there still remain people who would prefer a different vaccine, a protein-based vaccine, and this is in support of that consumer choice," John Trizzino, Novavax chief business officer, told reporters in a recent briefing. The big picture: After early production problems, Novavax's vaccine has already received some level of approval in dozens of countries around the world, as well as the WHO and the European Commission for primary vaccination for adults 18 and older. "We see ongoing and annual revaccinations into the foreseeable future," Trizzino said. That includes improving booster rates and addressing the market for kids and adolescents where there has been sluggish uptake, he said. Yes, but: But demand for COVID vaccines worldwide has cooled. While about 13 million doses of the Novavax vaccine had been distributed in EU countries as of mid-April, fewer than 200,000 were administered, KHN reported. "They are applying for an emergency authorization" from the FDA, said Manon Cox, a vaccine industry consultant and the former CEO of Protein Sciences, which made a similar vaccine, told KHN. "What's the emergency?" But, but, but: Concerns about mRNA technology have kept plenty of Americans on the sidelines when it comes to the vaccines. It's possible, though not probable, they may embrace the Novavax shot, experts have said. Read the rest.     2. Pregnant women believe vaccine misinformation Data: KFF; Chart: Axios Visuals Most people — including seven in 10 women who are pregnant or trying to get pregnant — believe misinformation or are uncertain about at least one of three false claims they've heard, a new KFF COVID-19 Vaccine Monitor shows.     3. Medicare premiums to get cut — but not yet Medicare beneficiaries will have to wait until next year for a premium cut stemming from lower-than-expected costs covering the questionable Alzheimer's treatment Aduhelm, Axios' Adriel Bettelheim writes. The big picture: CMS recommended passing on savings to people who got slammed with a big hike last year largely due to the price tag for Biogen's drug. Between the lines: The FDA issued an "accelerated approval" for Aduhelm in June 2021, and Biogen priced the drug at $56,000 per year on average before cutting the cost in half. Medicare this year limited coverage of the drug to patients enrolled in a randomized clinical study, signaling that the medication with unproven clinical benefit and serious side effects has to be shown to work to gain full coverage and payment. The combined effects of the price cut and coverage decision would've put the 2022 Part B premium at $160.40 instead of $170.10, officials wrote in a report to HHS Secretary Xavier Becerra. CMS determined a mid-year premium rollback "to not be operationally feasible." What we're watching: HHS hasn't said how much premiums will be lowered for the program's more than 61 million recipients. The 2023 premium will be announced this fall.     A message from PhRMA Out-of-pocket costs create significant barriers to care     New data show that 35% of insured Americans spent more on out-of-pocket costs than they could afford in the past month. The story: Many patients are experiencing an insurance system that isn't working for those who need care. Learn how insurance is leaving patients exposed to deepening inequities.     4. Youth vaping reversed declines in tobacco use Data: Pierce, et al., 2022, Daily E-cigarette Use and the Surge in JUUL Sales: 2017–2019; Chart: Simran Parwani/Axios More than a million teens started vaping from 2017 to 2019, throwing decades of declining tobacco use in reverse, Axios' Arielle Dreher writes about a new study in Pediatrics. Why it matters: The popularity of Juul in particular led a new generation of 14- to 17-year-olds to get hooked, although use dropped off after an outbreak of vaping-related illnesses and deaths. What they're saying: "We saw a huge increase in addiction," study co-author John Pierce told Axios. Background: Fruit and mint-flavored cartridges in small vaping devices proved highly popular among teenagers. The burst in youth vaping led the FDA to ban most flavored cartridges products in a bid to cut off an alternative nicotine source. Some states subsequently sued Juul over its marketing practices for targeting teens.   Threat level: Chronic exposure to e-cigarette smoke in mice can threaten multiple organ systems, but it will take time to determine the effects in people who vape. The bottom line: "The health consequences are going to be considerable; we just don't know what they're going to be yet," Pierce said.     5. 1 good thing: Drink that coffee Illustration: Maura Losch/Axios   Those who drink coffee — sweetened or not — were less likely to die than non-coffee drinkers in the following seven years, according to a cohort study published Monday in the Annals of Internal Medicine. Why it matters: Previous studies have observed coffee is associated with a lower risk of death but didn't distinguish between unsweetened java and coffee consumed with sugar. The jury's still out on artificial sweeteners. The details: Researchers from Southern Medical University in China examined data from about 171,000 U.K. Biobank study participants. During a seven-year follow-up, participants who drank any amount of unsweetened coffee were 16% to 21% less likely to die than participants who did not drink coffee. Participants who drank coffee sweetened with sugar were 29% to 31% less likely to die. Be smart: This observational study doesn't prove cause and effect and doesn't mean one should start drinking coffee for its benefits, said Christina Wee, the editor of the paper from the Annals of Internal Medicine. She wrote a corresponding editorial about the study. It also doesn't offer carte blanche to drink unlimited caramel macchiatos. But: "If you're a regular coffee drinker, there's no need to give it up," Wee said. This author, who drinks her coffee black, is glad to hear it.     6. While you were weekending... Illustration: Aïda Amer/Axios   🍓 The FDA is investigating a Hepatitis A outbreak in the U.S. and Canada linked to strawberries sold at Walmart, Safeway, Trader Joe's and other major grocery stores. (Axios) 🌍 ICYMI: COVID-19 was largely ignored as a clear and present risk to the assembled delegates and hangers-on at the first annual World Economic Forum in Davos held since the pandemic brought the global economy to its knees. (Axios) 👉 There is growing evidence that MDMA — the illegal drug known as ecstasy or molly — could offer "long-term healing" for those suffering from PTSD. (New York Times)     A message from PhRMA Voters want Congress to address health insurance     According to a new poll, 71% of Americans would like to see Congress focus more on reducing the overall costs of health care coverage such as premiums, deductibles and copays. The reason: Many believe current health insurance coverage options are confusing and unaffordable.   Like this email style and format? It's called Smart Brevity®. Over 200 orgs use it — in a tool called Axios HQ — to drive productivity with clearer workplace communications.   Axios thanks our partners for supporting our newsletters. 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