Axios Vitals: The next booster data problem

Plus: Air ambulance costs soar | Friday, October 01, 2021

Open in app View in browser   Presented By PhRMA   Axios Vitals By Tina Reed ·Oct 01, 2021 🍁 Happy first day of October, Vitals readers. Today's newsletter is 834 words or a 3-minute read. Situational awareness: Merck and Ridgeback Biotherapeutics announced positive interim results for its COVID antiviral drug and said they plan to seek emergency use authorization in the U.S. as soon as possible.     1 big thing: Data holes complicate Moderna and J&J boosters Illustration: Megan Robinson/Axios   Now that some recipients of the Pfizer COVID-19 vaccine can receive a booster, attention has turned to whether, and when, recipients of the Moderna or Johnson & Johnson vaccines will get extra shots, Axios' Caitlin Owens writes. Why it matters: Regulators had issues with the quantity of data available for boosting with Pfizer, and there's even less — at least publicly available — for the other two vaccines. The big picture: The U.S. has relied heavily on other countries' data, particularly Israel's, when it comes to making booster decisions. "If we had the U.S. national data, the whole country, or even just all health care workers, we would have this nailed. But we have such poor data aggregation in this country," said Eric Topol, executive vice president of Scripps Research. Where it stands: Moderna has asked for authorization of a third shot for its recipients, but with a dose half the size of the original two. J&J recently put out a press release outlining results from its clinical trials evaluating a second shot two and six months after the first. But it's unclear whether the full six-month data will be available by the time the FDA reviews J&J boosters, according to a source familiar with discussions. A second source familiar with the situation said the full clinical trial results of a second J&J dose after six months aren't expected until early November. Yes, but: Even if regulators end up having less data to consider — which is still a big if — it may not matter that much to the outcome. "It's almost unimaginable now that they won't approve additional Moderna and J&J doses. That'd add more chaos to whats been a pretty anarchistic situation over the last few months," said Cornell virologist John Moore. Read more.     2. More details on surprise billing ban Insurers are happy with the Biden administration's planned implementation of Congress' ban on surprise medical bills. Hospitals are not. Driving the news: HHS released a new rule yesterday that resolves one of the trickiest issues: how dispute resolution should work between out-of-network providers and insurers. Details: Payers and providers must start with a 30-day "open negotiation" to determine a payment rate, the proposed rule says. If that fails, they can go to arbitration. Arbitrators will come up with a price using what the insurer pays other providers for the same service in the same area as a guide. The rule also requires providers and hospitals to give a "good faith estimate" to uninsured patients. What they're saying: The rule "is a total miscue," Federation of American Hospitals CEO Chip Kahn said in a statement. "It inserts a government standard pricing scheme arbitrarily favoring insurers." The other side: "We are particularly encouraged to see the rules conform to the intent of the No Surprises Act," America's Health Insurance Plans CEO Matt Eyles in a statement.     3. Air ambulance costs soar Illustration: Lazaro Gamio/Axios   The cost of air ambulances skyrocketed between 2017 and 2020, according to a white paper provided first to Axios by FAIR Health. By the numbers: Insurers' average payment for helicopter ambulances rose by 61%, and their payments for airplane ambulances jumped by 76%, to nearly $16,000. Medicare payments did not rise nearly as much — they increased by an average of about 5%, for both helicopters and ambulances. Between the lines: These are the prices insurers pay, but air ambulance rides are often out-of-network, and patients who need one are never in a position to bargain or shop for a better deal.     A message from PhRMA People want choice and access to medicines in Medicare – not barriers     Right now, Medicare Part D includes a provision that protects access to medicines. But some politicians want to take that away. That would mean that you could be stuck with whatever medicines the government says you can have. Ask Congress if your medicine will be at risk in Medicare.     4. Proteins give clearer picture of cancer growth Illustration: Rebecca Zisser/Axios   Unique networks of hundreds of proteins may drive the growth of breast, head and neck cancers, according to three new studies, Axios' Eileen Drage O'Reilly reports. The latest: The journal Science on Thursday posted studies with an analysis that mapped 395 protein systems in 13 cancer types, focusing on data from studies on head and neck squamous cell cancers and breast cancers. The three related papers examined how hundreds of mutations in breast and head and neck cancers affect the activity of proteins that drive the diseases. What's next: Researchers will continue working on the big question: which mutations in different genes affect the interactions of proteins that drive cancer growth, Marcus Kelly, postdoctoral researcher and a co-author of one of the papers, tells Axios. "We are looking at these protein systems at multiple scales. Some of these protein systems are kind of small clumps of proteins that basically always stick together, and others are these signaling pathways that involve a bunch of different proteins, handing information off to each other," he says. Go deeper.     5. Quote du jour Photo: Greg Nash-Pool/Getty Images   "Fifty years ago, some people protested using seat belts. Today, we don't. We know how safe and effective they are. Same thing with vaccines. Same thing with masks." — HHS Secretary Xavier Becerra speaking at a Senate committee hearing about keeping kids safe in the return to school during COVID.     6. Dog of the week Cooper. Photo: John B. Mitchell   Meet Cooper, a golden retriever who was nominated by dad John B. Mitchell, a pharma marketing consultant in Northhampton, Massachusetts. Cooper is shown here after a two-hour morning adventure of running and playing with eight other dogs.     Correction The lead item in the Sept. 24 edition of Vitals misstated PhRMA's position on compulsory licensing in drug manufacturing. The article stated that PhRMA would have previously supported allowing generic drugmakers to manufacture vaccines without the patent owners' approval. It has been corrected to reflect PhRMA's opposition to that practice. We regret the error.     A message from PhRMA People want choice and access to medicines in Medicare – not barriers     Right now, Medicare Part D includes a provision that protects access to medicines. But some politicians want to take that away. That would mean that you could be stuck with whatever medicines the government says you can have. Ask Congress if your medicine will be at risk in Medicare.   Like this email style and format? Learn more about Axios HQ. It'll help you deliver employee communications more effectively.   Axios thanks our partners for supporting our newsletters. If you're interested in advertising, learn more here. Sponsorship has no influence on editorial content. Axios, 3100 Clarendon B‌lvd, Suite 1300, Arlington VA 22201   You received this email because you signed up for newsletters from Axios. Change your preferences or unsubscribe here.   Was this email forwarded to you? 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