Moderna earnings miss | RSV vaccines | Medicare rejects Alzheimer’s request

VIEW IN BROWSER | SUBSCRIBE Fri, Feb 24, 2023 EDITOR'S NOTE Think a friend or colleague should be getting this newsletter? Share this link with them to sign up.   Moderna missed Wall Street's earnings expectations as the company struggles with idle manufacturing capacity amid lower demand for its Covid vaccine.    The Boston biotech company has $5 billion in vaccine deliveries lined up for 2023, which pales in comparison to the $18 billion it sold in 2022. Moderna does expect additional contracts in the U.S., Europe and Japan, but said demand is dropping as vaccination moves to an annual schedule rather than repeated boosting.    The Covid vaccine remains Moderna's only commercial product, but the company anticipates that its RSV shot could receive approval in late 2023 or early 2024. The immune response data from its flu shot has been mixed, but efficacy data that could lead to an FDA filing are expected later this year.    Pfizer and GSK, meanwhile, could get the nod from the FDA's independent advisors next week for their RSV vaccines for older adults. The vaccines both had strong results in preventing lower respiratory tract disease in clinical trials, but there are concerns that there might be a risk of Guillain-Barre syndrome.    The FDA, in briefing documents ahead of the meetings, said Guillain-Barre is a potential risk with Pfizer's vaccine after two patients were diagnosed in its phase three trial. A single Guillain-Barre case was reported in GSK's trials as well, though the company said there was insufficient information to confirm a diagnosis. Both companies plan post-marketing safety studies to monitor the potential safety issue.    Medicare, meanwhile, has rejected a request from the Alzheimer's Association for unrestricted coverage of Eisai's treatment Leqembi.    And on the abortion front, Democratic attorneys general sued the FDA this week to force the agency to drop all remaining restrictions on mifepristone. It's just one in a number of legal battles over the abortion pill across the U.S. The issue could end up before the Supreme Court. Feel free to send any tips, suggestions, story ideas and data to me at spencer.kimball@nbcuni.com. Spencer Kimball | Health Reporter @spencekimball Spencer Kimball | Health Reporter @spencekimball   Moderna misses on earnings as costs rise from surplus production capacity, lower Covid shot demand Moderna on Thursday missed earnings expectations for the fourth quarter, as costs rose from surplus production capacity and lower demand for its Covid-19 vaccine, the company's only product on the market.   The U.S. government plans to stop buying shots for the public as soon as this summer, shifting procurement and distribution to the private market. Moderna estimates U.S. market volume in fall 2023 will be 100 million doses, said Arpa Garay, the company's chief commercial officer.   Garay wouldn't provide projections on Moderna's share of the fall 2023 U.S. market. She said the company is in discussions with customers for fall contracts. - Spencer Kimball FDA says Guillain-Barre syndrome is possible risk of Pfizer's RSV vaccine for older adults The Food and Drug Administration sees a possible risk of Guillain-Barre syndrome with Pfizer's RSV vaccine for older adults and has asked the company to conduct a safety study if the shot is approved this spring, according to agency briefing documents published Friday.   Two people in their 60s who received Pfizer's shot were diagnosed with Guillain-Barre syndrome, out of about 20,000 vaccine recipients in the phase three trial, according to the FDA document. There were no cases in the trial's placebo group, the people who didn't receive the shot.   Pfizer, in its briefing document, said the cases have other possible explanations. But it said it will conduct a safety study to further assess Guillain-Barre syndrome after a potential approval. - Spencer Kimball Moderna & Merck get breakthrough therapy nod for cancer vaccine but Dems urge Keytruda scrutiny Moderna's stock rose after the FDA granted its personalized cancer vaccine, partnered with Merck, breakthrough therapy designation, which can help speed a drug to market.   The medicine, in a December trial readout, reduced the risk of melanoma recurrence or death by 44% when given with Keytruda, compared with Merck's drug alone. It's seen as an important program for Merck as well, which risks competition to Keytruda when it starts losing patent protection in 2028.   And another of its projects to combat that potential loss of revenue – a reformulation of Keytruda to be administered through subcutaneous injection – got increased scrutiny this week from Democrats led by Elizabeth Warren and Bernie Sanders, who asked the patent office to look closely at Merck's practices around the drug.   With Sanders now helming the Senate health committee, pressure is expected to continue to ratchet up on the industry from Washington. - Meg Tirrell Amazon closes One Medical deal Like a lot of tech companies Amazon has stumbled in health-care services, but closing the One Medical deal this week could be the watershed moment where the retailer turns the corner on consumer health.   CEO Andy Jassy touted the deal on the front page of Amazon's storefront. But the primary-care provider is still not profitable. It lost $400 million last year on $1 billion in revenue.   As Amazon has cut jobs and costs in other divisions, the question is how invested the retail giant is in building One Medical's physical health-care footprint and how patient Jassy will be about getting the overall health-care unit to profitability. - Bertha Coombs Medicare rejects Alzheimer's Association request for unrestricted coverage of treatments like Leqembi Medicare will not provide broader coverage of the Alzheimer's drug Leqembi until it receives more evidence that the treatment is reasonable and necessary, according to the federal agency that runs the program for seniors. The Centers for Medicare and Medicaid Services rejected a request from the Alzheimer's Association for unrestricted coverage of antibody treatments approved by the Food and Drug Administration that target brain plaque associated with the devastating disease.   "After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration," CMS said in a statement on Wednesday. - Spencer Kimball Democratic AGs sue FDA to drop all remaining restrictions on abortion pill A coalition of a dozen Democratic attorneys general sued the Food and Drug Administration on Friday to force the agency to drop all remaining restrictions on the abortion pill, the latest case in an escalating series of legal battles over access to the medication.   The lawsuit filed Friday puts the FDA in the middle of the nation's deep divisions over access to abortion in the wake of the Supreme Court ruling that overturned Roe v. Wade last summer.   A coalition of physicians who oppose abortion have sued the FDA in federal court in Texas to overturn the agency's approval of mifepristone, which dates back more than 20 years, and yank the medication from the U.S. market.   - Spencer Kimball JOIN US REGISTER CONTRIBUTORS Bertha Coombs @berthacoombs Meg Tirrell @megtirrell Bertha Coombs @berthacoombs Meg Tirrell @megtirrell Unsubscribe Manage Newsletters Terms of Service Join the CNBC Panel   Digital Products Feedback Privacy Policy CNBC Events   © 2022 CNBC LLC. All rights reserved. A property of NBCUniversal. 900 Sylvan Avenue, Englewood Cliffs, NJ 07632 Data is a real-time snapshot *Data is delayed at least 15 minutes. Global Business and Financial News, Stock Quotes and Market Data and Analysis. Data also provided by THOMSON REUTERS