FDA RESTRICTS 2 MONOCLONAL ANTIBODIES AS OMICRON DOMINATES — FDA limited use Monday of two monoclonal antibody treatments believed to be ineffective against the Omicron variant, Lauren reports. The cocktails by Eli Lilly and by Regeneron are not permitted for use in any U.S. jurisdictions because the highly contagious strain now accounts for nearly all domestic infections, regulators said. They can be prescribed only when a patient is likely to have contracted a variant that’s responsive to the treatment. FDA’s move comes as the number of authorized Covid treatments has grown, but some are in short supply. Omicron’s dominance has strained the availability of sotrovimab, GlaxoSmithKline and Vir’s monoclonal antibody that’s shown effectiveness against the variant, and the two antiviral pill options are in short supply and have their own limitations, Lauren writes. Not happy: Florida health officials are livid about FDA’s decision. Republican Gov. Ron DeSantis has pushed for the administration to keep shipping all three antibody cocktails while arguing that some people are still getting infected with the Delta strain. Kenneth A. Scheppke, Florida's deputy secretary for health, accused federal health officials of canceling a phone meeting Monday to discuss the state’s request for 30,000-plus doses of sotrovimab and Regen-COV, Regeneron’s treatment, according to an email shared by the agency. PFIZER: 3 VACCINE DOSES FIGHT OFF OMICRON — A pair of manufacturer-backed lab studies suggests a third dose of the current Pfizer-BioNTech vaccine formulation provokes enough antibodies to fight off the Omicron variant, the companies announced Monday. People who received two doses were shown in tests to have limited antibody levels against the strain, though the companies said they believe the primary series still protects against severe illness thanks to the body’s memory immune cells. PFIZER, BIONTECH LAUNCH OMICRON VACCINE TRIALS — Participants in Pfizer and BioNTech’s Omicron-based Covid-19 vaccine have received their first doses, the companies announced today. The study will compare Pfizer’s current Covid-19 vaccine to one based on the widely circulating variant as a booster or fourth shot in adults who have received two or three doses and a primary vaccine series and booster in those who haven’t been vaccinated yet. “While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research and development, said in a statement. Pfizer and BioNTech have plans to produce 4 billion vaccine doses this year, regardless of whether regulators and public health officials deem an Omicron-specific shot necessary. CMS EXPLORING HAVING MEDICARE COVER HOME TESTS — Biden officials are working to figure out how Medicare will cover rapid covid tests for the program’s roughly 64 million beneficiaries, a senior official at the Centers for Medicare and Medicaid Services told POLITICO’s Rachael Levy. “Medicare has not covered over-the-counter tests before, so this is a new area that we are very quickly developing operations,” the senior administration official said Friday. The official declined to specify the agency’s approach or provide a timeline for rollout. But, the official said, “we are thinking through all different options… we want to make sure that we are turning over every stone to try to improve access as best we can.” FDA AUTHORIZES NEW AT-HOME TEST — FDA announced Monday it granted emergency use authorization to a new over-the-counter serial test. The test, made by Maxim Biomedical, can be used as a single test by people with Covid-19 symptoms. REGULATORS BACK REMDESIVIR USE IN NON-HOSPITALIZED PATIENTS — FDA late Friday expanded the permitted use of remdesivir, an intravenous antiviral drug, to include nonhospitalized Covid patients ages 12 and up who are at risk of progressing to severe illness. The treatment was previously limited to hospitalized patients. Regulators also revised the drug’s emergency use authorization to permit treatment of at-risk pediatric Covid patients weighing 3.5 kilograms to less than 40 kilograms, which opens remdesivir use up to younger children. N95 MASK GIVEAWAY ROLLING OUT — A nationwide distribution of N95 masks kicked off at a Hy-Vee in West Des Moines, Iowa, on Friday, according to a Biden administration official. The first set of federally qualified health centers are scheduled to receive the more protective masks this week and next. “Last week masks began shipping and arriving at pharmacies and grocers around country,” the official said. “We expect that throughout the week the number of stores and N95s arriving to scale up significantly.” | 
