ARTICLE | Regulation

May 18 Quick Takes: Vaccines panel backs Pfizer RSV vaccine

Plus: Pressure mounts on CMS over Alzheimer’s therapies, financing updates for Coherent, Myeloid, Cabaletta, RedCloud, CytoCares, and more   

May 18, 2023 11:25 PM UTC

There was no doubt among members of FDA’s Vaccines and Related Biological Products Advisory Committee that the data for maternal RSV vaccine Abrysvo from Pfizer Inc. (NYSE:PFE) support efficacy, but several members raised safety concerns including an increased risk of pre-term birth and potential risks associated with co-administration of other vaccines. The panel voted unanimously (14-0) that the data support efficacy of the maternal vaccine, which is designed to protect infants after birth, but voted 10-4 on safety. The panel members urged the regulator and sponsor to systematically collect post-market data to answer lingering safety questions in the broader, more diverse general population, which could impact development of future maternal vaccines.

Political pressure on CMS to grant broad coverage to Alzheimer’s drugs is increasing in anticipation of FDA granting full approval to Leqembi lecanemab from Eisai Co. Ltd. (Tokyo:4523) and Biogen Inc. (NASDAQ:BIIB). Republicans have criticized CMS for restricting coverage of Alzheimer’s mAbs, and Rep. Anna Eshoo (D-Calif.) has expressed frustration with the slow pace of establishing the registries CMS requires for access. Sen. Ron Wyden (D-Ore.), chair of the Finance Committee, released a letter Thursday that supports imposition of a coverage with evidence development (CED) requirement on approved Alzheimer’s therapies, but states that CED should not create barriers to access. “Medicare providers and patients need timely, critical information from CMS about how registry or other CED studies can be put in place for Alzheimer’s disease mAbs and how providers will be able to enroll their patients in all areas of the country without excessive burden. Physicians who administer these medications need a simple, direct way to submit data and provide treatment to qualifying patients.”...