Only three other years during the past three decades did the U.S. FDA approve more new molecular entities (NMEs) than the 50 cleared in 2021, a year that was plagued with numerous delayed decisions. There were 53 NME approvals in 1996 and 53 again in 2020. The record is held by 2018, which had 59 approvals.
During the most infectious COVID-19 month since the pandemic began, January recorded an increase of 82.3 million confirmed cases worldwide, an amount that is fourfold the average monthly increase over the past year. It comes at a time when the highly transmissible omicron variant continues to circulate, bolstered by a new subvariant, BA.2, which is outcompeting its predecessor. Meanwhile, regulatory agencies are authorizing antivirals, swapping monoclonal antibodies based on their efficacy against omicron, and approving new vaccine options, including Novavax Inc.’s protein-based vaccine Nuvaxovid (NVX-CoV2373).