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Novavax Announces Participation in Two Booster Studies Using its COVID-19 Vaccine
U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current FDA approved or emergency use
About this update from Novavax, Inc.
[{"type":"text","content":"U.S. NIAID-sponsored trial will evaluate heterologous booster regimens, including NVX-CoV2373, after primary series with current FDA approved or emergency use authorized-vaccines NVX-CoV2373 will be evaluated in a head-to-head boosting trial in the United Arab Emirates to assess boosting options for a large number of the world's population that have previously been vaccinated with inactivated COVID-19 vaccineGAITHERSBURG, Md., March 25, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine, is included in two trials now underway to evaluate its vaccine's safety, immunogenicity, and reactogenicity as a booster amidst the ongoing COVID-19 pandemic. Both studies have initiated participant enrollment and will help to extend knowledge of how a range of vaccines, including Novavax' COVID-19 vaccine, can be used as boosters following primary immunization.\n\"Additional COVID-19 booster studies are important to support vaccine choice for individuals, healthcare providers, and public health authorities,\" said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. \"Our COVID-19 vaccine has already been recommended by multiple national policy bodies for both primary vaccination and booster settings in individuals 18 years of age and older. We look forward to adding to this body of evidence to support the expanded use of our protein-based vaccine.\"\nNovavax is participating in an ongoing Phase 1/2 trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) to assess homologous and heterologous boosting regimens in participants who received a primary series of a COVID-19 vaccine which has received full approval or Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Participants will be given a third dose (> 12 weeks later) of either NVX-CoV2373 or one of the three COVID-19 vaccines that have already received EUA or full authorization from the FDA. The study is enrolling approximately 1,130 healthy individuals aged 18 years or older, about 180 of whom will receive NVX-CoV2373 as a heterologous booster. The trial is being conducted at approximately 10 clinical research sites and its primary object...