Invivyd Commends FDA Focus on Contemporary Evidence In Evaluating Medical Interventions To Prevent COVID-19

Core Insights - Invivyd, Inc. commends the FDA for addressing uncertainties regarding COVID-19 vaccine booster efficacy and providing a pathway to resolve these issues [1][4] - The FDA has encouraged manufacturers to conduct randomized, placebo-controlled trials to evaluate the efficacy of COVID-19 vaccines, particularly in individuals who have had COVID-19 within the past year [2][4] - Invivyd's CANOPY Phase 3 clinical trial of pemivibart demonstrated an 84% reduction in the risk of symptomatic COVID-19 compared to placebo, highlighting the potential of monoclonal antibodies as a viable alternative to vaccines [2][3][4] FDA's Actions and Recommendations - The FDA has identified gaps in the understanding of COVID-19 vaccine booster efficacy and has called for trials to include healthy adults and those who have had COVID-19 recently [2][4] - The FDA considers a 30% reduction in symptomatic COVID-19 as "meaningful" protection, while Invivyd's pemivibart showed an 84% reduction, suggesting a significantly higher level of efficacy [3][4] Invivyd's Clinical Trials and Products - The CANOPY Phase 3 trial included a randomized cohort of individuals at risk of acquiring SARS-CoV-2, with a follow-up period of six months to assess the durability of the vaccine's efficacy [2][14] - Invivyd plans to advance next-generation monoclonal antibodies to improve scalability and efficacy, with an update on investigational mAb VYD2311 expected soon [4][6][15] Monoclonal Antibodies as a Treatment Option - The FDA has acknowledged the uncertainty surrounding the benefits of repeat COVID-19 vaccine boosters, positioning monoclonal antibody therapies like pemivibart as a critical alternative [4][5] - Invivyd emphasizes the importance of monoclonal antibodies for high-risk populations, particularly children, due to the limitations of vaccination strategies [5][6] Future Developments - Invivyd is set to engage with the FDA on expedited pathways for developing scalable COVID-19 prevention and treatment options, addressing the ongoing health crisis posed by COVID-19 [4][6][17] - The company is focused on delivering high-quality protection against COVID-19, with a commitment to advancing innovative antibody candidates [17]