Invivyd Files Citizen Petition Urging FDA to Focus on Monoclonal Antibodies For Endemic-Virus-Era COVID-19 Prevention, and to Re-Assess COVID-19 Vaccine Efficacy

Core Viewpoint - Invivyd, Inc. has submitted a Citizen Petition to the FDA advocating for a shift in the development approach for COVID-19 vaccines and monoclonal antibodies to restore public trust and enhance the effectiveness of preventive measures against COVID-19 and other viral diseases [1][6]. Group 1: Changes in Immunity and Virus Evolution - The immunological landscape in the U.S. has changed significantly since 2020, with most Americans now having some level of immunologic memory due to vaccinations or infections [2]. - The SARS-CoV-2 virus has evolved from the original Wuhan strain to more immune-evasive Omicron variants, leading to reduced vaccine efficacy against these newer strains [3]. Group 2: Vaccine Efficacy and Clinical Trials - There is a better understanding of the rapid waning of vaccine efficacy, necessitating long-term clinical evaluations rather than short-term studies [4]. - Invivyd's petition calls for new clinical trials to assess COVID-19 vaccines in a modern U.S. population, including seropositive individuals, and against contemporary Omicron variants, with efficacy measured over six months or longer [6]. Group 3: Monoclonal Antibodies and Regulatory Recommendations - Invivyd emphasizes the importance of developing non-vaccine solutions, such as monoclonal antibodies, to provide high-quality alternatives for the American population [6]. - The petition recommends that the FDA consider serum virus neutralizing antibody (sVNA) titers as a basis for Biologics License Application (BLA) approval, which would benefit patients and healthcare providers [7]. Group 4: Company Overview - Invivyd, Inc. is focused on delivering protection against serious viral infectious diseases, starting with SARS-CoV-2, and has received emergency use authorization for a monoclonal antibody from the FDA [8].