Invivyd announces business readiness update, granted EUA for PEMGARDA

Invivyd announced a business readiness update in response to a recent increase in COVID-19 cases nationwide. According to the Centers for Disease Control and Prevention, as of early September, the rate of death due to COVID-19 has continued to increase throughout 2024. While the CDC recommends COVID-19 vaccination for a broad population, the U.S. Food and Drug Administration has recognized there are vulnerable individuals at high-risk of infection and that require a preventative therapeutic alternative where vaccines may not provide adequate protection. Invivyd’s PEMGARDA, an investigational monoclonal antibody that has been granted Emergency Use Authorization, EUA, by the FDA for pre-exposure prophylaxis, PrEP, of COVID-19 in certain adults and adolescents