Invivyd ‘commends’ FDA focus on uncertainty around COVID-19 vaccine boosters

nvivyd commends new U.S. Food and Drug Administration leadership on taking important steps to acknowledge and resolve the significant uncertainty surrounding the contemporary COVID-19 vaccine booster efficacy landscape. In a New England Journal of Medicine publication on May 20, 2025, titled “An Evidence-Based Approach to Covid-19 Vaccination,” and in a follow-on live webinar on May 20, 2025, FDA leadership correctly identified gaps in the modern understanding of COVID-19 vaccine booster efficacy and provided a mechanism to resolve those gaps and move forward. Consistent with the requests set forth in the recently filed Invivyd (IVVD) Citizen Petition, the FDA has now “encouraged (COVID-19 vaccine) manufacturers to conduct randomized, placebo-controlled trials in the population of healthy adults,” using the FDA’s “preferred primary end point” of PCR-confirmed symptomatic COVID-19. Importantly, the FDA has affirmed that these clinical trials should include Americans who have had COVID-19 within the past year, a requirement necessary to evaluate efficacy benefits in “the average American,” and which criterion reflects the widespread, damaging, and ongoing impact of COVID-19 in America. Further, these clinical trials should extend for the time period required to adequately characterize potential efficacy waning, specifically “follow-up should extend for a minimum of six months to ensure that early booster gains persist.” These fundamental evidentiary questions, which remain unanswered for today’s COVID-19 vaccine boosters, align well with the design and conduct of Invivyd’s CANOPY Phase 3 clinical trial of pemivibart, which assessed the safety, immunogenicity, and exploratory clinical efficacy of the monoclonal antibody pemivibart to meet the same goals under relevant, modern conditions: CANOPY Phase 3 clinical trial included a placebo-controlled, randomized cohort of average Americans who are “at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings”; CANOPY’s major exploratory clinical efficacy endpoint measured the relative risk reduction of acquiring PCR-confirmed symptomatic COVID-19 in this population, and against modern immune-evasive COVID-19 virus variants, between pemivibart and placebo; and CANOPY Phase 3 clinical trial included a formal evaluation period of six months, during which pemivibart conferred an 84% reduction in the risk of subjects becoming sick from COVID-19 compared to placebo, and then a further six-month follow up period, in which residual low drug concentrations delivered further high protection.