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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
WALTHAM, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from historical approaches to the development of vaccines and monoclonal antibodies (mAbs) for COVID-19 prevention, in order to rebuild American’s trust in scientific data, public health recommendations, and preventatives, including mAbs and vaccines, when effective. Americans will need a
About this update from Invivyd, Inc.
[{"type":"image","alt":"Invivyd","displaySize":"","headline":null,"caption":"Invivyd","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":44,"url":"https://media.zenfs.com/en/globenewswire.com/4a4d9d450de79e16fc0a485fff104ca6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/MyR5b2vdhRgALtKrzLKLAQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYyO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/4a4d9d450de79e16fc0a485fff104ca6","width":300,"height":44}},"lazy":false},{"type":"text","content":"WALTHAM, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from historical approaches to the development of vaccines and monoclonal antibodies (mAbs) for COVID-19 prevention, in order to rebuild American’s trust in scientific data, public health recommendations, and preventatives, including mAbs and vaccines, when effective. Americans will need a robust arsenal to manage COVID-19 and other viral infectious disease for decades to come.","length":590,"tagName":"p"},{"type":"text","content":"Over the last few years, Americans have undergone an extraordinary change, as has SARS-CoV-2. In 2020, Americans were immunologically naïve to any exposure to the virus that causes COVID-19 when original vaccine efficacy studies were conducted, but today virtually all Americans have some immunologic memory from either subsequent vaccination or infection from circulating virus.","length":379,"tagName":"p"},{"type":"text","content":"Further, during the first two years of the pandemic, and critically, during the original vaccine field studies, the SARS-CoV-2 virus moved from Wuhan through Delta lineages, which were highly susceptible to human immune pressure, to highly immune evasive Omicron lineages beginning late 2021. Indeed vaccines produce lower antiviral titers following vaccination against Omicron lineages than they did against original Wuhan lineages.","length":433,"tagName":"p"},{"type":"text","content":"Finally, the biological phenomena leading to the rapid waning of vaccine efficacy over months is now better understood than it was in 2020, requiring prospective long-term evaluation in clinical trials rather than the short-term studies that provide published vaccine efficacy estimates on produc...