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Showing posts with the label Vaccine Clinical Trials

Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate Press Release

  August 5, 2021 Pivotal study VLA1553-301 met its primary endpoint Vaccine candidate induced protective CHIKV neutralizing antibody titers in 98.5% of subjects after a single vaccination VLA1553 was well tolerated across all age groups Final trial results expected within the next six months Saint Herblain (France), August 5, 2021  – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive topline results from the Phase 3 pivotal trial of its single-shot chikungunya vaccine candidate, VLA1553. VLA1553 was recently awarded Breakthrough Designation status by the Food and Drug Administration (FDA). The trial, involving 4,115 adults, aged 18 years and above, across 44 sites in the U.S., met its primary endpoint inducing protective CHIKV neutralizing antibody titers in 98.5% of participants 28 days after receiving

J&J adds to COVID-19 vaccine armoury with 66% efficacy in global trial Reuters

  (Reuters) - Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus. In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread. A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses. Those trials, however, were conducted mainly in the United States and before new variants emerged. The top U.S. infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging. “It