Pfizer and the biotech company Valneva have announced that they will put their late-stage clinical trial of the Lyme disease vaccine VLA15 on hold following a breach of guidelines by a third-party contractor, according to an article published in Reuters. The article did not disclose the violations but suggested that they could affect 2,000 of the 6,000 anticipated trial participants. As tick populations continue to rise, researchers expressed concern about the setback—which may delay the vaccine’s approval by 1 year. However, Pfizer stated that it still plans to recruit participants at other locations not affiliated with the third-party contractor and submit marketing applications in 2025.
July 11, 2023