Pfizer and Valneva’s investigational Lyme disease vaccine candidate, PF-07307405 (LB6V), demonstrated more than 70% efficacy in preventing Lyme disease among individuals age 5 and older, according to topline phase 3 trial results.
The prespecified analysis showed 74.8% efficacy starting one day after the fourth dose and 73.2% efficacy starting 28 days after the fourth dose, according to a March 23 news release from Pfizer. The drugmaker said that although the study accrued fewer confirmed cases than anticipated and did not meet the statistical threshold for the first prespecified endpoint, the results support clinical benefit and that it plans to move forward with regulatory submissions.
The vaccine candidate was well tolerated, with no safety concerns identified at the time of analysis, according to the release.
The 6-valent OspA-based vaccine is being co-developed under a 2020 collaboration and license agreement between Pfizer and Valneva, which states that Pfizer will manufacture and commercialize the vaccine, pending regulatory approval.
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