Pfizer and Valneva Seek Food and Drug Administration Approval for Lyme Vaccine Despite Trial Issues

Pfizer and Valneva plan to seek regulatory approval for their Lyme disease vaccine candidate after clinical trials demonstrated over 70% efficacy in preventing infections.Although the VALOR study failed to meet its primary statistical confidence threshold due to low infection rates among participants, adjusted data showed the four-dose regimen significantly reduced disease cases.The vaccine requires three initial doses followed by a booster shot to induce antibodies that prevent the transfer of bacteria from ticks to humans.If authorized by the Food and Drug Administration, the treatment would become the first human vaccine available for the tick-borne illness since the late 1990s.
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