Care Access Claims No Misconduct Found by FDA Regarding Lyme Vaccine Trials

Reuters published an update on Pfizer’s Lyme vaccine trials (10.11.2023), “FDA finds no misconduct at trial sites for Pfizer’s Lyme disease shot, Care Access says.” According to the article, the third party contract research firm, Care Access, has said that the FDA regulator did not find any misconduct at clinical sites managed by Care Access for Pfizer/Valneva’s trial of a Lyme disease vaccine candidate. 

In February 2023, Pfizer and Valneva had announced that they will stop testing the vaccine in roughly half of US patients in the late-stage trial, due to a breach of “clinical trial guidelines” by the third party contract research firm. Pfizer did not disclose the name of the contractor nor the number of patients affected by this announcement at the time, however Care Access has disclosed that the study was discontinued at their firm’s trial sites in over 3,000 participants earlier this year.

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