EMA takes Pfizer and Valneva Lyme disease vaccine into review

The European Medicines Agency (EMA) has validated the marketing authorization application for PF-07307405, the six-valent Lyme disease vaccine candidate from US pharma major Pfizer (NYSE: PFE) and French vaccine specialist Valneva (Nasdaq: VALN), and has begun its assessment. No human Lyme vaccine is approved anywhere at present.

Validation confirms that the dossier is complete and passes no judgment on the data. The European review now proceeds on its own timetable, separate from any US process. The program holds PRIME designation from the EMA and Fast Track status from the Food and Drug Administration (FDA).