Pfizer and Valneva’s Lyme Disease Vaccine Enters EMA Review Phase
Event summary
- The European Medicines Agency (EMA) has validated the Marketing Authorization Application for Pfizer and Valneva’s Lyme disease vaccine candidate PF-07307405.
- The application is based on Phase 3 trial data showing over 70% efficacy in preventing Lyme disease in individuals aged five years and older.
- Pfizer and Valneva entered a collaboration agreement in April 2020 for the co-development and commercialization of the vaccine candidate.
- The vaccine targets six Borrelia OspA serotypes prevalent in North America and Europe.
The big picture
Pfizer and Valneva’s Lyme disease vaccine candidate represents a significant step forward in addressing the most common vector-borne illness in Europe. The validation of the Marketing Authorization Application by the EMA underscores the strategic importance of this collaboration, which aims to provide an important new layer of protection against a debilitating disease with expanding geographic reach.
What we're watching
- Regulatory Approval Timeline
- The pace at which the EMA completes its review will determine the commercial launch timeline for PF-07307405 in Europe.
- Market Penetration Strategy
- How Pfizer and Valneva plan to position the vaccine against Lyme disease, which affects over 100,000 people annually in Europe.
- Competitive Landscape
- Whether other pharmaceutical companies will accelerate their own Lyme disease vaccine development programs in response to this regulatory milestone.
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