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Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency
The application is backed by Phase 3 data showing more than 70% efficacy and no safety concerns, the companies said.
- On Friday, the European Medicines Agency validated the Marketing Authorization Application for PF-07307405, a Lyme disease vaccine candidate developed by Pfizer and Valneva under a collaboration agreement.
- Lyme disease is the most common vector-borne illness in the Northern Hemisphere, with approximately 476,000 cases diagnosed annually in the U.S. and 132,000 in Europe; currently, no approved human vaccines exist for the condition.
- Data from the Phase 3 VALOR clinical trial demonstrated encouraging efficacy of more than 70% in participants aged five years and older, targeting six Borrelia OspA serotypes to prevent tick-borne transmission.
- Shares in Valneva surged nearly 16 percent on the news, as CEO Thomas Lingelbach called the EMA's acceptance a "major milestone" given that more than 200 million people live in Lyme disease risk areas in Europe.
- Regulatory assessment will determine if the vaccine's benefits outweigh known risks, as Pfizer Senior Vice President and Chief Vaccines Officer Annaliesa Anderson stated vaccination could provide an "important new layer of protection" against the disease.
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European Union (EU) officials have agreed to evaluate an experimental vaccine against Lyme disease, the world's most common tick-borne disease, the vaccine's developers said on Friday.
·Vilnius, Lithuania
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EU to study potential vaccine for Lyme disease: companies
Pfizer and the French-Swiss firm Valneva say trials have shown a 70 percent efficacy rate in people aged five and above for a disease that currently has no approved vaccine. Despite a disappointing trial result earlier this year, the two firms said the European Medicines Agency had accepted its application for approval of its treatment, formally called PF-07307405. While rarely fatal, Lyme disease can cause rashes and flu-like symptoms among peo…
·Issy-les-Moulineaux, France
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Total News Sources19
Leaning Left1Leaning Right3Center6Last UpdatedBias Distribution60% Center
Bias Distribution
- 60% of the sources are Center
60% Center
C 60%
R 30%
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