Global Finance News
14 Aug 2026, 15:54
Pfizer and Valneva Lyme Disease Vaccine Application Accepted for EMA Review
Pfizer (NYSE: PFE) and Valneva (NASDAQ: VALN) announced Friday that the European Medicines Agency has validated the Marketing Authorization Application for their experimental Lyme disease vaccine, marking a significant regulatory milestone for the program.
The EMA validation means the agency will now begin formally assessing PF-07307405, a six-valent vaccine designed to prevent Lyme disease in people aged five years and older. The application is supported by results from the Phase 3 VALOR trial.
## Phase 3 Trial Shows More Than 70% Efficacy
In the VALOR trial, the vaccine demonstrated efficacy of more than 70% in preventing Lyme disease and was generally well tolerated, with no safety concerns identified. The randomized study included 9,437 participants aged five and older across the U.S., Canada and Europe.
PF-07307405 targets six variants of outer surface protein A, or OspA, found on the Borrelia bacteria responsible for Lyme disease. The approach is designed to generate antibodies that prevent the bacteria from being transmitted from an infected tick to a vaccinated person.
Potential First Lyme Disease Vaccine Currently Available to Humans
The regulatory milestone could be commercially significant because there are currently no approved human vaccines against Lyme disease. Pfizer and Valneva's candidate is the most advanced Lyme disease vaccine currently in clinical development, with two pivotal Phase 3 studies completed. ([Pfizer][1])
The potential market is substantial. Pfizer said more than 200 million people live in Lyme disease risk areas in Europe, while approximately 132,000 cases are reported annually across European countries with surveillance systems.
Pfizer and Valneva have jointly developed the vaccine under a collaboration established in 2020. If regulatory approval is ultimately secured, Pfizer will be responsible for manufacturing and commercializing the product.
EMA validation does not constitute approval, but it confirms that the application is sufficiently complete to enter the formal regulatory review process. The next major catalyst for the program will therefore be the outcome of the EMA assessment.
Pfizer (NYSE: PFE) and Valneva (NASDAQ: VALN) announced Friday that the European Medicines Agency has validated the Marketing Authorization Application for their experimental Lyme disease vaccine, marking a significant regulatory milestone for the program.
The EMA validation means the agency will now begin formally assessing PF-07307405, a six-valent vaccine designed to prevent Lyme disease in people aged five years and older. The application is supported by results from the Phase 3 VALOR trial.
## Phase 3 Trial Shows More Than 70% Efficacy
In the VALOR trial, the vaccine demonstrated efficacy of more than 70% in preventing Lyme disease and was generally well tolerated, with no safety concerns identified. The randomized study included 9,437 participants aged five and older across the U.S., Canada and Europe.
PF-07307405 targets six variants of outer surface protein A, or OspA, found on the Borrelia bacteria responsible for Lyme disease. The approach is designed to generate antibodies that prevent the bacteria from being transmitted from an infected tick to a vaccinated person.
Potential First Lyme Disease Vaccine Currently Available to Humans
The regulatory milestone could be commercially significant because there are currently no approved human vaccines against Lyme disease. Pfizer and Valneva's candidate is the most advanced Lyme disease vaccine currently in clinical development, with two pivotal Phase 3 studies completed. ([Pfizer][1])
The potential market is substantial. Pfizer said more than 200 million people live in Lyme disease risk areas in Europe, while approximately 132,000 cases are reported annually across European countries with surveillance systems.
Pfizer and Valneva have jointly developed the vaccine under a collaboration established in 2020. If regulatory approval is ultimately secured, Pfizer will be responsible for manufacturing and commercializing the product.
EMA validation does not constitute approval, but it confirms that the application is sufficiently complete to enter the formal regulatory review process. The next major catalyst for the program will therefore be the outcome of the EMA assessment.
