The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Pfizer and Valneva’s investigational Lyme disease vaccine, allowing the regulatory review process to begin.
The vaccine candidate, PF-07307405, is a six-valent outer surface protein A (OspA)-based vaccine designed to help protect against Lyme disease. The companies are developing the vaccine for people aged five years and older.
The application is supported by results from the Phase 3 VALOR clinical trial, which showed more than 70% efficacy. The study evaluated whether PF-07307405 could prevent Lyme disease in people who may be exposed to ticks during outdoor activities.
The vaccine candidate was also well tolerated in the trial, with no safety concerns identified by the companies.
Lyme disease is the most common vector-borne disease in Europe, according to Pfizer and Valneva. More than 100,000 cases are reported in Europe each year, while more than 200 million people live in areas where they may be at risk of Lyme disease.
The disease is caused by bacteria transmitted through the bites of infected ticks. If it is not treated, Lyme disease can lead to longer-term health problems affecting the skin, joints, nervous system and heart.
Pfizer’s Senior Vice President and Chief Vaccines Officer Annaliesa Anderson said the EMA application validation marks an important step toward potentially bringing a Lyme disease vaccine to Europe.
“We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease,” Anderson said.
Valneva CEO Thomas Lingelbach also described the EMA validation as a major milestone for the program. He highlighted the large number of people living in Lyme disease risk areas across Europe.
PF-07307405 is being developed through a collaboration between Pfizer and Valneva. The vaccine has been studied for efficacy, safety, tolerability and its ability to produce an immune response. The companies have also evaluated the consistency of different manufacturing lots.
The two companies entered into a collaboration and license agreement in April 2020 to jointly develop the vaccine. Under the agreement, Pfizer has exclusive rights to manufacture and commercialize PF-07307405 if it receives the required regulatory approvals.
The EMA validation does not mean the vaccine has been approved. It confirms that the application has met the requirements to begin the formal review process. The EMA will now assess the available clinical and manufacturing data before making a recommendation on whether the vaccine should be authorized in the European Union.
If approved, PF-07307405 could become an important new prevention option for Lyme disease, particularly for people living in or traveling to areas where infected ticks are common.