EMA Validates Lyme Disease Vaccine Candidate Application Pfizer and Valneva’s Lyme disease vaccine candidate has reached a major regulatory milestone. The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA). The application covers PF-07307405, a 6-valent OspA-based Lyme disease vaccine candidate. Pfizer Inc. and Valneva SE announced the development in a joint statement. The EMA will now begin its formal assessment of the application.
The submission follows encouraging results from the Phase 3 VALOR clinical trial. The study evaluated PF-07307405 for its ability to prevent Lyme disease cases. It included individuals aged five years and older. The trial reported efficacy above 70 percent.Furthermore, the vaccine candidate showed a favorable safety profile.Researchers found no safety concerns during the trial.The vaccine was also well tolerated among participants.
The Phase 3 VALOR trial is formally known as “Vaccine Against Lyme for Outdoor Recreationists.” The clinical study is registered under NCT05477524. It assessed the vaccine candidate across several important clinical development measures.These measures included efficacy, safety, tolerability, and immunogenicity. The trial also evaluated manufacturing lot consistency.
“I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart. We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.”
Pfizer and Valneva Advance Vaccine Development
The EMA validation marks another important step for the Lyme disease vaccine candidate. It also moves the potential vaccine closer to regulatory review in Europe. Lyme disease continues to create a significant public health burden across affected regions.Accordingly, vaccine development remains an important area of research.
“We would like to thank and congratulate our partner Pfizer for the significant progress achieved towards delivering a potential vaccine solution in the fight against Lyme disease. MAA acceptance represents a major milestone, especially considering that more than 200 million people live in Lyme disease risk areas in Europe,” said Thomas Lingelbach, CEO and Board member of Valneva.
Pfizer and Valneva developed the investigational vaccine through a strategic collaboration. The companies designed the vaccine as a 6-valent OspA-based candidate. They have studied its efficacy, safety, tolerability, and immunogenicity.They have also assessed manufacturing lot consistency during clinical development.
The companies entered a collaboration and license agreement in April 2020. Under the agreement, Pfizer and Valneva agreed to co-develop PF-07307405. Pfizer will exclusively manufacture and commercialize the vaccine if regulatory approval succeeds.
PF-07307405 Targets Lyme Disease Bacteria
There are currently no approved human vaccines for Lyme disease.PF-07307405 has advanced significantly through the clinical development process. The candidate has completed two pivotal Phase 3 trials. As a result, it remains one of the most advanced Lyme disease vaccine programs. The investigational vaccine uses a multivalent protein subunit approach.It targets outer surface protein A, also known as OspA. OspA exists on Borrelia burgdorferi, the bacteria responsible for Lyme disease.
The vaccine works by stimulating the body to produce specific antibodies. These antibodies target six different Borrelia OspA serotypes. When a tick feeds on a vaccinated person, it takes in these antibodies. The antibodies then interact with OspA on Borrelia inside the tick. This interaction inhibits the bacterium from leaving the tick. Consequently, the mechanism can prevent transmission to the human host.
The vaccine candidate targets six prevalent OspA serotypes. These serotypes occur within the Borrelia burgdorferi sensu lato species. The coverage includes serotypes found across North America and Europe. The latest regulatory development therefore represents an important step. Pfizer and Valneva will now proceed through the EMA review process. The assessment will determine the next stage for the vaccine candidate in Europe.
The development could also expand preventive options against Lyme disease. However, the candidate remains investigational while regulatory authorities conduct their assessment. The companies will continue working with regulators throughout the review cycle.
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News Source: Businesswire.com
