Pfizer and Valneva have announced that the Marketing Authorisation Application (MAA) for their Lyme disease vaccine candidate has been validated by the European Medicines Agency (EMA).
The MAA is for PF-07307405, the companies’ 6-valent outer surface protein A (OspA)-based vaccine candidate.
The application is based on encouraging efficacy of more than 70% observed in the phase 3 VALOR clinical trial, which investigated whether the vaccine candidate, PF-07307405, prevented Lyme disease cases in individuals aged five years and older.
The VALOR trial was conducted at sites in areas of high incidence of Lyme disease across the US, Canada and Europe and included 9,437 trial participants aged five years and older. The vaccine was well tolerated in the trial, with no safety concerns identified.
Thomas Lingelbach, CEO and Board member of Valneva, said: “MAA acceptance represents a major milestone, especially considering that more than 200 million people live in Lyme disease risk areas in Europe.”
Lyme disease is a systemic infection caused by bacteria that are transmitted to humans by the bite of infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere. The Centers for Disease Control and Prevention (CDC) has estimated that approximately 476,000 people in the US are diagnosed and treated each year and 132,000 cases are reported annually in Europe from countries with surveillance systems.
Early symptoms of Lyme disease (such as a gradually expanding erythematous rash called erythema migrans or other nonspecific symptoms like fatigue, fever, headache, mild stiff neck, muscle and joint pains) are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious chronic complications affecting the skin, joints (arthritis), the heart (carditis) or the nervous system. The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.
There are currently no approved human vaccines for Lyme disease. PF-07307405 is the current Lyme disease vaccine candidate which has advanced the furthest along the clinical development timeline, with two pivotal phase 3 trials completed.
Annaliesa Anderson, Senior Vice President and Chief Vaccines Officer at Pfizer, said: “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.”