Pfizer and Valneva will begin a phase 3 research on a Lyme disease vaccine.

According to Annaliesa Anderson, senior vice president and head of vaccine research and development at Pfizer, "offering a new alternative for patients to help protect themselves against the disease is more vital than ever due to rising global Lyme disease incidence.

We are excited to work with the research sites across the U.S. and Europe on this significant trial. We are hopeful that the data from the phase 3 study will further corroborate the favorable evidence for VLA15 thus far.

Chief Medical Officer of Valneva Juan Carlos Jaramillo stated, "We are delighted to attain this significant milestone in the development of VLA15. Lyme disease, which still has a high unmet medical need and affects many people in the northern hemisphere, is still rising. We eagerly anticipate conducting more research on the VLA15 candidate in phase 3, which will bring us one step nearer to perhaps making this vaccine available to both adults and kids who would benefit from it.

Study Details

Approximately 6,000 people five years of age and older are expected to join in the phase 3 VALOR research, which is randomized, placebo-controlled, and open-label. Up to 50 locations, including those in Finland, Germany, the Netherlands, Poland, Sweden, and the United States, are participating in the project. Following the main immunization series of three doses of VLA15 180 g or saline placebo, participants will get one dose of VLA15 or saline placebo as a booster (1:1 ratio).

Data from the phase 2 trials, according to the firms, continue to show high immunogenicity in both adults and children, with acceptable safety and tolerability profiles in both study groups. In 2025, Pfizer could submit a marketing authorization application (MAA) to the European Medicines Agency (EMA) and a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA), pending the successful conclusion of the phase 3 trial.

About VlA15

The sole option for a Lyme disease vaccine that is presently in clinical research is VLA15.

The outer surface protein A (OspA) of Borrelia burgdorferi, the bacterium that causes Lyme disease, is the target of the investigational multivalent protein subunit vaccine, which employs a proven mechanism of action for a Lyme disease vaccine.

When present in a tick, the bacteria produce the surface protein OspA. The bacteria can't exit the tick and infect people if OspA is blocked. The six most frequent OspA serotypes expressed by the B. burgdorferi sensu lato species found in North America and Europe are covered by the vaccine. In pre-clinical and clinical investigations thus far, VLA15 has shown a potent immune response and an acceptable safety profile.

About Lyme disease

Although the exact prevalence of Lyme disease is unknown, it is expected to infect around 476,000 Americans and 130,000 Europeans each year. Early signs of Lyme disease, including an erythematous rash that progressively spreads and is known as erythema migrans, as well as less-specific symptoms including tiredness, fever, headache, moderate stiff neck, arthralgia, or myalgia, are frequently disregarded or misdiagnosed.

 

If the condition is not addressed, it can spread and result in more severe problems that can damage the joints (arthritis), the heart (carditis), or the brain system. As the illness's geographic reach expands, there is a growing medical demand for the Lyme disease vaccine.

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Comments
rico - Aug 10, 2022, 5:18 PM - Add Reply

Good Article

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rejk - Aug 10, 2022, 5:55 PM - Add Reply

Nice

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qwer - Aug 10, 2022, 6:03 PM - Add Reply

goood

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nabeel - Aug 12, 2022, 6:22 PM - Add Reply

Great Article :)

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