Positive data for Lyme disease booster vaccine

Lyme disease is the most common vector-borne illness in the northern hemisphere, infecting nearly half a million Americans and at least 200,000 Europeans every year.

Caused by the bacteria Borrelia burgdorferi and transmitted to humans by infected ticks, the prevalence of the disease has increased sharply in recent decades, potentially due to changing climatic conditions.

While standard treatment with antibiotics is effective, the symptoms of the infection – a characteristic rash, fatigue, fever, headache and a mild stiff neck – can often be overlooked or misinterpreted. Also, if left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), heart (carditis) or nervous system.

This is why a new vaccine being developed by Valneva and Pfizer is being welcomed, especially as an option for people at high risk of infection.

However, after releasing positive data from its phase 2, VLA15-202 trial last year, an 18-month follow-up showed a decline in antibody titres, which raised the question of a booster shot to boost immunity.

Extending the trial with another shot of the vaccine at 18 months, Valneva and Pfizer have now announced that the booster dose “elicited a strong anamnestic response”, yielding a 2.9-4.2-fold increase in antibody titres compared with those observed after primary immunisation.

“The prevalence and geographic reach of Lyme disease is growing, underscoring the major medical need for vaccination against the disease,” said Kathrin Jansen, head of vaccine R&D at Pfizer. “We look forward to continue our development efforts in our quest to potentially protect people from Lyme disease in the future.”

Valnena and Pfizer announced their collaboration on VLA15 in Lyme disease in August 2020 in a deal worth more than $300, including a $130m upfront payment to Valneva. The company will also receive $35m in development milestones and $143m in early commercialisation milestones.

Under the agreement, Valneva will fund 30% of the development costs and, in return, Pfizer will pay tiered royalties starting at 19%. Pfizer will lead late-stage development and have sole control over commercialisation.

Based in France, specialty vaccine company Valneva focuses on vaccines for infectious disease, with two approved vaccines, Ixiaro/Jespect for the prevention of Japanese encephalitis and Dukoral for the prevention of cholera.