Pfizer Says Long-Awaited Lyme Vaccine Was Effective in Study

[Mij]

Pfizer Inc. said its experimental Lyme disease vaccine was 73% effective against the tick-borne illness, though fewer-than-expected cases in a study made it hard to determine how well it works on a large scale.

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While the vaccine reduced cases of Lyme, it did not clearly meet the clinical trial’s efficacy criteria. That doesn’t mean the shot failed to work. Pfizer gave it to people in the US, Canada and Europe who were at high risk of exposure, but fewer than expected got infected, confounding the results.

Pfizer said it’s confident in the vaccine’s potential and plans to submit it to regulatory authorities. The stock dropped 1% in trading before US exchanges opened, paring an earlier decline. Partner Valneva SE plunged as much as 13% in Paris, the most in two months.

In the study, patients received three doses of the vaccine over the course of up to nine months. They then got a fourth dose one year later. In the 28 days following the last dose, the vaccine was 73% effective, Pfizer said. If it’s approved, people will likely need to get annual boosters.

 

[InitialConditions]

Anyone know how they are testing for Lyme?

 

[Mij]

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)

There is no info on Lyme testing that I can find.

Key Exclusion Criteria:

• Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding.
• Any diagnosis of Lyme disease within the past 3 months.
• Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated Lyme disease regardless of when diagnosed.
• Known tick bite within the past 4 weeks.
• Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
• Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease.
• Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.