Health · Pharma & Biotech · 4 hrs ago
EMA reviews Lyme disease vaccine that targets bacteria inside ticks
Pfizer and Valneva’s Lyme vaccine is under review by the European Medicines Agency, which will assess whether it can be approved for use.
Lyme disease is an infection spread by ticks, and it is a major vector-borne infection in Europe.
The vaccine uses antibodies to stop bacteria inside feeding ticks before they can pass into a person’s bloodstream.
In a phase 3 trial involving more than 9,400 people aged five and older, the vaccine reduced confirmed cases by more than 70%, reaching 74.8% with booster doses.
The trial took place in Lyme-risk areas of the United States, Canada and Europe, but Spain was not among the participating countries.
The vaccine requires several injections, and the trial results showed it was effective and safe, according to an expert quoted in the source.
The EMA review takes an average of 12 months before its medicines committee gives a final opinion.
The European Medicines Agency is reviewing VLA15, a Lyme disease vaccine developed by Pfizer and Valneva.
The vaccine is designed to make antibodies enter a tick’s gut and neutralise Borrelia bacteria before they can be transmitted.
In the phase 3 VALOR trial, the vaccine reduced confirmed Lyme disease cases by more than 70%, reaching 74.8% with booster doses.
The trial involved more than 9,400 people aged five and older in endemic areas of the United States, Canada and Europe.
The EMA validated the application to begin scientific evaluation on 13 August, and its medicines committee has yet to issue a final opinion.
- Who
- Pfizer and Valneva developed the vaccine. The EMA is reviewing it.
- What
- The agency is evaluating VLA15, a vaccine intended to prevent Lyme disease by neutralising bacteria inside feeding ticks.
- When
- The EMA validated the application on 13 August. The review is ongoing.
- Where
- The EMA is assessing the application in Europe; the trial included sites in the United States, Canada and Europe.
- Why
- The vaccine aims to reduce Lyme disease infections by stopping Borrelia bacteria from being transmitted by ticks.
This story does not have two clearly opposing sides.
Spain recorded 1,865 hospitalisations for Lyme disease, according to a report published in 2022.
The EMA validated the application for VLA15 to begin scientific evaluation.
VALOR trial results were presented at the IDWeek conference in Washington.
Marco Cavaleri discussed the vaccine at a seminar at the EMA’s headquarters in Amsterdam.
- Vaccine
- VLA15
- Developers
- Pfizer and Valneva
- Trial
- VALOR phase 3
- Participants
- More than 9,400 people aged five and older
- Efficacy
- More than 70%; up to 74.8% with booster doses
- EMA review
- Application validated on 13 August
What people are saying
The antibodies generated penetrate the intestine of the tick when it feeds on a person’s blood and neutralise the bacteria before it can be transmitted
These figures only reflect part of the burden of the disease because they do not include cases treated in primary care and many others that are never diagnosed