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# EMA accepts Pfizer-Valneva Lyme disease vaccine for review
- URL: https://www.pennystocks.news/valn-ema-accepts-pfizer-valneva-lyme-disease-vaccine-for-rev/
- Published: 2026-08-19T17:30:55.000Z
- Updated: 2026-08-25T01:39:33.000Z
- Description: The European Medicines Agency has accepted for formal review a marketing authorisation application for a Lyme disease vaccine developed by Pfizer and Valneva — a step that, if it ends in approval, would produce the first licensed Lyme vaccine for humans. Valneva shares closed
- Author: PennyStocksNews Team
- Tags: nasdaq, ticker-valn

The European Medicines Agency has accepted for formal review a marketing authorisation application for a Lyme disease vaccine developed by Pfizer and Valneva — a step that, if it ends in approval, would produce the first licensed Lyme vaccine for humans. Valneva shares closed 26.19% higher on August 14 after the companies announced the EMA's decision.

Valneva closed at $7.13, up from a previous close of $5.65\. Dollar volume was about $21.3 million across 44,722 trades. Short volume on the session was 217,892 shares, representing 53.74% of reported volume.

Valneva SE NASDAQ: VALN 

The application covers the vaccine candidate known as LB6V, a **six-valent OspA-based vaccine** — meaning it targets six distinct proteins found on the outer surface of the *Borrelia* bacteria that cause Lyme disease. The mechanism works at the tick stage: antibodies produced by a vaccinated person are ingested by the tick during feeding and block the bacterium from leaving the tick before it can be transmitted. The companies submitted the application on the basis of results from the Phase 3 VALOR trial, announced in March 2026, which reported **efficacy of more than 70%** against Lyme disease, with the vaccine described as well tolerated and with no safety concerns identified.

VALOR enrolled **9,437 participants aged five and older** at sites across the United States, Canada, and Europe in areas of high Lyme disease incidence. It was a randomised, placebo-controlled trial that gave participants four doses over two tick seasons. The EMA previously granted the vaccine candidate PRIME designation, a status reserved for medicines that may offer a major advantage over existing treatments — or, as here, address a condition with no approved therapy at all. There is currently no approved human Lyme disease vaccine anywhere in the world, according to the companies' release.

The disease burden in Europe is the core of the companies' case for approval. According to the August 14 release, Lyme disease is the most common vector-borne illness in Europe, with **about 132,000 cases reported annually** from countries with surveillance systems, and **more than 200 million people** living in areas of elevated risk. Left untreated, the disease can affect the joints, skin, nervous system, and heart.

Pfizer and Valneva have collaborated on the vaccine since **April 2020**, under an agreement that gives Pfizer exclusive rights to manufacture and commercialise the product if it receives regulatory clearance.

Valneva reported its first-half 2026 financial results the day before the EMA announcement. The company held a **cash position of €121.5 million** as of June 30, 2026, supported in part by **about €37 million in gross proceeds** from a capital raise completed in the second quarter. The company recorded a **net loss of €63.3 million** for the half, widened from the same period in 2025, driven partly by one-time charges related to its chikungunya vaccine IXCHIQ, including manufacturing contract cancellation fees and inventory write-offs. Valneva reaffirmed its full-year 2026 product sales guidance in the same release, and said regulatory decisions on the Lyme vaccine candidate are expected within the next twelve months.