---
title: "EMA validates Pfizer and Valneva’s Lyme disease vaccine"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/296088348.md"
description: "The European Medicines Agency (EMA) has validated the Lyme disease vaccine application submitted by Pfizer and Valneva, initiating a formal assessment. The submission relies on Phase III VALOR trial data involving over 9,400 participants, showing efficacy exceeding 70% and a favorable safety profile. This marks a significant step toward potentially launching Europe's first Lyme disease vaccine, addressing a common vector-borne illness affecting over 100,000 people annually."
datetime: "2026-08-17T10:01:39.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/296088348.md)
  - [en](https://longbridge.com/en/news/296088348.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/296088348.md)
generator: "portal-rs"
---

# EMA validates Pfizer and Valneva’s Lyme disease vaccine

With this validation, the agency will begin its formal assessment of the application.

The submission is supported by efficacy and safety data from the Phase III VALOR clinical trial, which enrolled 9,437 participants aged five years and above across the US, Canada, and Europe.

In the study, PF-07307405 showed efficacy of more than 70% in preventing Lyme disease. The vaccine candidate was found to be well tolerated with no identified safety concerns, according to the companies.

Pfizer senior vice-president and chief vaccines officer Annaliesa Anderson said: “I’m proud of the progress we have made with our Lyme disease vaccine candidate and excited about the opportunity to potentially bring the first vaccine of its kind to Europe. I look forward to collaborating with the EMA as this vaccine candidate advances through the review cycle.”

“Lyme disease remains the most common vector-borne illness in Europe, affecting more than 100,000 people each year. When left untreated, it can lead to serious and potentially long-lasting complications involving the skin, joints, nervous system, and heart.

“We believe vaccination has the potential to provide an important new layer of protection against this debilitating disease and help people continue to enjoy the outdoors with greater confidence.”

Pfizer and Valneva began collaborating on PF-07307405 in April 2020, with the former holding exclusive manufacturing and commercialisation rights if regulatory approval is achieved.

The vaccine is a 6-valent outer surface protein A (OspA)-based protein subunit, targeting six Borrelia OspA serotypes found in North America and Europe.

Currently, no approved human vaccines exist for Lyme disease.

In June 2026, Pfizerreceived approvalfrom the US Food and Drug Administration for an expanded indication of Hympavzi (marstacimab-hncq) to treat haemophilia A or B.

The post EMA validates Pfizer and Valneva’s Lyme disease vaccine appeared first on Pharmaceutical Business review.

### Related Stocks

- [VALN.US](https://longbridge.com/en/quote/VALN.US.md)
- [PFE.US](https://longbridge.com/en/quote/PFE.US.md)

## Related News & Research

- [European Regulator Validates Pfizer and Valneva's Lyme Disease Vaccine Application](https://longbridge.com/en/news/295959393.md)
- [Prediction: This Is Where Pfizer Stock Will Be in 2030](https://longbridge.com/en/news/296683959.md)
- [Pfizer Inc. $PFE Shares Bought by Farther Finance Advisors LLC](https://longbridge.com/en/news/296071335.md)
- [Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency | PFE Stock News](https://longbridge.com/en/news/295884147.md)
- [Sunshine Guojian Releases 2026 Interim Report:](https://longbridge.com/en/news/296547265.md)

---
> **Disclaimer: This article is for reference only and does not constitute any investment advice.**