---
title: "European Regulator Validates Pfizer and Valneva's Lyme Disease Vaccine Application"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/295959393.md"
description: "Valneva (VALN) stock surged nearly 25% after the European Medicines Agency validated the Marketing Authorization Application for its Lyme disease vaccine candidate, PF-07307405, co-developed with Pfizer. The EMA will now assess the application, which is supported by Phase 3 trial data showing over 70% efficacy and no safety concerns."
datetime: "2026-08-14T16:46:14.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/295959393.md)
  - [en](https://longbridge.com/en/news/295959393.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/295959393.md)
generator: "portal-rs"
---

# European Regulator Validates Pfizer and Valneva's Lyme Disease Vaccine Application

**Valneva SE** (NASDAQ:VALN) stock is surging on Friday after the company and its partner **Pfizer Inc.** (NYSE:PFE) announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, their Lyme disease vaccine candidate.

The EMA will now commence its assessment of the application.

## Clinical Trial Results

The application for PF-07307405 is supported by encouraging efficacy data from the Phase 3 VALOR clinical trial.

The trial evaluated the vaccine candidate’s ability to prevent Lyme disease in individuals aged five and older. The results demonstrated an efficacy of over 70%.

Furthermore, the vaccine was well-tolerated among trial participants, with no safety concerns reported.

 **Read Also: Valneva Steps Back From US Approval Bid For Chikungunya Vaccine** 

In March, the companies released topline results from the Phase 3 VALOR clinical trial for its Lyme disease vaccine candidate, which did not meet the primary endpoint criteria.

The Phase 3 VALOR trial results showed that fewer Lyme disease cases were accrued than anticipated, and the primary endpoint was not met in the first analysis.

## Collaborative Effort

PF-07307405 was developed through a collaboration between Pfizer and Valneva. The vaccine candidate has undergone rigorous evaluation for its efficacy, safety, tolerability, immunogenicity, and manufacturing lot consistency.

The two companies entered into a collaboration and license agreement in April 2020. Under this agreement, they are co-developing PF-07307405, and Pfizer holds the exclusive rights to manufacture and commercialize the vaccine, pending regulatory approval.

**VALN Stock Price Activity**: Valneva shares were up 24.96% at $7.06 at the time of publication on Friday,  
according to Benzinga Pro data.

*Photo: Shutterstock*

 **Read Also: Equinix Vs. Digital Realty: Why Dividend Payout Ratios Aren't Created Equal**

### Related Stocks

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

## Related News & Research

- [Prediction: This Is Where Pfizer Stock Will Be in 2030](https://longbridge.com/en/news/296683959.md)
- [EMA validates Pfizer and Valneva’s Lyme disease vaccine](https://longbridge.com/en/news/296088348.md)
- [Pfizer Inc. $PFE Shares Bought by Farther Finance Advisors LLC](https://longbridge.com/en/news/296071335.md)
- [BUZZ-Street View: Growth drugs lift Pfizer outlook, but execution remains key](https://longbridge.com/en/news/294968791.md)
- [Pfizer Earnings Reveal New Engine Beyond Covid](https://longbridge.com/en/news/294862271.md)

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