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.

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