Bavarian Nordic A/S (CPH:BAVA) has initiated a pivotal phase 3 trial of the freeze-dried formulation of MVA-BN smallpox vaccine in 1,110 healthy, vaccinia-naïve subjects, the company announced on Wednesday.

This randomised, double-blind, multicentre trial will evaluate the immunogenicity and safety of three consecutive vaccine lots of the freeze-dried formulation of MVA-BN smallpox vaccine, similar to the prior completed phase 3 study for the liquid-frozen MVA-BN formulation.

Reportedly, the Biologics License Application (BLA) for the liquid frozen formulation of MVA-BN is currently under review at the US FDA, with anticipated completion and licensure in the second half of 2019.

Upon completion of the current study, expected in 2021, the company intends to submit a supplement to the BLA to extend the approval for both formulations of MVA-BN.

The requirement for only one phase 3 study of the freeze-dried formulation was confirmed at an end-of-phase 2 meeting with the regulatory authorities, following a prior phase 2 study showing bioequivalence between the freeze-dried and liquid-frozen formulations of MVA-BN.

Based on the successful completion of the study and subsequent regulatory process, the company anticipates approval of the freeze-dried vaccine in 2022.

According to the company, this phase 3 study and regulatory activities towards licensure are funded through an option valued at USD37m, which was exercised in November 2017 as part of the ongoing USD539m contract with the Biomedical Advanced Research and Development Authority (BARDA) for development and supply of freeze-dried MVA-BN to the US Strategic National Stockpile.

Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative therapies against cancer and infectious diseases.