Expanded Access Policy
Bavarian Nordic is committed to developing new vaccines for the treatment of various serious and life-threatening diseases. We believe that the best way for patients to access our investigational products is through clinical trials designed to evaluate safety and efficacy. Bavarian Nordic strives to partner with world-class medical experts in our respective fields of clinical trial investigation. It is through these trials that patients receive current standard of care as well as the possibility of our experimental therapies.
Another method of patient access to investigational products for serious or life-threatening diseases when there are no other treatment options available is through expanded access trials, also referred to as compassionate use trials.
In general, Bavarian Nordic is not accepting proposals for expanded access. Exceptionally and if vaccines are still available for use, Bavarian Nordic will evaluate and at its sole discretion decide on a case by case basis HCP requests for expanded access of its immune-oncology experimental vaccines for subjects who experienced significant clinical benefit in BN-sponsored clinical programs
Information on applicable Bavarian Nordic sponsored trials as well as investigator-sponsored trials can be found here. As our clinical programs mature and we obtain clinical evidence of safety and effectiveness, typically from Phase 3 trial results, Bavarian Nordic will re-evaluate this policy.
For further questions about Bavarian Nordic’s expanded access policy, please contact us. We will respectfully acknowledge your request within 10 days of receipt.