Policy Center

Expanded access policy

Novavax promotes improved health by discovering, developing, and commercializing innovative vaccines to protect against serious infectious diseases. We offer a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response.  

Our vaccines are designed to be used prophylactically, meaning that they are designed and intended to prevent disease in healthy individuals, not for the treatment of existing disease. Like all vaccines, our products must be carefully evaluated in clinical trials to ensure that they can be used safely and effectively.  

We understand that patients, caregivers, or healthcare professionals may wish to have access to our vaccine candidates before they receive regulatory approval, outside the context of a clinical trial. At the present time, we are not making our products available for such pre-approval access.  This includes requests for pre-approval access under section 561(b) of the Federal Food, Drug, and Cosmetic Act, the Right to Try Act of 2017 (Pub. L. No. 115-176), or any state laws.  We believe that participation in clinical trials, with their established eligibility criteria and ethical safeguards, is the most appropriate and equitable approach to making our investigational vaccines available before they are approved.    

Novavax may revisit this policy as we gain additional scientific knowledge about our vaccine products through clinical trial data and real-world use after vaccine licensure or authorization, or if we develop therapeutic products in the future. Any such changes will be posted to this site.    

You can find information about ongoing clinical trials of our vaccines by visiting www.clinicaltrials.gov and entering “Novavax” in the “other terms” search box.  Any inquiries regarding this policy should be directed to https://www.novavax.com/contact-us.  Novavax expects to acknowledge any such inquiries from patients, caregivers, or healthcare professionals within five business days.