Moderna is working to deliver on the promise of mRNA science to create a new class of medicines for patients. As we advance our pipeline, patients, caregivers and healthcare providers may seek access to our investigational medicines outside of clinical trials and prior to regulatory approval. We understand the need for new therapies and the urgency behind requests for pre-approval access*.
While we continue evaluating the safety and effectiveness of this potential new class of medicines in clinical trials, we are not providing access to our investigational mRNA therapies or vaccines outside of these studies. We believe that participation in a clinical trial is the most appropriate way for patients to access any of our investigational treatments. We also believe that participation in clinical trials is the most efficient path to providing access to the greatest number of patients in need of a new therapy. Should our policy change over time, we will post updates on this site.
You can find links to information about our ongoing clinical trials on our website or go directly to www.clinicaltrials.gov and enter “Moderna” into the “other terms” search box. Please speak with your physician or contact us at email@example.com if you have any additional questions about our clinical trials or this policy. Our team plans to acknowledge receipt of requests sent to this email address from patients, families and healthcare providers within 5 business days.
*Includes requests for access under section 561(b) of the Federal Food, Drug, and Cosmetic Act, as well as ‘Right to Try’ legislation (Public law no. 115-176).