Moderna’s mRNA Vaccine Against COVID-19 Receives FDA Emergency Use Authorization
The Moderna COVID-19 Vaccine has been authorized for emergency use by the FDA in individuals 18 years of age and older. It has not been approved or licensed by FDA. The emergency use of the Moderna COVID-19 Vaccine is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of this product unless the declaration is terminated or authorization revoked sooner.
Today, the U.S. Food and Drug Administration (FDA) has authorized the emergency use of the Moderna COVID-19 Vaccine. This marks a bright spot in a year defined by the biggest public health crisis of our lives, disruption, uncertainty and loss for many of us, and a significant milestone in our fight against the pandemic virus.
Since early January, we have chased this virus with the intent to protect as many people around the world as possible. We always worried about the fall/winter second wave given it is a respiratory virus. All along, we have known that each day matters.
It took the power of science, human ingenuity and relentless determination to get here.
Moderna’s journey started 10 years ago with a revolutionary, but unproven, concept that messenger RNA, mRNA, might become the basis for a transformative approach to developing medicines. Prior to our development of the Moderna COVID-19 Vaccine, we had enrolled more than 2,000 healthy volunteers across nine clinical trials for mRNA vaccines, including four first-in-class vaccine candidates, since entering the clinic in December 2015.
It was this experience, along with our large mRNA technology platform, deep expertise in mRNA science, early investment in manufacturing and digital, and strategic alliances that uniquely positioned us to respond to the COVID-19 pandemic quickly.
We said from the very beginning that there is no world where we can maximize our impact on patients by going it alone. This day is only possible because of the hard work and sacrifices of so many.
I am extremely proud of what the Moderna team has achieved with our partners. We went from the release of the genetic sequence for the virus online to FDA emergency use authorization (EUA) in only 11 months, while completing a Phase 1, a Phase 2 and a 30,000 participant, placebo-controlled Phase 3 trial.
We are indebted to all of the participants in our studies. They are the true heroes of this journey. I would also like to thank the clinical investigators and our partners at the clinical trial sites, including those from PPD and the National Institutes of Health (NIH), as well as the site staff who have been on the frontlines of the fight against the virus. They are an inspiration to us all.
I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of pre-clinical research on potential pandemic threats at the Vaccine Research Center (VRC) that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I also want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point. Their help, guidance and partnership has been instrumental in us bringing this vaccine to an EUA where it could help protect millions.
Thank you to the teams of the many regulatory agencies (U.S. FDA, Health Canada, European Medicines Agency, MHRA in the UK, Swissmedic, Ministry of Health of Singapore, Ministry of Health, Labour and Welfare of Japan, Ministry of Health of Israel and others) for their incredible partnership and clear guidance this year. I have had the privilege to work in this industry for 25 years. I have never seen such collaboration, 24/7 engagement and relentless work to get the job done, without any compromise on safety or proper enforcement of regulations. My hat is off to them.
Thank you to all of our suppliers and partners including Charles River Laboratories, PPD, Lonza, Catalent and ROVI for their collaboration. We value these partnerships as we work tirelessly across research, development and manufacturing of the vaccine.
We are thankful for the trust the governments around the world have placed in us to deliver a vaccine for their countries. And to the communities in which we live and work, in Massachusetts and beyond, we deeply appreciate all the well wishes and support.
Thank you to our investors who have provided capital so that we can continue to build the best possible version of Moderna. They, like us, thought it was a worthwhile endeavor to try to make mRNA a new class of medicines. It was risky, but if we could get there, it would transform medicine forever. I also want to thank the financial analyst and media communities for their partnership.
I want to thank the Moderna team. Our remarkable team is the engine behind everything we have been able to accomplish with the Moderna COVID-19 Vaccine and the driving force behind our progress and our culture. I am in awe of their ability to rise to this momentous challenge. Thank you for the unbridled curiosity, bold spirit and relentless commitment to our Mission for patients. My gratitude to you and your families for the many sacrifices over the years, but especially in 2020—the dinners with family missed, the late-evening calls, the weekend meetings. This year felt like running a two-hour marathon, and I am so thankful and proud of what you have accomplished.
Finally, I would like to thank my executive team for their tremendous teamwork, collaboration and ability to get the job done. The Moderna Board has also been instrumental in enabling the team to get the resources we needed and to take the calculated risks needed to deliver on our Mission.
We remain committed to doing our part to help end the COVID-19 pandemic. Our continued focus is on scaling up manufacturing and ensuring we can get as many high-quality doses of the vaccine as we can to help protect as many people as we can.
Thank you to everyone who has been on this 10-year scientific, entrepreneurial and medical journey with us. Your trust and support helped make today possible.
I am excited and humbled by the opportunity to bring a new class of medicines to patients and I believe this milestone, along with our recent advances, has put us closer than ever before to that ultimate goal: launching several first-in-class medicines where there are no treatments today.
This is just the beginning.
Wishing every one of you a healthy and safe holiday season.
Warmest regards,
Stéphane Bancel
Chief Executive Officer