The FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine

Friday, December 18, 2020

Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). This innovative and monumental partnership has enabled NIH and Moderna to develop a safe and effective COVID-19 vaccine within the span of a year that will be manufactured and distributed across the U.S. The vaccine, called mRNA-1273, is a messenger RNA (mRNA) vaccine against COVID-19 encoding a prefusion stabilized form of the spike protein of SARS-CoV-2, co-developed by investigators from Moderna and NIAID's Vaccine Research Center. The approach to stabilize the coronavirus spike protein, called S-2P, was developed by NIAID scientists and their collaborators at Scripps Research, Dartmouth College and the University of Texas at Austin. NIAID supported the early development of the mRNA-1273 vaccine, and worked with Biomedical Advanced Research and Development Authority (BARDA) scientists to support the mid- and late-stages of clinical development, with BARDA leading government support of the scale-up of manufacturing and regulatory pathway to EUA. The mRNA-1273 vaccine is the second COVID-19 vaccine in the United States to be granted an EUA. NIH Director Francis S. Collins, M.D., Ph.D., NIAID Director Anthony S. Fauci, M.D., and BARDA Director Gary Disbrow, Ph.D. released the following statements:

"It has been less than a year since the world first learned of SARS-CoV-2 and the terrible disease it can cause. To have not one but two safe and highly effective COVID-19 vaccines ready for deployment to the American public is truly a remarkable scientific achievement, and a significant step toward ending the pandemic that has caused so much suffering. The partnership to develop the mRNA-1273 vaccine is a prime example of the tremendous good that can be accomplished when the public and private sectors work together to address a serious public health problem. It is through the dedicated efforts of our federal scientists and their collaborators at Moderna and in academia, the clinical staff who conducted the vaccine's rigorous clinical trials, and the tens of thousands of study participants who selflessly rolled up their sleeves, that another safe and highly effective vaccine to protect against COVID-19 will soon be rolled out to the American public." – NIH Director Francis S. Collins, M.D., Ph.D.

"Several years before SARS-CoV-2 entered the public consciousness, NIAID scientists were working with Moderna to develop vaccines for other coronaviruses. That existing scientific foundation is what enabled both partners to move quickly to develop the mRNA-1273 vaccine candidate against the novel SARS-CoV-2 coronavirus. NIAID conducted the initial Phase 1 testing of the vaccine and, with the support of BARDA and other Operation Warp Speed partners, played a central role in its large-scale clinical trial. Throughout each stage of clinical testing, the Moderna vaccine proved to be safe and highly effective at preventing symptomatic COVID-19. In a study of more than 30,000 people, it demonstrated 94% efficacy, and subsequent analyses have revealed that the vaccine induces a durable immune response. There is much we still do not know about SARS-CoV-2 and COVID-19. However, we do know that this vaccine is safe and can prevent symptomatic COVID-19 and severe disease. It is my hope that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward. " – NIAID Director Anthony S. Fauci, M.D.

"Today stands as a reminder of what can be accomplished when people come together to reach a common goal. We are working with a constant sense of urgency to bring vaccines, therapeutics and diagnostics to bear to end the crisis. As partners in Operation Warp Speed, NIAID and BARDA scientists collaborated with Moderna, adding BARDA's expertise in late-stage clinical trials, scale-up manufacturing and regulatory requirements. By collaborating, we were able to complete these steps in parallel and accelerate the development of a safe and effective vaccine. While we celebrate today's accomplishment, we recognize that there is still much work to do to ensure every American who wants a COVID-19 vaccine receives one. Every American has been touched in some way by this virus, and so we will continue to push forward. With continued collaboration and investment in scientific research, health security, and innovative public-private partnerships, we can achieve a safer, more prepared world." – BARDA Director Gary Disbrow, Ph.D.

Francis Collins, M.D., is Director of the National Institutes of Health in Bethesda, Maryland.

Anthony S. Fauci, M.D., is Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Gary Disbrow, Ph.D., is Director of the Biomedical Advanced Research and Development Authority (BARDA), in the HHS Office of the Assistant Secretary for Preparedness and Response.

Explore how we got to today: To learn more about the various milestones in the development of the NIH/Moderna vaccine and the robust portfolio of COVID-19 vaccines, visit BARDA's COVID-19 Response Timeline(link is external).

About Operation Warp Speed: OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

About HHS, ASPR, and BARDA: HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures(link is external) – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, BARDA-supported products have achieved 56 FDA approvals, licensures or clearances(link is external). To learn more about BARDA COVID-19 Portfolio(link is external) and  BARDA's COVID-19 Response (link is external), visit www.medicalcountermeasures.gov/(link is external)

About the National Institute of Allergy and Infectious Diseases: NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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