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NIH Statement on Approval of the Moderna COVID Vaccine

12/25/2020

The Moderna COVID vaccine designated mRNA-1273 approved  by the FDA on Friday December 18th was developed as a joint venture between the National Institute of Health and Moderna Inc.  Collaborating scientists at Scripps Research, Dartmouth College and the University of Texas in Austin also contributed to the development of the vaccine.  The product comprises stabilized mRNA in a polyethylene glycol nanoparticle encoding for a spike protein of the SARS-COV-2 virus (S-2P). This mRNA is capable of stimulating production of the spike protein by the recipient that in turn stimulates production of specific antibodies.


Drs Collins (left) and Fauci (right)

 

The National Institute of Allergy and Infectious Diseases supported the early development of the Moderna vaccine and worked with the Biomedical Advanced Research and Development Authority (BARDA) to initiate clinical development and subsequent scale-up of manufacturing leading to FDA approval.

 

In a joint statement, the Director of the National Institutes of Health, Dr. Francis S. Collins noted, “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 be available to the American public.”

 

Director of the NIAID, Dr. Anthony S. Fauci stated, “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 product becomes available to them. That is how our country will begin to heal and move forward.” 

 

Director of BARDA, Gary Disbrow opined, “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 expertise in late-stage clinical trials, scale-up manufacturing and regulatory requirements.”