NIH & BARDA react to emergency use authorisation of Moderna Covid-19 vaccine by FDA

"To have not one but two safe and highly effective vaccines ready for deployment to the American public is truly a remarkable scientific achievement"


Covid-19 vaccineNIH and BARDA have reacted to the United States Food and Drug Administration’s Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its Covid-19 vaccine.

The vaccine was co-developed with scientists at the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID).

In a statement, NIH Director Francis S. Collins, said, “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.”

Collins added that 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.

NIAID Director Anthony S. Fauci, said, “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.”

He further stated that 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 per cent efficacy, and subsequent analyses have revealed that the vaccine induces a durable immune response.

Common goal

BARDA Director Gary Disbrow said, “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.”

He also said that by collaborating, they were able to complete these steps in parallel and accelerate the development of a safe and effective vaccine.

Called mRNA-1273, the vaccine is a messenger RNA (mRNA) vaccine against COVID-19 encoding a prefusion stabilised form of the spike protein of SARS-CoV-2, co-developed by investigators from Moderna and NIAID’s Vaccine Research Center.

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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.

(With inputs from The OnLook News Research Bureau)

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