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Moderna vaccine candidate shows 94.5% efficacy against COVID-19

Two vaccines and two therapeutics may be approved before the end of the year.

Susan Morse, Managing Editor

Moderna's COVID-19 vaccine shows an efficacy of 94.5%, the biotech company announced today.

The Moderna vaccine candidate is now the second to show the potential for very high efficacy in Phase 3 trials. Last week Pfizer announced it had developed a vaccine that was 90% effective.

The National Institutes of Health's review of data from Moderna's investigational COVID-19 vaccine suggests that it is safe and highly effective at preventing symptomatic COVID-19 in adults, Health and Human Services Secretary Alex Azar said.

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The independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, shows the trial has met the statistical criteria prespecified in the study protocol for efficacy, with a vaccine efficacy of 94.5%, the company said. 

This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

THERAPEUTICS

In therapeutics, Eli Lilly's investigational Monoclonal Antibody therapeutic bamlanivimab received emergency use authorization for the treatment of mild to moderate COVID-19 outpatients who are at high risk of progressing to severe COVID-19 or hospitalization.

HHS announced its allocation plan for initial doses of bamlanivimab to state and territorial health departments, which in turn will determine which healthcare facilities will receive the infusion drug. Eighty thousand doses were shipped to locations determined by states, and patients have already begun receiving the therapeutic.

WHY THIS MATTERS 

A vaccine is seen as the most effective method to stop the pandemic, which has surged in recent weeks as people move inside during the colder weather.

Therapeutics have shown success in treating those with COVID-19.

The two vaccines and two therapeutics may be approved before the end of the year.

Operation Warp Speed Chief Scientific Advisor Dr. Moncef Slaoui said during a news conference on Friday that it is hoped that the two vaccines in clinical trials can file for emergency use authorization in the next few weeks, for use in December.

A large number of Americans may be able to be immunized in February and March, he said. 

On Friday afternoon, President Donald Trump, in his first news conference since the election, released accomplishments of Operation Warp Speed, the government's initiative towards a COVID-19 vaccine.

The president took no questions and only alluded to the election in talking about the future availability of a vaccine.
 
"Which administration it will be, time will tell," Trump said. 

The president took no questions.

THE LARGER TREND

Operation Warp Speed has provided $1.95 billion in funding that will support purchasing millions of doses, which will first be distributed to frontline workers, those at high risk and the elderly.

The government has partnered with large chain pharmacies and networks that represent independent pharmacies and regional chains to increase access to a COVID-19 vaccine once it is authorized for distribution. The partnership brings about 60% of the nation's pharmacies into the federal pharmacy program.

Operation Warp Speed 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.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com