Home Health News Coronavirus Vaccine Begins Final Phase Of Testing In The U.S. – Forbes

Coronavirus Vaccine Begins Final Phase Of Testing In The U.S. – Forbes

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TOPLINE

The Covid-19 vaccine candidate made by the biotech company Moderna, Inc. and developed in collaboration with the National Institutes of Health begins Phase 3 clinical trials on Monday, the first such final-phase testing trial of a coronavirus vaccine in the U.S., carrying with it the hope that it can help combat a pandemic which has crippled the nation over the past four-plus months.

KEY FACTS

According to Moderna, the trial will be conducted at nearly 100 U.S. research sites, with the first patient dosed at a site in Savannah, Georgia, on Monday morning.

30,000 Americans have reportedly volunteered to be part of the large phase three human trial.

Volunteers will receive either two 100 microgram injections of the vaccine, called mRNA-1273, or a placebo about 28 days apart, with participants unaware of which dose they received.

Results from Phase 1 testing of the Moderna vaccine, published in the New England Journal of Medicine two weeks ago, were considered “promising,” as it triggered an immune response with mostly mild side effects.

Moderna CEO Stephane Bancel said Monday morning that late-stage results could be ready by October, but cautioned that was a “really optimistic” scenario.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Monday he is “not particularly concerned” about the safety risk of the vaccine, even though it utilizes relatively new technology to fight the virus.

Key Background:

According to the World Health Organization, there are 25 vaccine candidates in clinical trials around the world. The Moderna/NIH vaccine is one of only five vaccine candidates to reach the final phase (Phase 3) of testing. Three of the other four vaccines have been engineered in China. The other candidate is the product of a collaboration between the University of Oxford and AstraZeneca. Moderna is one of numerous U.S. companies that has received funding from Operation Warp Speed, the federal government’s coronavirus vaccine program. Over the weekend, Moderna announced it had received an additional $472 million from the Biomedical Advanced Research and Development Authority for Phase 3 study, bringing the total to $955 million.

Critical Quote:

“We’re optimistic, cautiously optimistic” that the vaccine will work and that “toward the end of the year,” there will be data to prove it, Dr. Stephen Hoge, president of Moderna, told a House subcommittee last week.

Big Number:

4.2 million: As of Monday morning, more than 4,244,600 people in the United States have been infected with Covid-19, and at least 146,700 have died, according to a New York Times database.

Further Reading:

Virus vaccine put to final test in thousands of volunteers (AP)

COVID-19 Vaccine Candidate Heads To Widespread Testing In U.S. (NPR)  

5 Coronavirus Questions That Will Keep You Safer, More Informed (Forbes) 

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