“Quite Good” Moderna Vaccine Starts Phase 3 Trial on July 27, 2020

(p. A6) New details about the first human study of Moderna Inc.’s experimental coronavirus vaccine emerged Tuesday, which researchers said reinforced their decision to take the shot into a large, decisive clinical trial scheduled to start in late July [2020].

The new results, published online by the New England Journal of Medicine, showed that the vaccine induced the desired immune response for all 45 people evaluated—a larger group than in the preliminary data Moderna released in May—and was generally safe and well-tolerated.

“This is really quite good news,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview Tuesday. NIAID co-developed the Moderna vaccine and led the study.

“The gold standard of protection against a viral infection is neutralizing antibodies,” he added. “And the data from the study, small numbers as it may be, are pretty clear that this vaccine is capable of inducing quite good [levels] of neutralizing antibodies.”

Researchers said they found no serious safety risks, though some participants had injection-site pain and symptoms such as fatigue, headache and chills.

Dr. Fauci said it is possible that the coming large study would yield an answer by year-end about whether the vaccine induced immune responses sufficient to protect people safely from Covid-19. A positive answer would clear the way for wider use and potentially help curb the deadly pandemic.

The new “Cove” study, scheduled to start July 27, will aim to enroll about 30,000 adults at nearly 90 different U.S. locations.

For the full story, see:

Loftus, Peter. “Data Show Vaccine Is Ready for Big Trial.” The Wall Street Journal (Weds., July 15, 2020): A6.

(Note: bracketed year added.)

(Note: the online version of the story was updated June 14, 2020, and has the title “Moderna’s Covid-19 Vaccine Moves to Bigger Study.”)

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