Moderna’s Coronavirus Vaccine Begins Final-Stage Testing - The Wall Street Journal

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Moderna previously reported promising results of the first study of the vaccine.
Photo: Ted S. Warren/Associated Press

July 27, 2020 8:54 am ET

Moderna Inc. MRNA 4.92% said the pivotal study of its experimental coronavirus vaccine began Monday, with the first subjects receiving doses.

Researchers plan to enroll 30,000 people across the U.S. in the last-stage, or phase 3, trial of the Moderna vaccine candidate. Results will determine whether two doses protects against symptomatic Covid-19, and should be cleared for widespread use.

The company also received an additional commitment of up to $472 million from the federal government to support the large study, on top of the $483 million in funding earlier in the year for development, testing and preparations to manufacture at large-scale.

Moderna, which codesigned the vaccine with the National Institute of Allergy and Infectious Diseases, previously reported promising results of the first study of the vaccine, showing it induced immune responses and was generally safe in a small number of people.

The new phase 3 trial, titled Cove, is being conducted at nearly 90 sites in the U.S., including many in states where the virus has surged in recent weeks.

No vaccine has proven to work safely against the coronavirus. Many vaccines developed to target other pathogens have failed in testing, including in phase 3 trials.

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The start of the pivotal Moderna vaccine trial is the latest sign that the most advanced coronavirus vaccine candidates are moving into the final stages of testing, and could be ready for wider use before year’s end if results are positive.

A vaccine co-developed by the University of Oxford and AstraZeneca PLC started a large study in May in the U.K., and is due to enter a phase 3 study in the U.S. in August. A vaccine co-developed by Pfizer Inc. and BioNTech SE is due to start phase 3 testing this week.

Another company expected to be a major player in the vaccine hunt, Johnson & Johnson, is scheduled to start the first U.S. human study of its experimental shot Monday.

Moderna hopes its large study will yield positive results and possible vaccine availability in the fall, with J&J aiming for similar milestones by early 2021.