CHICAGO (Reuters) – Moderna Inc (MRNA.O) confirmed on Thursday its intention to start a trial of 30,000 volunteers for its highly anticipated coronavirus vaccine in July as the company enters the final phase of testing.
Cambridge, Massachusetts-based biotechnology said the primary goal of the study would be to prevent symptomatic COVID-19, the disease caused by the new coronavirus. The main secondary objective would be the prevention of serious illnesses, as defined by preventing patients from leaving the hospital.
The company’s shares jumped 6% in trade before marketing.
Moderna said it selected the 100 microgram dose of the vaccine for the advanced stage study. At this dose level, the company is on track to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021 from the company’s internal manufacturing site to United States and a strategic collaboration with the Swiss drug manufacturer Lonza (LONN.S).
The company said it chose the 100 microgram dose to maximize the immune response and minimize side effects.
Moderna said it had finished manufacturing enough vaccines to start the phase 3 trial.
In the mid-term study, the company said it recruited 300 healthy adults, each of whom received at least one injection, as well as the first 50 elderly people, ages 18 to 54.
Testing the vaccine in the elderly should be critical as this group is at higher risk for the more serious effects of the virus, and the elderly generally have less effective immune function. The mid-term study is testing the safety and efficacy of two doses of the vaccine given 28 days apart.
Study participants will be followed for one year.
Report by Julie Steenhuysen; Editing by Bernadette Baum and Nick Zieminski
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