Final testing of COVID-19 vaccine to begin in July


Foreign Desk Report

CHICAGO: Moderna Inc (MRNA.O) on Thursday confirmed it plans to start a trial of 30,000 volunteers of its much-anticipated coronavirus vaccine in July as the company enters the final stage of testing.
The Cambridge, Massachusetts-based biotech said the primary goal of the study would be to prevent symptomatic COVID-19, the disease caused by the novel coronavirus. The key secondary goal would be prevention of severe disease, as defined by keeping people out of the hospital.
The company’s shares jumped 6 percent in premarket trading.
Moderna said it has selected the 100-microgram dose of the vaccine for the late-stage study. At that dose level, the company is on track to deliver about 500 million doses per year, and possibly up to 1 billion doses per year, starting in 2021 from the company’s internal U.S. manufacturing site and strategic collaboration with Swiss drugmaker Lonza (LONN.S).
The company said it chose the 100-microgram dose to maximize the immune response and minimize adverse reactions. Moderna said is has completed manufacturing of enough vaccine to start the phase 3 trial. In the midstage study, the company said it has enrolled 300 healthy adults, who have each been dosed with at least one shot, as well as the first 50 older adults, aged 18 to 54.
Testing the vaccine in older adults with be critical because this group is at higher risk for the most severe effects of the virus, and older adults typically have less efficient immune function. The midstage study is testing the safety and preliminary effectiveness of two doses of the vaccine given 28 days apart. Study participants will be followed for a year.
Johnson & Johnson moved up the start of human clinical trials for its experimental vaccine against the highly contagious coronavirus by two months to the second half of July as the drugmaker rushes to develop prevention for Covid-19, the company said on Wednesday.
The acceleration should allow J&J to take part in the massive clinical trials program planned by the US government, which aims to have an effective vaccine by year end. J&J shares rose nearly 2 percent to $148.69.
Last March, J&J signed deals with the US government to create enough manufacturing capacity to produce more than 1 billion doses of its vaccine through 2021 even before it has evidence that it works.
There are currently no US approved treatments or vaccines for the virus. A vaccine is seen as essential to ending the pandemic that has infected more than 7.2 million people and killed over 412,000 globally, while battering economies worldwide.
J&J initially expected safety trials to start in September. Chief Scientific Officer Paul Stoffels told Reuters the company has been working closely with its US government partners to accelerate that timeline.