US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its Covid-19 vaccine on July 27, to test how well it protects people in the real world.
The trial will enroll 30,000 participants across 87 locations, according to the website. Participants in the experimental arm will receive a 100 microgram dose of the potential vaccine on the first day and another 29 days later. Some patients will also receive a placebo.
Moderna’s experimental vaccine contains genetic material called messenger RNA, or mRNA.
The mRNA is a genetic code that tells cells what to build — in this case, an antigen that may induce an immune response to the virus. It became the first candidate to enter a phase one human trial in March.
There’s no guarantee but the government hopes to have results around the end of the year — record-setting speed for developing a vaccine.
The vaccine requires two doses, a month apart.
There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren’t uncommon with other vaccines — fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn’t being pursued.
Moderna’s share price jumped nearly 15 percent in trading after U.S. markets closed. Shares of the company, based in Cambridge, Massachusetts, have nearly quadrupled this year.
The 30,000-person study will mark the world’s largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn’t the only one set for such massive U.S. testing, crucial to spot rare side effects.
The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.
Already, people can start signing up to volunteer for the different studies.
People think “this is a race for one winner. Me, I’m cheering every one of them on,” said Fauci, who directs NIH’s National Institute of Allergy and Infectious Diseases.
“We need multiple vaccines. We need vaccines for the world, not only for our own country.”