One of the first biotech companies to begin human trials of an experimental vaccine for the coronavirus is now ready to move onto the next phase of testing.
On Thursday, Moderna announced that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people.
“The imminent Phase 2 study start is a crucial step forward,” Stéphane Bancel, Moderna’s chief executive, said in a statement.
The main goal of this set of tests is to find out if the vaccine is safe and if positive results from the first few dozen volunteers in the first phase can be replicated in a much larger group. If it is successful, later studies, known as Phase 3 trials, will determine exactly how well the vaccine works.
More than a dozen companies, including known vaccine producers like Johnson & Johnson, or Sanofi, are involved in a global race to develop a vaccine to tamp down the highly infectious coronavirus that has killed more than a quarter-million people around the world.
Four Chinese companies have started testing their potential vaccines on humans, including CanSino Biologics, which announced the beginning of Phase 2 trials in early April. A few others, such as Pfizer and its German partner, BioNTech, are enrolling volunteers for combined Phase 1 and 2 trials.
Dr. Anthony Fauci, the nation’s leading expert on infectious diseases, has suggested that it would still take 12 to 18 months for a vaccine to be widely available to the public. There is no proven treatment, and many researchers and corporations around the world are pursuing remedies in addition to vaccines.
Moderna’s vaccine candidate, called mRNA-1273, relies on genetic material known as messenger RNA, which carries the recipe for making proteins to tiny ribosome chefs inside cells. The vaccine is written with a very specific recipe — in this case for making the spike protein of the coronavirus.
Because the virus typically uses this protein as a key to unlock and take over lung cells, the vaccine could train a healthy immune system to produce antibodies to fight off an infection before someone gets sick.
Moderna’s vaccine is one of many using this unusual technology. Its first tests in humans were conducted in 45 healthy adults in Seattle, funded by the National Institutes of Health. Since then, other companies, using different approaches, have also joined the race to find a coronavirus vaccine.
The F.D.A. said its policy was not to comment on phases of any drug trial, and Moderna did not release results from the first phase.
In its first-quarter update on Thursday, Moderna appeared to be speeding up its timeline for a coronavirus vaccine, stating that the next phase would begin “shortly.” The company is also gearing up for a Phase 3 trial in the summer, and hopes to have the final vaccine approved “as soon as 2021.”
Moderna’s shares soared as much as 13 percent in early Thursday trading. Excitement over a potential vaccine has led to an increase of more than 150 percent in the company’s stock since the beginning of this year.
The biotech firm is also accelerating plans for manufacturing a vaccine so it can start building a stockpile as soon as this July. Last week, the firm announced a 10-year collaboration with the Swiss contract drugmaker Lonza to manufacture up to one billion doses per year for worldwide distribution, if the vaccine proves successful.
