Moderna to start in July what could be first late-stage coronavirus vaccine trial.
Moderna, working together with the U.S. National Institutes of Health, will start in July a 30,000-person, placebo-controlled study of its experimental coronavirus vaccine, one of the most advanced candidates in the global race to develop a preventive treatment for COVID-19.
The Phase 3 trial's main goal, finalized after discussions with the Food and Drug Administration, will be to show whether Moderna's vaccine can prevent symptomatic coronavirus disease, the biotech said Thursday. Secondary measures will test the vaccine's effectiveness in keeping people from getting infected or from being hospitalized.
Moderna's study is one of three massive, late-stage vaccine trials that are expected to begin within the next few months. The tests, which will also involve candidates from AstraZeneca and Johnson & Johnson, are part of the U.S. government's exceedingly ambitious "Operation Warp Speed," which aims to bring a vaccine to market by early next year.
From the outset of coronavirus' spread around the world, Moderna has been a frontrunner in designing, constructing and putting into testing a vaccine for the virus, which has now infected more than 7 million people globally.
The Phase 3 study plans announced Thursday would keep Moderna at the forefront, and are the first to be detailed for any vaccine candidate.
The roughly 30,000-participant trial would be co-run by the National Institute of Allergy and Infectious Diseases, the agency that led the Phase 1 study of Moderna's vaccine, dubbed mRNA-1273.
Study volunteers would be randomized to receive either placebo or mRNA-1273, with an equal chance of getting either. Notably, the study's main goal won't be whether the vaccine prevents infection altogether, but rather whether mRNA-1273 stops people from developing COVID-19.
Moderna will use a 100 microgram dose of its vaccine, the higher of two doses now being tested in an ongoing Phase 2 trial. The company hopes that dose will maximize the sought-after immune response, while still being safe.
In the NIAID-run Phase 1 trial, volunteers given the 100 mg dose experienced mostly mild injection site reactions, while some people in a third, higher dose initially tested had severe fever-like symptoms.
But choosing the 100 mg dose will come at a cost. When Moderna signed a manufacturing deal with Swiss firm Lonza, it projected being able to make 1 billion doses each year, assuming a 50 mg dose. With the 100 mg dose now selected, Moderna said it and Lonza could make 500 million doses per year, and "possibly" up to 1 billion by next year.
So far, only snippets of data are available for Moderna's vaccine. Summary results released in a statement by the company indicated eight participants in the Phase 1 trial produced antibodies capable of neutralizing the coronavirus in test tubes.
It's unclear, however, how meaningful the immune response the vaccine produces is and how long it will last. The NIH is submitting the results from that initial study to a peer-reviewed medical journal, Moderna said Thursday.
More answers could come from the Phase 2 study currently underway. Moderna has fully enrolled a 300-participant group of adults between 18 and 54 years old, as well as a smaller 50-volunteer "sentinel" group of older adults that's meant to evaluate the vaccine's safety in a frailer population. Participants are receiving two shots of the 50 mg or 100 mg dose, or placebo. They'll be monitored for a year after the second vaccination.
Though Moderna is the first to detail a late-stage study, others should soon follow. The Wall Street Journal, citing an NIH researcher, reported earlier this week that AstraZeneca could start a Phase 3 trial of its vaccine in August, and J&J could follow in September.
For J&J, a target date of September is an acceleration of several months from its original plans, which had set September as the initial start of human testing. Now, J&J expects to begin a Phase 1 trial in the U.S. and Belgium sometime in the second half of July.
Author: Ben Fidler
Published: June 11, 2020 https://www.biopharmadive.com/news/moderna-coronavirus-vaccine-phase-3-trial/579622/