Moderna enrolls final volunteers into key coronavirus vaccine study.
Moderna has fully enrolled the late-stage study testing its experimental coronavirus vaccine, recruiting 30,000 volunteers from across America in just three months as the company presses forward in an extraordinary push to quickly prove its shot can prevent COVID-19.
More than 25,000 of those study participants have now received their second and final dose of Moderna's vaccine, and the company expects to have preliminary data from the trial by next month. In a statement Thursday, Moderna said it would decide whether to ask for emergency clearance once a median of two months of safety data are collected, meeting a standard recently set by the Food and Drug Administration.
Moderna was the first U.S. drugmaker to begin testing a coronavirus vaccine in humans, working with government scientists to design and develop a candidate that's now among the most advanced globally. Several other vaccine developers, including Pfizer and partner BioNTech, are similarly close to delivering results from the final stage of clinical testing.
When Moderna began research on a vaccine for the virus now known as SARS-CoV-2 in late January, confirmed cases of infection were largely contained within China and the public health catastrophe that's since unfolded was a threat, not reality.
The prospect of designing, testing, and proving a vaccine within a year — a timeline never before achieved — was similarly remote.
Moderna has yet to accomplish that goal, with the trial that's now fully enrolled being the crucial test of whether its vaccine can prevent coronavirus disease or infection. But the progress it and others have made to get to this point is still a scientific achievement with few modern parallels.
In Moderna's case, the company has been aided by more than a billion dollars of government funding, as well as the assistance of researchers and supporting companies in the U.S. and overseas.
Government support has been critical, too, in the rapid advancement of vaccines from Johnson & Johnson, AstraZeneca and Novavax, all of which are now in late-stage testing. Pfizer has eschewed direct U.S. support for its vaccine testing, although the U.S. has agreed to pay nearly $2 billion for initial doses of the shot. Pfizer's development partner BioNTech, based in Mainz, Germany, has received money from the German government.
Moderna is the first to fully enroll its Phase 3 trial, although Pfizer and BioNTech have recruited more volunteers to date into their larger study, which will eventually involve some 44,000 participants. In both studies, half of volunteers receive the study vaccine and half receive placebo.
More than 7,000 of the participants in Moderna's trial, called COVE, are over 65, and more than 5,000 younger than 65 have chronic diseases like diabetes, obesity and heart disease that put them at higher risk of severe COVID-19.
Moderna also made the decision in September to slow down enrollment so more people of color, particularly those who identify as Black or Hispanic or Latino, could be recruited. The impact of the COVID-19 pandemic has been much more severe among those groups, and their participation in trials is seen as critical for the success of any nationwide vaccination campaign that may follow.
Just over a third of the participants in Moderna's study were from communities of color, including roughly 6,000 people who identify as Hispanic or Latino, and about 3,000 who identify as Black or African American.
Volunteers in the study came from 30 states and the District of Columbia, with many recruited at sites in Texas, California and Florida.
Like other developers, the researchers running Moderna's study are tracking cases of COVID-19 among those who received the vaccine and those who got placebo. At certain points, a trial committee will review the data to check whether vaccination is both safe and effective. In Moderna's study, these "interim" analyses are set to occur when 53 and 106 cases have occurred.
Moderna expects the first data from the COVE trial will be available in November and, if positive, the company expects to then ask the FDA for emergency clearance.
Pfizer, which is still enrolling its study, will likely read out results first. Company CEO Albert Bourla has repeatedly said efficacy data could come by the end of this month, although Pfizer would not ask for emergency authorization until November, when the pharma should have the required safety results.
Guidelines set by the FDA for emergency use authorizations require a median of two months of safety data to assess whether the vaccines are causing any serious side effects.
An advisory committee of independent experts convened by the regulator is discussing those guidelines and other aspects of vaccine development Thursday.