- The world could soon know whether Moderna's experimental coronavirus vaccine prevents people from getting sick, as the pandemic's accelerating spread in the U.S. has resulted in faster-than-expected accrual of COVID-19 cases in the company's large, late-stage clinical trial.
- Under Moderna's plan for the study, which began in late July, an independent monitoring committee would assess the vaccine's effectiveness after 53 cases of COVID-19 had occurred among trial participants. That point has now been passed, the company said Wednesday, and data is now being tabulated for the panel to review.
- The outcome of the committee's analysis, which examines whether the participants who developed COVID-19 had received either Moderna's vaccine or placebo, could be known within days. But results may not be definitively positive or negative — if the vaccine's effectiveness does not surpass or fall below certain prespecified thresholds, the committee would wait for more cases to occur.
Moderna had been expecting the first of two early looks at its trial to come sometime in late November. With COVID-19 cases in the U.S. surging, however, that timeline has been sped up.
Now, the company anticipates that first interim analysis will include "substantially more" than the target 53 cases, which could make it more likely the trial monitoring committee is able to reach definitive conclusions about the vaccine's effectiveness.
Moderna remains "blinded" to results, meaning it does not know whether the cases of COVID-19 observed to date in its trial have involved participants who received the vaccine or placebo. Should the panel recommend the trial continue, that will remain the case. But if the early analysis shows the vaccine to be either strongly effective, or largely ineffective in preventing COVID-19, Moderna would be informed and share the outcome publicly.
Per the trial's statistical rules, the vaccine would need to be at least 74% effective for the study to be declared a success with only 53 cases. If 106 or more cases have occurred, the vaccine would have to surpass 57% efficacy for trial monitors to make that judgment.
The Food and Drug Administration has said coronavirus vaccines must be at least 50% effective in preventing coronavirus infection or disease for the agency to consider an approval.
Expectations for Moderna's shot, which has been a front-running candidate since the pandemic's beginning, are high, particularly after Pfizer and BioNTech this week said their vaccine was more than 90% effective. Both vaccines use the same messenger RNA technology to train the body's immune system against infection by SARS-CoV-2, making it more likely Moderna's shot works as well.
Anthony Fauci, director of the U.S. National Institute for Allergy and Infectious Diseases, on Wednesday told a virtual summit hosted by the Financial Times that he is optimistic Moderna's vaccine will be effective because it's "identical in many respects" to Pfizer and BioNTech's.
NIAID helped develop Moderna's vaccine and is working with the company on its Phase 3 study. Some 30,000 volunteers have enrolled into the trial.
Pfizer and BioNTech's success was a major milestone in scientists' urgent race to find a safe and effective vaccine, giving a glimpse at how the pandemic could eventually be brought under control. But more than one vaccine will be needed to inoculate the world, particularly as supplies of any one shot will be very limited initially and distribution will pose many challenges.
Moderna's could have an edge on Pfizer and BioNTech's in that regard, as it can be kept at warmer temperatures than the minus 94 degrees Fahrenheit (minus 70 degrees Celsius) required for Pfizer and BioNTech's.
Moderna expects to produce 20 million doses of its shot this year, and between 500 million to 1 billion in 2021. The U.S. government, which has contracted with Moderna to buy 100 million doses, has supported testing and manufacturing with nearly $1 billion in funding.
Pfizer has also agreed to provide the U.S. with 100 million doses of it and BioNTech's vaccine, in exchange for almost $2 billion, but hasn't accepted any money for testing and production.