Here’s what we know about the Moderna vaccine results!

The Modern vaccine trial, called the COVE Phase 3 trial, completed enrollment of more than 30,000 people in late october. On Monday, they released the first set of results.

Primary outcome: symptomatic COVID

Results from an interim analysis by the data safety monitoring board (DSMB) show the new vaccine is 94.5% effective at preventing symptomatic, confirmed cases of COVID-19. This is much better than the required 50% efficacy needed for federal approval.

Secondary outcome: severe COVID

The secondary outcome is whether the vaccine can prevent severe cases of COVID-19. Severe COIVD-19 is defined in several ways including:

  • Respiratory failure or Acute Respiratory Distress Syndrome OR
  • Acute kidney, liver, or neurologic dysfunction, OR
  • Admission to an intensive care unit OR
  • Death

So far in the Moderna trial, there were 11 cases of severe COVID, and they all occurred in the placebo group. There were no cases of severe COVID in the vaccinated group.

What about safety and side effects, you ask?

Side effects were more common after the second dose and so far have included:  Fatigue (9.7%), Muscle pain (8.9%),  Joint pain (5.2%), Headache (4.5%), Pain (4.1%) or redness (2.0%) at the injection site.

Next steps

Scientists would still like to see all the data published in a scientific journal. But Moderna has already provided a lot of data in its press release. And the results were reviewed by an independent data safety monitoring board (DSMB). The DSBM isn’t involved in the study. In this case, the DSMB was appointed by the National Institutes of Health (NIH). It’s one of the many mechanisms that ensures rigor, quality, and transparency in every clinical trial.

Another good sign is that the Modernal interim results are similar to the Pfizer results. Since they are both the same type of vaccine, and the results are similar, we feel more confident in the results. So though all this is good news, we’re still months away from an approved vaccine and longer still until it’s widely available. 

 

Last update: November 17, 2020, 4:20 pm ET

Science review: JAB