Moderna CEO Expects COVID-19 Vaccine Interim Results in November

Moderna CEO Stéphane Bancel said the U.S. government could authorize emergency use of his firm's experimental COVID-19 vaccine in December, if a large clinical trial yields positive interim results in November, reports the Wall Street Journal . Moderna in July initiated a 30,000-person U.S. study to assess the vaccine's protective effects from symptomatic COVID-19, and the trial's enrollment is nearly done. Half of the study subjects will receive the vaccine and half will receive a placebo, and the first interim analysis of the vaccine's efficacy will happen when 53 participants get symptomatic COVID-19. If there are significantly fewer vaccinated people than unvaccinated people among those cases, then Moderna may deem the outcome adequate to solicit government authorization of wider use. Bancel noted that while the first analysis is likely to occur next month, "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick." Moderna also must watch the safety of at least half of study subjects for two months following vaccination before it can pursue emergency use authorization. Bancel said that threshold was likely to be reached in late November, and should Moderna file for an emergency use authorization soon after, the Food and Drug Administration may take several weeks to vet the application before deciding in December. Failure to demonstrate sufficient efficacy at the first interim analysis will prompt Moderna to perform a second analysis when 106 symptomatic COVID-19 cases occur — probably in December.