Major New Vaccine Seeks Emergency FDA Approval as Skepticism Flourishes

We are now several months into the COVID-19 pandemic, and no amount of social distancing or mask wearing has yet saved us from this highly contagious scourge.

The pandemic has been especially troubling in the United States, where jaded and annoyed citizens are letting their guards down around the holidays.  Some medical experts have suggested that Thanksgiving itself may have been a “super spreader” event, which, if true, certainly doesn’t bode well for our Christmas plans.

But there is another weapon on the way in the COVID war, should the FDA get around to allowing us to have it.

Moderna announced Monday it will ask the Food and Drug Administration for emergency use authorization (EUA) for its COVID-19 vaccine, making it the second company, after Pfizer, to seek EUA for a COVID-19 vaccine in the United States.

Pfizer’s public FDA hearing — a crucial step in the authorization process — is scheduled for Dec. 10, and the FDA could make its official authorization decision shortly thereafter.

In an early morning press release, Moderna announced that its FDA hearing will be held a week later, on Dec. 17. Moderna also announced its coronavirus vaccine is more than 94% effective, according to the final analysis of its massive Phase 3 trial.

Among the more than 30,000 volunteers in Moderna’s Phase 3 trial, 196 ultimately developed COVID-19, but the vast majority of those COVID-19 cases happened among volunteers who had been given a placebo injection — an imbalance hefty enough for biostatisticians to feel confident the vaccine is highly effective.

The hard part may actually be getting people to take the vaccine, however.

The number of Americans willing to get a COVID vaccine is on the rise, but still remains less than 60% of those surveyed.  In order for America to reach a vaccine-assisted “herd immunity”, 70% or more of the population will need to be vaccinated.