On Tuesday, Moderna announced that it will apply for FDA authorization of its COVID-19 vaccine today, after the final analysis of its clinical trial data confirmed that it is safe and 94 percent effective.
In a press release, Moderna said that there were 196 cases of symptomatic COVID-19 reported in the 30,000-person trial. Of those cases, 185 developed in people who received a placebo, and 11 cases developed in people who took the vaccine. There were 30 cases of severe disease in the trial, and all of them were in the placebo group — indicating that the vaccine can prevent the most dangerous forms of COVID-19.
Stéphane Bancel, Moderna’s chief executive officer, told The New York Times that the FDA’s vaccine advisory committee would review the application on December 17th. If it’s authorized as expected, he said the first people could get their first shots on December 21st.
However, Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, cautioned that there could be a longer lag between the advisory committee meetings and authorization of the vaccines.
He said: “It’s possible that it could be within days, but our goal is to make sure it is certainly within a few weeks.”
Moderna said it could have up to 20 million doses of the vaccine, enough to vaccinate 10 million people, by the end of 2020.
If authorized, more doses of these vaccines will be available through January and February, and other people in high-risk groups — like those with underlying medical conditions and adults over the age of 65 — should start to get access to vaccines.
