The feds could clear Moderna’s experimental coronavirus vaccine for emergency use in December if the company’s clinical research goes according to plan, CEO Stéphane Bancel reportedly said.
That timeline depends on the Massachusetts-based biotech firm getting positive results next month from its late-stage clinical trial of the vaccine, Bancel said during a Wall Street Journal conference on Monday.
Moderna will analyze how well the vaccine is working when 53 people in its Phase 3 study develop symptomatic cases of COVID-19, the Journal reported. That analysis is expected to take place in November, though the exact timing is tough to predict “because it depends on the cases, the number of people getting sick,” Bancel said.
The company also expects to have enough data on the vaccine’s safety in late November, Bancel said. The US Food and Drug Administration could decide whether to gr ant an emergency use authorization for the shot in December if Moderna submits an application soon after reaching that safety milestone, according to the Journal.
However, it’s possible that the vaccine won’t be deemed effective enough when the initial data is analyzed next month, the paper reported. Moderna would then reportedly conduct a second analysis when 106 people get sick with the coronavirus.
But Bancel said that likely wouldn’t happen until December, meaning the FDA couldn’t grant emergency approval until late January or early February.
Moderna’s targeted timeline is similar to Pfizer’s. The Manhattan-based drugmaker — which is developing a vaccine with the German firm BioNTech — said last week that it could seek emergency approval for its COVID-19 shot as soon as late November.
AstraZeneca and Johnson & Johnson have also started Phase 3 clinical trials for their respective coronavirus vaccines, but both companies have had to pause their studies after participants got sick.
Moderna shares jumped 3.6 percent in premarket trading Tuesday to $73.54 as of 7:18 a.m. after the Journal reported Bancel’s comments. The FDA did not immediately respond to a request for comment on his remarks.