Moderna seeks vax fast track

Moderna said Monday it plans to ask the U.S. Food and Drug Administration to authorize emergency use of its COVID-19 vaccine following new data indicating it’s more than 94% effective.

The Massachusetts-based biotechnology company is the second vaccine developer to request approval, following Pfizer and its partner, the German company BioNTech.

Moderna said it will also ask European regulators for authorization.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” Moderna’s CEO Stephane Bancel said in a statement Monday.

“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death.”

The company’s request for approval comes after an analysis of the third phase of its trial involving 196 participants with coronavirus. In addition to suggesting an effectiveness of 94.1%, the trial indicated the vaccine has an efficacy of 100% against severe cases.

The trial involved 11 participants receiving the Moderna vaccine, and 185 receiving a placebo. Moderna said that when the trial reached a second endpoint, 30 participants were experiencing severe cases of COVID-19 — each of whom were in the placebo group.

One person in the placebo group died of COVID-19, according to Moderna.

Pfizer is set to take part in an FDA hearing on Dec. 10 in which it will share data indicating its vaccine its 95% effective. Moderna then expects to have its vaccine reviewed on Dec. 17.

The latest development comes amid a surge in COVID-19 cases in the U.S. and other parts of the world.

The U.S. reported more than 4 million cases in November alone, more than doubling the previous month.

Since the start of the pandemic, the U.S. has reported more than 13 million confirmed coronavirus cases and more than 266,000 deaths, which are both the most of any country.

“I want to thank the Moderna team and our suppliers and partners for their tireless work on the research, development and manufacturing of our vaccine,” Bancel said.