Moderna will file for emergency use authorization of its COVID-19 vaccine candidate with the FDA Nov. 30.
The vaccine was 94.1 percent effective against COVID-19 in a phase 3 clinical trial and 100 percent effective against severe cases of COVID-19. The trial included 30,000 participants, and 196 contracted COVID-19, 30 of whom had severe cases. The vaccine's efficacy was consistent across age, race and ethnicity and gender demographics, Moderna said.
No serious safety concerns were reported, and Moderna will also apply Nov. 30 for a conditional marketing authorization with the European Medicines Agency. The most common side effects of the vaccine were injection site pain, fatigue, headache, muscle and joint pain and redness at the injection site. Side effects were more common and more severe after the second dose of the vaccine, Moderna reported.
"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," Moderna CEO Stéphane Bancel said in a news release.
The drugmaker said the FDA's advisory committee on vaccines will likely meet Dec. 17 to assess the vaccine's safety and efficacy data. The company expects to have 20 million doses of its vaccine available this year and 500 million to 1 billion doses ready in 2021.
Read Moderna's full news release here.