Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate

Moderna announced it would apply for emergency use authorization from FDA on Monday for its candidate COVID-19 vaccine after data showed the vaccine is more than 94% effective in preventing the disease and was safe. In a press release, the company said that of 196 people in the clinical trial who contracted COVID-19, 185 had received a placebo and only 11 received the active vaccine. Additionally, of the 30 study participants who had severe COVID-19, all were in the placebo group. The effectiveness of the vaccine, known as mRNA-1273, was consistent across all age groups, as well as race and ethnicity, Moderna said. No new safety concerns have been identified. The vaccine caused adverse effects in most recipients, often fever and aches that lasted 1-2 days. The company said it expects FDA’s advisory panel will discuss its candidate vaccine on December 17, a week after it convenes to discuss Pfizer and BioNTech’s candidate vaccine, with authorization expected to come a few days after each meeting.