Moderna follows Pfizer, seeks vaccine approval
Doctor considers results to be ‘a game-changer’
Biotech company Moderna was to apply Monday for an emergency use authorization from the U.S. Food and Drug Administration after receiving more good news about the effectiveness of its candidate COVID-19 vaccine.
Moderna is the second vaccine maker to request authorization from the federal government after similarly positive results for Pfizer and its German collaborator Biontech’s candidate vaccine.
Moderna said its latest findings showed that of 196 people in the clinical trial who caught COVID-19, 185 had received the placebo, while only 11 received the active vaccine. That’s an effectiveness rate above 94%.
Of the 30 participants who suffered severe disease, all were in the placebo group, which suggests the vaccine prevents mild and serious disease. One placebo recipient died.
Effectiveness was consistent across age groups, race and ethnicity. The 196 participants with cases of COVID-19 included 33 adults over 65 and 42 who identified as Hispanic, Black, Asian American or multiracial.
The Moderna vaccine, called MRNA-1273, also has been shown to be safe, with no new safety concerns identified. It caused side effects in the majority of recipients, usually fever and aches lasting a day or two.
Moderna said it expects the FDA’S advisory committee to discuss MRNA-1273 Dec. 17, a week after it meets to discuss Pfizer’s vaccine. Authorization is expected a few days after each meeting.
“These results are stunning,” said Dr. Robert Wachter, chairman of the department of medicine at the University of California-san Francisco, adding that he is particularly impressed by the vaccine’s success in preventing serious disease. “This is a remarkably effective vaccine and, with results like that, a game-changer.”
Moncef Slaoui, who co-leads the government’s Operation Warp Speed, which has overseen the development of Moderna’s vaccine and helped finance production of Pfizer’s, also is impressed with the novel MRNA technology.
“I think the Moderna data continue to support how exceptionally effective MRNA vaccines are,” he said. He also touted the effectiveness against severe disease “and also 87% protection in subjects above the age of 65, the most impacted group in our population.”
Dr. Peter Hotez, a pediatrician and co-director of the Texas Children’s Hospital Center for Vaccine Development, called the news “really impressive, with the caveat that it’s a company press release.”
Hotez said the vaccine provided so much protection it may be unethical to continue allowing participants in other clinical trials to receive a placebo.
Dr. Stephen Hoge, Moderna president, emphasized the success of his company’s vaccine and how quickly scientists were able to develop it.
“Everything on this has gone faster than expected,” he said. “The data is truly exciting.”