Moderna announced on Monday that it will request emergency use authorization from the Food and Drug Administration for its potential coronavirus vaccine, becoming the second company to do so.
The biotechnology company said in a press release that additional data from phase three trials shows the vaccine, mRNA-1273, is 94.1% effective in preventing COVID-19 and there continue to be no serious safety concerns.
Moderna’s request to the FDA is the second to come during the pandemic, after Pfizer and BioNTech made an emergency use request on Nov. 20. The announcement means the two-dose vaccination could be available to Americans in a few weeks.
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The company announced earlier this month that preliminary results based on 95 coronavirus cases showed the vaccine was 94.5% effective. The new results are based on 196 cases, of which 30 were severe.
Of the 196 cases, 185 were among people in the study’s placebo group, versus 11 among people who had received the vaccine. Additionally, all of the 30 severe cases of COVID-19 were among people who had not received Moderna’s vaccine.
One coronavirus-related death has occurred in the study to date, taking olace in the placebo group, Moderna said.
Researchers have not seen major side effects, with the most common adverse reactions being infection site pain or redness, fatigue, headache and muscle aches.
Moderna said in the release that the FDA’s Vaccines and Related Biological Products Advisory Committee will likely schedule a meeting to review the vaccine’s safety and efficacy data for Dec. 17.