Moderna to apply for emergency use authorization for COVID-19 vaccine candidate
Moderna announced that it will apply for emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate on Monday.
The company said in a statement that testing showed its vaccine candidate was 94.1 percent effective in preventing COVID-19 and was 100 percent effective against severe COVID-19.
It also said “no serious safety concerns” have been identified to date. Some trial participants have experienced reactions like pain at the site of the injection or fatigue.
What’s next: The FDA’s Vaccines and Related Biological Products Advisory Committee is likely to meet on Dec. 17 to review the Moderna vaccine candidate’s safety and efficacy data, according to the company. The drugmaker expects to have made about 20 million doses of the virus available in the U.S. by the end of the year.
Pfizer, meanwhile, has announced its own candidate is 95 percent effective, following interim data showing it was 90 percent effective against the virus.
The extremely high efficacy of two different vaccines is welcome news in the fight against the pandemic, but there are still several tough months before it will be available on a broad scale.