FDA finds Moderna coronavirus vaccine is effective and safe

The Food and Drug Administration released data showing that Moderna's COVID-19 vaccine is safe and effective.

The FDA's review, which was published on Tuesday, confirmed Moderna’s previous assessment that its vaccine had an efficacy rate of 94.1% in a trial of 30,000 people. It noted that potential side effects of the vaccine include fever, headache, and fatigue but added that those unintended effects were not dangerous.

The vaccine's high efficacy was documented after two doses of the vaccine were administered 28 days apart.

The data release is another step for Moderna’s vaccine to get emergency use authorization from the Food and Drug Administration, which is set to happen before the end of the week, senior administration officials said Monday. Similar to Thursday's daylong review process of the Pfizer vaccine ending with a vote in favor of authorization, the Moderna vaccine will be reviewed by the FDA’s panel of immunologists, epidemiologists, and public health experts Thursday.

The Pfizer and BioNTech COVID-19 vaccine has been distributed, and medical first-responders began getting vaccinated on Monday.

The United States has reported more than 16 million cases of COVID-19 since the pandemic began, according to data from Johns Hopkins University, and the country surpassed 300,000 coronavirus-related deaths on Monday. The U.S., like many countries, is in the middle of the worst surge in cases yet, with fears that holiday travel from Thanksgiving and winter festivities will only compound an already worsening situation.