President Donald Trump confirmed Friday that the Food and Drug Administration (FDA) has authorized a second coronavirus vaccine for emergency use.
“Congratulations, the Moderna vaccine is now available!” the president tweeted Friday evening.
Moderna gets the green light
The FDA released a statement Friday indicating that it had granted an emergency use authorization request that was submitted by Moderna on Nov. 30.
The decision was expected, as an advisory committee to the FDA had overwhelmingly recommended the Moderna vaccine a day earlier, Breitbart noted.
“Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDA’s expectations described in our June and October guidance documents have been met,” Dr. Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, said of the move.
Like the Pfizer vaccine that started being distributed this week, Moderna’s is a two-dose vaccine; patients will receive a second vaccination about a month after the first one, the FDA said in its statement.
According to the FDA, the Moderna vaccine teaches the body to “react defensively” to the SARS-CoV-2 virus that causes the novel coronavirus disease known as COVID-19.
Thus far, the Moderna vaccine has only been authorized for patients 18 years of age or older, the FDA noted.
Common side effects reported by the agency include “pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea, and vomiting, and fever.” The side effects are said to be more common after the second dose and typically last for “several days.”
Big wins for Trump, America
The FDA’s authorization of Moderna’s vaccine marks the second big win this week for President Trump and his administration’s Operation Warp Speed. The initiative has resulted in the production of two vaccines faster than experts predicted that America would get one — and according to FDA Commissioner Stephen Hahn, no corners were cut.
“Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA,” Hahn said in a statement.