UPDATED 1:55 PM PT – Saturday, December 19, 2020
The FDA officially authorized Moderna’s coronavirus vaccine for emergency use.
On Friday, the agency gave the green light, making this the second COVID-19 vaccine to be approved in the U.S. President Trump took to Twitter soon after to congratulate the American biotech company.
Congratulations, the Moderna vaccine is now available!
— Donald J. Trump (@realDonaldTrump) December 19, 2020
The announcement came after a panel of FDA advisers ruled, in a 20-to-0 vote, that the benefits of the vaccine outweighed the risks for those 18-years-old and up.
“The transparency around our review of the Moderna COVID-19 vaccine should assure the public that this vaccine met the FDA’s rigorous standards for quality, safety and efficacy,” FDA Commissioner Stephen Hahn stated. “As with any decision made by the FDA, this authorization was guided solely by science and data. ”
The commissioner said he is proud of his team. He also added that scientists worked quickly based on the urgency of the pandemic, not because of any external pressure.
Earlier this week, the FDA approved a coronavirus vaccine by Pfizer and its german partner, BioNtech. Moderna’s shot shows a similar level of effectiveness by providing 94 percent protection against the virus with fewer side effects.
According to the director of the FDA’s Center for Biologics Evaluation and Research, the agency is investigating at least five allergic reactions in people who were given the Pfizer vaccine.
“It is known that one of the components that are present in both of the vaccines, polyethylene glycol, can be associated uncommonly with allergic reactions,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “But what we’re learning now is perhaps those allergic reactions could be somewhat more common than the highly uncommon that we thought… because people do get exposed to polyethylene glycol in various pharmaceutical preparations.”
Marks added the agency will be monitoring the rollouts closely.
On Saturday, U.S. Army General Gustave Perna said the vaccine is expected to arrive at nearly 4,000 locations by Sunday. He added healthcare providers could expect to receive the Moderna vaccine by Monday.