U.S. FDA approves Pfizer COVID-19 vaccine for emergency use, according to a letter issued by FDA Chief Scientist Denise Hinton.
FDA (Food and Drug Administration) has authorized Pfizer and BioNTech’s Covid-19 vaccine for emergency use.
In a letter, Hinton said she was authorizing the emergency use of the Pfizer-BioNTech vaccine.
President Donald Trump described it as a “medical miracle” in a video tweet. “We’ve delivered a safe and effective vaccine in just 9 months,” Trump said. “This is one of the greatest scientific accomplishments in history.”
According to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, the announcement “holds the promise to alter the course of this pandemic in the United States.”
“With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” he said.
With the FDA’s emergency use authorization, the federal government can now distribute doses of the Covid-19 vaccine to 64 states, territories, and major cities across the country. The government will ship 2.9 million doses of the vaccine within 24 hours, followed by an additional 2.9 million doses 21 days later for the second shot, Gen. Gustave Perna, who oversees logistics of the Operation Warp Speed, said Wednesday. People have to take two doses of Pfizer’s vaccine, administered three weeks apart.
The authorization from FDA comes as hospitals across the U.S. suffer a higher load of coronavirus patients than ever before, and the country’s outbreak is at record high. The U.S. now has 3,124 new Covid-19 deaths on Wednesday, according to a CNBC analysis of Johns Hopkins University data.
Meanwhile, FDA Commissioner Stephen Hahn said they were “rapidly” working toward having the vaccine authorized for emergency use. Shortly after Hahn’s statement, Trump told the agency in a tweet to “Get the dam vaccines out NOW.”
FedEx and United Parcel Service have expressed their confidence in distributing the vaccines around the country with plans to track shipments’ location and temperatures all set.
The Federal Aviation Administration late Friday called on airports to ensure they have enough workers as vaccines arrive.
Pfizer said that final analysis revealed that its coronavirus vaccine does not only have an efficacy of 95% even in adults, but it also caused no serious safety concerns. The new report validates the company’s earlier claim of a greater than 90% efficacy.
If FDA approves Pfizer, the vaccines that are coming from its Michigan manufacturing facility in December and the first quarter of 2021 will be distributed in the country, Dr. Scott Gottlieb said on “Squawk Box.” Under the deal announced in July, the U.S. government could buy 500 million Pfizer Covid vaccine doses more.
“Pfizer did offer up an additional allotment coming out of that plant, basically the second-quarter allotment, to the United States government multiple times and as recently as after the interim data came out and we knew this vaccine looked to be effective,” said Dr. Gottlieb, who previously headed the FDA in the Trump administration from 2017 to 2019.