FDA Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away

By Thomas Tracy and Dave Goldiner, New York Daily News

12 December 20

 

merica will be getting a huge shot in the arm starting on Monday.

Military leaders overseeing the massive effort to distribute hundreds of millions of COVID-19 vaccines vowed to start shipping the Pfizer shots within hours of winning approval.

Gen. Gustave Perna invoked the spirit of World War II, calling Saturday “D-Day” for the effort to end the deadly coronavirus pandemic.

“D-Day was the beginning of the end ... and that’s where we are today,” the leader of Operation Warp Speed told reporters.

The first doses will roll out of a Pfizer facility in Kalamazoo, Mich. on Sunday and will arrive in roughly 150 designated centers on Monday. Another 400 or so centers across the nation will receive their first doses Tuesday.

The massive operation will continue for months as officials deliver vaccines to hundreds of millions of Americans in every corner of the nation.

Gen. Gustave Perna calls beginning of vaccine distribution "D-Day," invoking WWII.

"D-Day, in military, designates 'the day the mission begins.' ... D-Day was the beginning of the end and that's where we are today." https://t.co/1UKoX6EMJp pic.twitter.com/masuDaLGKf

— World News Tonight (@ABCWorldNews) December 12, 2020

Even as the death toll continues to soar towards 300,000 Americans, public health experts say the vaccine from Pfizer and other shots in the pipeline will eventually end the pandemic that has turned life upside down.

The head of the U.S. Food and Drug Administration said earlier Saturday that he plans to take the COVID-19 vaccine that was authorized for emergency use on Friday — and claims he was never pressured to fast track the approval.

“I will absolutely take the COVID-19 vaccine. I have complete confidence in our staff evaluation,” FDA Commissioner Stephen Hahn said in a virtual press conference Saturday with FDA Biologics Director Peter Marks.

Hahn refuted the claim that he was pressured by White House Chief of Staff Mark Meadows into approving the Pfizer vaccine by the end of Friday or risk losing his job.

“The representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate,” he said Saturday. “Science and data guided the FDA’s decision. We worked quickly based on the urgency of this pandemic, not because of any other external pressure.”

The FDA was already planning on granting the vaccine the final OK on Saturday morning, but the alleged strong-arming prompted Hahn to move up the announcement to late Friday, two sources told The Washington Post, which first reported Meadows’ threat.

Hahn said his agency green-lit the the vaccine following a rapid but thorough review that would normally take months, but only took weeks for FDA evaluators who worked long hours and weekends.

“We did not cut corners in this regulatory process. There was a rigorous study in clinical trials,” Hahn said. “Efficiency does not need any cutting of corners.”

“We applied our high standers in reviewing this product so that Americans can trust and have confidence in its safety and effectiveness,” Hahn said. “The federal authorization of this vaccine is a significant milestone in battling the devastating pandemic that has affected so many families in the U.S. and around the world.”

Nursing home residents and health care workers are expected to be first in line for the shot produced by the pharmaceutical giant and a German company, BioNTech.

Tests showed the Pfizer/BioNTech vaccine to be “95% effective against COVID-19 beginning 28 days after the first dose,” Pfizer announced in November. People will need two doses of the vaccine to be inoculated against the disease, scientists say.

Not enough young children and pregnant women were in the study, so the FDA cannot approve use for those groups. Marks recommended pregnant women discuss the matter with their doctors.

Teens older than 16 are allowed to take the vaccine, Marks said.

The FDA will continue to review the vaccine to make sure it remains safe and effective, Hahn said.

Doses of the Pfizer/BioNTech vaccine are expected to be scarce in the coming weeks and months. Several other vaccines are in development, and one from Moderna Inc. could be approved by U.S. authorities in the next week.

One more federal government approval is needed before the Pfizer vaccine is distributed: A Centers for Disease Control panel is expected to OK the Pfizer vaccine on Sunday.