Breaking: FDA approves Pfizer COVID-19 vaccine; 1st US vaccination within 24 hours, says Trump

It’s here, it’s on its way, and it has FDA approval. The emergency-use authorization came late tonight, followed immediately by an Oval Office announcement from Donald Trump, who hailed the achievement of his Operation Warp Speed project:

The Food and Drug Administration on Friday authorized the United States’ first COVID-19 vaccine, a historic moment in a pandemic that has killed over 290,000 in this nation and nearly 1.6 million people worldwide.

The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Dr. Stephen Hahn, said in a statement. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”

The emergency use authorization was expected to trigger the first shipment of 2.9 million doses to 636 sites across the country within 24 hours, primarily to hospitals where front-line health care workers are expected to receive them. Nursing homes and other long-term care facilities are also considered a top priority.

Trump made the announcement on Twitter less than an hour ago:

The New York Times reminds us all of the logistical challenge to come, but we’ve had months to game this out:

The authorization set off a complicated coordination effort from Pfizer, private shipping companies, state and local health officials, the military, hospitals and pharmacy chains to get the first week’s batch of about three million doses to health care workers and nursing home residents as quickly as possible, all while keeping the vaccine at ultracold temperatures.

Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public.

Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies.

McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol pads, face shields and other supplies to the same sites, where they will meet up with the vaccines that Pfizer is shipping in special boxes, packed with dry ice, designed to keep them at minus 94 degrees Fahrenheit.

The Pfizer packaging will include a device that tracks the location of the box, plus a thermal probe that will make sure the deep freeze is maintained throughout the journey from the company’s distribution sites in Michigan and Wisconsin.

The next questions will come from who can take it — and when. For instance, my wife is a transplant patient, which puts us into a high-risk band. Both of us are enthusiastic about getting vaccinated, but we’re not sure we can both take it. We have been consulting with her transplant center, but they have not yet received the data to make the call as to whether she should take an mRNA-based vaccine. It should be no problem with me, but I might need to wait for a while, perhaps only as long as it takes to get the Moderna vaccine out here in Minnesota, which might be in larger supply. The next few days should get us answer to those question … hopefully soon. Many families will have questions and concerns based on their individual situations, and providers will be overwhelmed at first dealing with them.

Given everything we’ve all been through in 2020, I’m happy to be dealing with those logistical issues. We now have a light at the end of the tunnel. Operation Warp Speed delivered — and everyone involved should get thanks from a very grateful nation.

View Original Source Source