It’s here, it’s on the way, and it’s got FDA approval. Emergency clearance came late tonight, followed by an announcement from the Oval Office from Donald Trump, who welcomed the achievement of his Operation Warp Speed project:
The Food and Drug Administration approved the U.S.’s first COVID-19 vaccine on Friday, a historic moment in a pandemic that killed over 290,000 people in that country and nearly 1.6 million people worldwide.
The FDA’s emergency approval to use the first COVID-19 vaccine is a major milestone in the fight against this devastating pandemic that is affecting so many families in the US and around the world, “said FDA Commissioner Dr. Stephen Hahn in a statement. “Today’s action follows an open and transparent review process that included input from independent science and public health experts and a thorough assessment by the agency’s career scientists to ensure this vaccine meets the FDA’s rigorous scientific standards for safety, efficacy and manufacturing quality that are required to support emergency approval. “
The emergency clearance should trigger the first shipment of 2.9 million doses to 636 locations across the country in 24 hours, particularly hospitals where healthcare workers are expected to be on the front lines. Nursing homes and other long-term care facilities are also given top priority.
Trump made the announcement on Twitter less than an hour ago:
– Donald J. Trump (@realDonaldTrump) December 12, 2020
The New York Times reminds us all of the logistical challenge ahead, but we had months to find out:
The approval sparked an elaborate coordination effort by Pfizer, private shipping companies, state and local health officials, the military, hospitals, and pharmacy chains to get approximately three million doses to health care workers and nursing homes as quickly as possible during the first week Vaccine is kept at ultra-cold temperatures.
Pfizer has signed a contract with the US government to supply 100 million doses of the vaccine by March next. As part of this agreement, the recordings are free to the public.
Each state, along with six major cities, has provided the federal government with a list of locations – mostly hospitals – where the Pfizer vaccine will initially be shipped. 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 are serviced.
McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol wipes, face shields, and other consumables to the same locations where they meet with the vaccines that Pfizer ships in special boxes packed with dry ice to keep them at minus 94 degrees Fahrenheit .
The Pfizer package contains a device that tracks the location of the box, as well as a thermal probe that ensures that the freezer is maintained throughout the journey from the company’s sales offices in Michigan and Wisconsin.
The next questions come from whom – when. For example, my wife is a transplant patient, which puts us in a high risk band. We’re both excited about the vaccination, but we’re not sure we can both make it. We consulted with their transplant center, but they haven’t yet received the data to make the call as to whether she should be taking an mRNA-based vaccine. It shouldn’t be a problem for me, but I may have to wait a while, maybe just as long as the Moderna vaccine is available here in Minnesota, which may be more widely available. We should answer that question in the next few days … hopefully soon. Many families will have questions and concerns based on their individual situation and providers will be overwhelmed the first time they deal with them.
Given everything we all went through in 2020, I am glad to address these logistical issues. We now have a light at the end of the tunnel. Operation Warp Speed delivered – and everyone involved should thank them from a very grateful nation.