US FDA did authorize the Pfizer vaccine on an emergency basis for age 16 and older
Tonight from The New York Times;In response to:
BREAKING NEWS
The F.D.A. authorized Pfizer’s coronavirus vaccine for emergency use, allowing millions of highly vulnerable people to begin receiving it within days.
Friday, December 11, 2020 9:13 PM EST
The U.S. is the sixth nation to authorize the vaccine. Federal officials have said about 2.9 million doses will be sent in the first week.
Health care workers and nursing home residents are expected to be inoculated first.
F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away
An initial shipment of about 2.9 million doses of the vaccine will be sent around the United States over the next week.
By Katie Thomas, Sharon LaFraniere, Noah Weiland, Abby Goodnough and Maggie Haberman
Dec. 11, 2020
The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.
The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.
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 decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95 percent effective.
An expert panel advising the F.D.A. on Thursday gave its approval of Pfizer’s vaccine for people 16 and older, and the agency was planning to release the formal authorization on Saturday. That timeline was accelerated by half a day after President Trump attacked Dr. Hahn for failing to authorize a vaccine more quickly. But the accelerated announcement was not expected to speed up the delivery of vaccines around the country.
BREAKING NEWS
The F.D.A. authorized Pfizer’s coronavirus vaccine for emergency use, allowing millions of highly vulnerable people to begin receiving it within days.
Friday, December 11, 2020 9:13 PM EST
The U.S. is the sixth nation to authorize the vaccine. Federal officials have said about 2.9 million doses will be sent in the first week.
Health care workers and nursing home residents are expected to be inoculated first.
F.D.A. Clears Pfizer Vaccine, and Millions of Doses Will Be Shipped Right Away
An initial shipment of about 2.9 million doses of the vaccine will be sent around the United States over the next week.
By Katie Thomas, Sharon LaFraniere, Noah Weiland, Abby Goodnough and Maggie Haberman
Dec. 11, 2020
The Food and Drug Administration authorized Pfizer’s Covid-19 vaccine for emergency use on Friday, clearing the way for millions of highly vulnerable people to begin receiving the vaccine within days.
The authorization is a historic turning point in a pandemic that has taken more than 290,000 lives in the United States. With the decision, the United States becomes the sixth country — in addition to Britain, Bahrain, Canada, Saudi Arabia and Mexico — to clear the vaccine. Other authorizations, including by the European Union, are expected within weeks.
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 decision is a victory for Pfizer and its German partner BioNTech, which began working on the vaccine 11 months ago. Vaccines typically take years to develop. The companies’ late-stage clinical trial, which enrolled nearly 44,000 people, was found to be 95 percent effective.
An expert panel advising the F.D.A. on Thursday gave its approval of Pfizer’s vaccine for people 16 and older, and the agency was planning to release the formal authorization on Saturday. That timeline was accelerated by half a day after President Trump attacked Dr. Hahn for failing to authorize a vaccine more quickly. But the accelerated announcement was not expected to speed up the delivery of vaccines around the country.