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Новости

The FDA has authorized a Covid-19 vaccine. What happens next?

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The US Food and Drug Administration (FDA) on Friday authorized the first Covid-19 vaccine for emergency use in the US, a historic milestone in the battle against a disease that has killed nearly 300,000 Americans and 1.5 million people globally.

But, vaccines don’t save lives, vaccination does. And all involved acknowledge the vaccination campaign about to be undertaken in the US will be among the most logistically challenging public health campaigns in American history, with scant funding for public health departments.

FDA chief assures Americans of Covid vaccine safety after Pfizer authorization

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“We are not taking a victory lap…we know the road ahead of us will be tough,” said Gus Perna, the chief operating officer of the federal government’s Operation Warp Speed vaccine development initiative, on Saturday.

But “make no mistake,” Perna added of the vaccine developed by the US pharmaceutical company Pfizer and German partner BioNTech, “distribution has begun”. So what happens next?

The first shipments arrive Monday

The first vaccine shipments will go from Pfizer manufacturing facilities in Michigan to 145 vaccination sites across the US on Monday, ranging from distribution hubs to hospitals. The US Federal Aviation Administration is already warning airports to get ready for vaccine deliveries, by prioritizing freight planes and ensuring snow is removed.

Delivery will then continue Tuesday and Wednesday, to reach 636 vaccination sites nationally.

A total of 2.9m doses will be in the first shipments

Health workers and long-term care residents will be the first to get these doses, a group including 24 million people. Exactly who is first in line will vary widely depending on where they live.

States have wide latitude to split vaccine allotments as they see fit. As a result, some states have promised most doses to health workers, while others are focusing on nursing homes.

Further, the Pfizer vaccine is a two-dose regimen. The same 2.9 million people vaccinated this week will then need a second “booster” shot three weeks later.

Logistical challenges are complicated by ultra-cold storage needs

Distribution begins a process challenged by the needs of Pfizer’s vaccine itself – including the need to keep the vaccine at -70C (-94F). Doses are being sent to states in specialized, reusable, GPS-tracked shipping containers packed with dry ice.

Each one of those specialized containers has 975 doses in five-dose vials. From the moment the container is sealed, the vaccine inside is good for 10 days. Most states are sending vaccine doses to sites with ultra-cold storage to minimize the amount of vaccine wasted.

Federal authorities want 20 million people vaccinated by 2021

With just a few weeks left in the year, federal authorities hope they can use 40m doses to vaccinate 20 million people before the end of the year. But that would still be significantly short of the 24 million people who are either health workers or long-term care residents.

Another vaccine is in the wings

Next week, federal authorities will consider whether to grant emergency authorization for a second vaccine developed by the US pharmaceutical company Moderna and the National Institute of Allergy and Infectious Diseases federal agency headed by Anthony Fauci.

Operation Warp Speed has pre-ordered 200 million Moderna doses, enough to vaccinate 100 million Americans as it also requires two doses.

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