CLOSINGS: View Closings

Pfizer seeking emergency use of its COVID-19 vaccine in US

Pfizer is set to ask U.S. regulators to allow emergency use of its COVID-19 vaccine, starting a process that could bring first shots as early as next month.

Posted: Nov 20, 2020 6:48 AM

Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter.

The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday's FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.

With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.

“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer's announcement, adding that it's too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we're waiting for that help to come.”

Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. Globally, Pfizer has estimated it could have 50 million doses available by year's end.

About 25 million may become available for U.S. use in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart.

Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.

Here’s what happens next:

MAKING THE DATA PUBLIC

The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.

So far, what's known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who'd received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cites results from 38,000 study participants who've been tracked for two months after their second dose. That's a milestone FDA set because historically, vaccine side effects don't crop up later than that.

“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.

Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.

They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?

There’s still no guarantee. “We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.

EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL

If there's an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.

There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?

That’s why the 44,000-person study needs to keep running -- something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.

And at least for now, pregnant women won't qualify because they weren't studied. Pfizer only recently began testing the vaccine in children as young as 12.

A decision on Pfizer's vaccine won't affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.

MANUFACTURING

Brewing vaccine is more complex than typical drug manufacturing, yet the millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must be the same purity and potency as every dose before and after.

That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.

The Pfizer-BioNTech vaccine -- and Moderna's shots -- are made with brand-new technology. They don’t contain the actual coronavirus. Instead, they’re made with a piece of genetic code for the “spike” protein that studs the virus.

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

GETTING INTO PEOPLE’S ARMS

Another government group -- advisers to the Centers for Disease Control and Prevention -- decides who is first in line for scarce doses. Health and Human Services Secretary Alex Azar said he hopes that decision can be made at the same time as FDA’s.

The Trump administration’s Operation Warp Speed has worked with states to line up how many doses they’d need to cover the populations offered vaccine first.

Pfizer will ship those supplies as ordered by the states -- only after FDA gives the OK.

Company projections of how much it will ship each month are just predictions, Baylor warned.

“It’s not like a pizza,” he said. Manufacturing is so complex that “you don’t necessarily end up with what you thought.”

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 333626

Reported Deaths: 3843
CountyCasesDeaths
Hennepin700691145
Ramsey29459521
Dakota23564198
Anoka23541236
Washington14864125
Stearns14564125
St. Louis9549121
Scott896460
Wright847548
Olmsted714637
Sherburne618746
Clay529960
Carver509715
Kandiyohi440828
Rice432338
Blue Earth431217
Crow Wing383339
Otter Tail338925
Chisago334516
Benton322753
Nobles316032
Winona297832
Douglas283040
Mower274823
Polk271527
Morrison246731
McLeod233721
Lyon232812
Beltrami230718
Goodhue222932
Becker221521
Steele21038
Itasca206324
Isanti203917
Carlton201417
Todd190314
Nicollet172126
Mille Lacs164632
Freeborn16227
Le Sueur157012
Brown156115
Cass153511
Pine14498
Meeker144812
Waseca143411
Roseau13035
Martin124721
Hubbard119729
Wabasha11301
Redwood104620
Chippewa9808
Renville95530
Cottonwood9454
Dodge9311
Watonwan8944
Wadena8637
Sibley8404
Rock8249
Houston8004
Aitkin79930
Fillmore7690
Pipestone76518
Pennington7058
Yellow Medicine69612
Kanabec68614
Swift63610
Murray6124
Faribault6093
Pope5721
Clearwater55410
Marshall5459
Stevens5403
Jackson5321
Lake4518
Koochiching4216
Wilkin4175
Lac qui Parle4124
Lincoln3811
Unassigned38159
Norman3718
Big Stone3392
Mahnomen3225
Grant2986
Kittson2518
Red Lake2303
Traverse1531
Lake of the Woods1071
Cook800

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 237371

Reported Deaths: 2571
CountyCasesDeaths
Polk34873347
Linn14787169
Scott1184692
Black Hawk11288147
Woodbury10763137
Johnson985939
Dubuque947999
Story701924
Pottawattamie682474
Dallas661260
Sioux383829
Webster378339
Cerro Gordo373252
Marshall360950
Clinton345645
Buena Vista316614
Muscatine305172
Des Moines300623
Warren294115
Plymouth287044
Wapello265072
Jones237118
Jasper231546
Lee228719
Marion211922
Carroll204325
Bremer202713
Henry19367
Crawford183116
Benton175423
Tama157442
Jackson151117
Washington150216
Delaware147621
Dickinson145812
Boone144912
Mahaska133928
Wright13107
Clay12505
Buchanan123410
Hardin122812
Hamilton119514
Page11925
Kossuth11768
Clayton115510
Cedar114614
Harrison113432
Floyd111921
Mills11129
Calhoun10987
Fayette109812
Lyon10769
Butler10748
Winneshiek105513
Poweshiek103714
Iowa101414
Cherokee9674
Winnebago96325
Chickasaw9195
Hancock9138
Sac9068
Louisa90122
Grundy89514
Allamakee88413
Cass84725
Union8437
Mitchell8429
Appanoose81613
Humboldt8125
Shelby80511
Emmet79026
Guthrie78315
Franklin76421
Jefferson7635
Madison7265
Unassigned7090
Palo Alto6744
Keokuk6567
Pocahontas6024
Howard5859
Ida54915
Osceola5461
Greene5422
Montgomery51411
Clarke5064
Davis4839
Taylor4833
Monona4567
Adair4539
Monroe45113
Worth3881
Fremont3823
Van Buren3815
Decatur3410
Lucas3416
Audubon3112
Wayne3087
Ringgold2432
Adams1812
Rochester
Clear
29° wxIcon
Hi: 43° Lo: 20°
Feels Like: 23°
Mason City
Clear
23° wxIcon
Hi: 45° Lo: 21°
Feels Like: 23°
Albert Lea
Clear
25° wxIcon
Hi: 45° Lo: 23°
Feels Like: 25°
Austin
Clear
27° wxIcon
Hi: 45° Lo: 22°
Feels Like: 27°
Charles City
Clear
28° wxIcon
Hi: 46° Lo: 21°
Feels Like: 20°
A Quiet Weekend Ahead
KIMT Radar
KIMT Eye in the sky

Community Events