Pfizer: COVID-19 shot 95% effective, seeking clearance soon

The announcement from Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

Posted: Nov 19, 2020 10:37 AM

NEW YORK (AP) — Pfizer said Wednesday that new test results show its coronavirus vaccine is 95% effective, is safe and also protects older people most at risk of dying — the last data needed to seek emergency use of limited shot supplies as the catastrophic outbreak worsens across the globe.

The announcement from Pfizer and its German partner BioNTech, just a week after they revealed the first promising preliminary results, comes as the team is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

Anticipating that, a Food and Drug Administration advisory panel is on standby to publicly debate the data in early December.

The companies also have begun “rolling submissions” for the vaccine with regulators in Europe, the U.K. and Canada and soon will add this new data.

Pfizer and BioNTech had initially estimated the vaccine was more than 90% effective after counting a group of the earliest infections that occurred in its final-stage testing.

With the new announcement, they have accumulated more infections — 170 — and said only eight of them occurred in volunteers who got the actual vaccine rather than a comparison dummy shot. One of those eight developed severe disease, the companies said.

“This is an extraordinarily strong protection,” Dr. Ugur Sahin, BioNTech’s CEO and co-founder, told The Associated Press.

Even if regulators agree, he dispelled any notion that an end to the pandemic is around the corner, warning “we are now awaiting a hard winter.”

“The available vaccine doses are just too small to ensure that we could make a significant difference to the society” right away, Sahin said. But next year if several companies’ vaccine candidates also work, “we might be able to get control of this pandemic situation late summer 2021.”

The companies have not yet released detailed data on their study, and results have not been analyzed by independent experts. Also still to be determined are important questions such as how long protection lasts and whether people might need boosters — leading experts to caution that people should focus less on the specific numbers and more on the overall promise.

Earlier this week, competitor Moderna Inc. also announced similar effectiveness of its own COVID-19 vaccine candidate, which is made with the same, brand-new technology — using a snippet of the genetic code of the coronavirus to train the body to recognize if the real virus comes along.

For both, “there’s every reason to be enormously optimistic,” said Dr. Paul Offit of Children’s Hospital of Philadelphia, one of FDA’s advisers.

“When these vaccines roll out, you’re only going to know it’s effective for a limited period of time,” he cautioned, adding that more follow-up information will come. “You don’t want to oversell it, but you don’t want to undersell it.”

All eyes are on the progress of potential vaccines as the grim infection toll jumps in the U.S. and abroad as winter weather forces people indoors, in the close quarters that fuels viral spread.

Pfizer and BioNTech said the vaccine was more than 94% effective in adults over age 65, though it is not clear exactly how that was determined with only eight infections in the vaccinated group to analyze and no breakdown provided of those people’s ages.

Sahin said there were enough older adults enrolled in the study and among the placebo recipients who became infected that he is confident “this vaccine appears to work in the higher-risk population.”

While initial supplies will be scarce and rationed, as the supply grows Sahin said the companies have a responsibility to help ensure access for lower income countries as well.

In the U.S., officials expect enough doses of both Pfizer’s and Moderna’s vaccines to vaccinate only about 20 million people at first. The Centers for Disease Control and Prevention will determine who is first in line, expected to include health workers and older adults.

Whatever that prioritization, Gen. Gustave Perna of the Trump administration’s Operation Warp Speed pledged a “fair and equitable” distribution across the U.S. of FDA-authorized doses as they become available. Pfizer would handle shipping of its own doses; the warp speed program will help with support and distributing additional companies’ vaccines if and when they become available.

In addition to the protection findings, Pfizer and BioNTech also said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% of participants.

The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and effectiveness data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 306538

Reported Deaths: 5435
CountyCasesDeaths
Marion41953849
Lake26872453
Allen17621295
Elkhart16905219
St. Joseph16524223
Hamilton12696167
Vanderburgh9552115
Tippecanoe844927
Porter813785
Johnson6231165
Vigo597979
Hendricks5944156
Monroe530349
Clark504077
Madison4858121
Delaware4820103
LaPorte457194
Kosciusko455739
Howard334975
Warrick319572
Floyd311477
Bartholomew308462
Wayne301367
Cass295831
Marshall293744
Grant262949
Noble249846
Hancock246551
Boone240254
Henry240237
Dubois234631
Dearborn215730
Jackson212633
Morgan204443
Gibson181725
Knox181419
Shelby178254
Clinton177821
Lawrence174047
DeKalb172829
Adams166422
Wabash158020
Miami157814
Daviess154643
Fayette147733
Steuben143513
Jasper142111
Harrison141824
LaGrange140129
Montgomery139027
Whitley133412
Ripley128114
Decatur124643
Huntington123510
Putnam123027
Randolph120719
Wells120428
White120321
Clay119822
Posey119616
Jefferson116216
Scott103219
Greene101353
Jay96413
Starke90621
Sullivan88916
Fulton83518
Jennings83214
Spencer8198
Perry81521
Fountain7738
Washington7417
Franklin68626
Carroll67913
Orange66628
Vermillion5993
Owen5987
Parke5606
Newton55312
Tipton55226
Rush5317
Blackford51912
Pike50318
Pulaski37710
Martin3515
Benton3362
Brown3353
Crawford2881
Union2671
Switzerland2555
Warren2382
Ohio2307
Unassigned0266

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 371840

Reported Deaths: 6100
CountyCasesDeaths
Franklin50231667
Cuyahoga36047741
Hamilton29931372
Montgomery20065228
Butler14769146
Lucas14317414
Summit13388316
Stark8792197
Warren819175
Mahoning7276299
Lake682666
Lorain643499
Clermont577248
Delaware556436
Licking549276
Fairfield538464
Trumbull5305147
Greene522364
Clark511464
Allen465485
Marion465251
Wood4491107
Medina447756
Miami425867
Pickaway399348
Columbiana347297
Portage344872
Tuscarawas328658
Wayne318793
Richland316638
Mercer289945
Hancock241337
Ross240759
Muskingum240210
Auglaize231031
Putnam224749
Erie224266
Darke223559
Ashtabula223253
Geauga203351
Scioto195915
Union19118
Shelby190615
Lawrence189438
Athens18864
Seneca180018
Belmont164929
Madison158918
Sandusky154229
Preble152621
Huron152318
Defiance139522
Holmes139139
Logan127816
Knox126318
Fulton124525
Washington121927
Crawford121516
Ottawa121130
Clinton106714
Williams10579
Ashland105222
Highland101317
Jefferson10124
Henry100023
Brown9925
Champaign9475
Jackson93112
Hardin91019
Fayette90317
Van Wert8976
Morrow8882
Guernsey83914
Coshocton82613
Perry78712
Adams78313
Pike7451
Gallia73513
Wyandot71216
Paulding64611
Hocking62616
Noble60223
Carroll45710
Meigs39012
Monroe31821
Morgan2575
Vinton2195
Harrison2023
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