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: 663511

Reported Deaths: 12633
CountyCasesDeaths
Marion908511647
Lake48510882
Allen35951638
Hamilton32138398
St. Joseph30096513
Elkhart25423417
Vanderburgh21283379
Tippecanoe20096203
Johnson16380360
Porter16009272
Hendricks15855300
Clark11999181
Madison11764319
Vigo11636230
Monroe10363163
Delaware9854179
LaPorte9790197
Howard9075198
Kosciusko8574111
Bartholomew7479147
Warrick7430151
Hancock7418132
Floyd7226170
Wayne6645192
Grant6437157
Boone610389
Morgan6103125
Dubois5923111
Dearborn549068
Cass545899
Marshall5432105
Henry542593
Noble510178
Jackson465167
Shelby461490
Lawrence4189113
Gibson401781
Harrison401064
Clinton396553
Montgomery388483
DeKalb386478
Miami357663
Knox357585
Whitley349837
Huntington346277
Steuben339255
Wabash332376
Putnam331159
Ripley327762
Adams323949
Jasper317043
White297452
Jefferson295474
Daviess285596
Fayette271956
Decatur271088
Greene261680
Posey261431
Wells258575
Scott251250
Clay241544
LaGrange241270
Randolph225576
Spencer218030
Jennings215744
Washington212127
Sullivan203639
Fountain201842
Starke188451
Owen182853
Fulton179337
Jay178328
Carroll176519
Perry173435
Orange171150
Rush165322
Vermillion160842
Franklin159535
Tipton146841
Parke139416
Pike127833
Blackford120727
Pulaski106744
Newton96632
Brown95139
Benton92213
Crawford91013
Martin80214
Warren75814
Switzerland7558
Union67310
Ohio53911
Unassigned0433

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 972605

Reported Deaths: 16750
CountyCasesDeaths
Franklin1123671214
Cuyahoga961861832
Hamilton735721034
Montgomery47359903
Summit40384802
Butler35577505
Lucas35489685
Stark29456803
Warren22464271
Lorain22068414
Mahoning19509537
Lake18445318
Clermont18425201
Delaware16499116
Licking15022189
Fairfield14563180
Trumbull14369413
Greene13595218
Medina13423226
Clark12288248
Wood11575163
Portage11050164
Allen10793216
Richland10316183
Miami10035189
Muskingum8195112
Columbiana8151200
Pickaway8067107
Tuscarawas8054227
Marion7996125
Wayne7886193
Erie6914140
Ross6152128
Geauga6083136
Hancock6006116
Ashtabula5978152
Scioto596280
Lawrence527118
Union513537
Darke5036114
Belmont496659
Huron4825107
Jefferson4806107
Sandusky4780108
Seneca4702107
Washington465791
Athens465047
Mercer458780
Auglaize456180
Shelby441679
Knox4037101
Putnam399390
Madison393553
Fulton380658
Ashland380581
Defiance372583
Brown369844
Crawford358396
Logan355772
Preble353678
Clinton340852
Highland328349
Ottawa324369
Williams302662
Jackson290545
Champaign288149
Guernsey287844
Perry269847
Fayette269141
Morrow260334
Henry246658
Hardin245858
Holmes243293
Coshocton237454
Van Wert229854
Gallia222631
Adams217036
Pike215626
Wyandot210447
Hocking194554
Carroll181341
Paulding160530
Meigs135730
Noble129233
Monroe117027
Morgan101119
Harrison100624
Vinton76613
Unassigned00
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