Pfizer and BioNTech say final analysis shows coronavirus vaccine is 95% effective with no safety concerns

Pharmaceutical company Pfizer revealed a 95% effectiveness rate for their coronavirus vaccine and will be submitting for FDA authorization within days. CNN's Sanjay Gupta reports.

Posted: Nov 18, 2020 11:36 AM


A final analysis of the Phase 3 trial of Pfizer's coronavirus vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, the company said Wednesday.

The company counted 170 cases of coronavirus infection among volunteers who took part in the trial. It said 162 infections were in people who got placebo, or plain saline shots, while eight cases were in participants who got the actual vaccine. That works out to an efficacy of 95%, Pfizer said.

The data show Pfizer's initial claim of a better than 90% efficacy -- a claim that stunned and pleased health officials and vaccine developers last week -- holds up.

"Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%," Pfizer and its German partner BioNTech said in a joint statement.

"There were 10 severe cases of Covid-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group." BNT162b2 is the experimental name for the vaccine.

An independent group has been keeping an eye on results and side-effects. "To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine," the companies said.

"The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2," the companies said. Older adults tended to have fewer adverse events and those they had were milder.

Pfizer will seek EUA 'within days'

Pfizer said it will seek US Food and Drug Administration emergency use authorization "within days."

"These data also will be submitted to other regulatory agencies around the world," Pfizer said. They plan to publish the data in a peer-reviewed scientific journal, as well.

"The rapid protection this vaccine provides -- combined with its tolerability profile in all age groups studied so far -- should help make this vaccine an important tool to address the current pandemic," said Dr. Ugur Sahin, CEO and co-founder of BioNTech.

Pfizer said on November 9 that interim data provided initial evidence the vaccine had an efficacy of more than 90%. That data was based on the first 94 cases of coronavirus infection among volunteers. The company said at the time it would need to count more cases of infection in the trial before it could consider the Phase 3 part of the trial finished and seek FDA authorization.

The Phase 3 clinical trial of the vaccine began on July 27. Pfizer said of 43,661 volunteers enrolled, 41,135 have received a second dose of the vaccine or placebo. The FDA said it wanted at least two months of safety tracking on volunteers after they got their second shots.

The companies also said they have tried to recruit a diverse pool of volunteers, to match more closely the groups most severely affected by the pandemic. "Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age," Pfizer said.

The 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina will continue to collect information about efficacy and safety for two more years.

1.3 billion doses expected in 2021

"Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021," they said.

Pfizer has three US vaccine manufacturing sites in St. Louis, Kalamazoo, Michigan and Andover, Massachusetts, plus one in the Belgian city of Puurs. "BioNTech's German sites will also be leveraged for global supply," the companies said.

Many states have expressed concern about the fragility of the Pfizer vaccine, which must be kept at minus 75 degrees Celsius, or minus 103 degrees Fahrenheit -- far below the capability of standard freezers.

But the companies said their custom packaging would help.

"Pfizer is confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world," they said.

"The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C," they added.

"They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer's broad distribution network."

Vaccine maker Moderna released interim efficacy data Monday showing its vaccine provided about 95% protection.

Both Moderna's and Pfizer's vaccine use a new and relatively untested vaccine technology that employs genetic material called messenger RNA or mRNA. The mRNA encodes for a piece of the coronavirus's spike protein-- the structure it uses to attach to cells it attacks.

When injected into people, it causes some cells to produce little pieces of this spike protein, which the immune system recognizes and develops antibodies and immune cells to attack. So when a vaccinated person is exposed to the real virus, the immune system is already primed to neutralize it quickly.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 313166

Reported Deaths: 7228
CountyCasesDeaths
DeSoto21496257
Hinds20294414
Harrison17814309
Rankin13573278
Jackson13411246
Madison10066217
Lee9962173
Jones8364163
Forrest7649152
Lauderdale7181240
Lowndes6370145
Lamar621686
Lafayette6171118
Washington5323133
Bolivar4797132
Oktibbeha461498
Panola4561105
Pearl River4499145
Marshall4397103
Warren4380121
Pontotoc419572
Monroe4100133
Union409076
Neshoba4026176
Lincoln3950110
Hancock377786
Leflore3487125
Sunflower335790
Tate332484
Pike3301105
Scott315373
Alcorn311968
Yazoo310769
Itawamba299477
Copiah296465
Simpson294788
Coahoma294379
Tippah287768
Prentiss279560
Adams269582
Marion268880
Leake266273
Wayne262341
Grenada260386
Covington256381
George246848
Newton246061
Winston226881
Tishomingo225967
Jasper220848
Attala214173
Chickasaw207157
Holmes188673
Clay184754
Stone182033
Tallahatchie178140
Clarke177879
Calhoun170132
Yalobusha163337
Smith162234
Walthall133845
Greene130333
Lawrence128323
Montgomery126742
Noxubee126734
Perry125938
Amite122842
Carroll121728
Webster114532
Jefferson Davis106932
Tunica104826
Claiborne102230
Benton99125
Humphreys96133
Kemper95428
Franklin83623
Quitman80216
Choctaw76118
Wilkinson66930
Jefferson65428
Sharkey50317
Issaquena1686
Unassigned00

Alabama Coronavirus Cases

Cases: 530325

Reported Deaths: 10966
CountyCasesDeaths
Jefferson763971520
Mobile40908804
Madison34717503
Tuscaloosa25730452
Montgomery24314588
Shelby23401249
Baldwin21107307
Lee15856171
Calhoun14488314
Morgan14282279
Etowah13819353
Marshall12210223
Houston10557280
Elmore10044205
Limestone9954150
Cullman9649193
St. Clair9644242
Lauderdale9419241
DeKalb8825185
Talladega8214175
Walker7223277
Autauga6918108
Jackson6804112
Blount6651137
Colbert6292134
Coffee5506119
Dale4828111
Russell440638
Chilton4279112
Franklin425582
Covington4118118
Tallapoosa4019152
Escambia393276
Chambers3559123
Dallas3547151
Clarke350861
Marion3113100
Pike310577
Lawrence299898
Winston274072
Bibb260464
Marengo249264
Geneva249077
Pickens234160
Barbour230757
Hale222677
Butler215969
Fayette212062
Henry188744
Cherokee184445
Randolph179941
Monroe177340
Washington167039
Macon158750
Clay156156
Crenshaw152057
Cleburne148741
Lamar141934
Lowndes138653
Wilcox127030
Bullock123041
Conecuh110129
Perry107526
Coosa107128
Sumter104332
Greene92334
Choctaw60424
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