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
Updated: 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: 331863

Reported Deaths: 7494
CountyCasesDeaths
DeSoto22855279
Hinds22625437
Harrison19462326
Rankin14765286
Jackson14233251
Madison10658227
Lee10398178
Jones8713169
Forrest8164157
Lauderdale7528243
Lowndes6761150
Lamar665988
Lafayette6446124
Washington5497139
Bolivar4907134
Pearl River4889149
Oktibbeha476898
Panola4719112
Marshall4648106
Warren4612125
Pontotoc438873
Monroe4243137
Union424379
Neshoba4179180
Lincoln4088115
Hancock402788
Leflore3562125
Pike3511111
Tate348988
Alcorn343174
Sunflower342293
Adams331987
Yazoo330573
Scott330175
Simpson313690
Copiah311467
Itawamba309580
Coahoma308285
Tippah298368
Prentiss292563
Covington280183
Marion278980
Leake277975
Wayne269942
Grenada265688
George259851
Newton256064
Tishomingo235769
Winston235084
Jasper225748
Attala220373
Chickasaw215960
Stone209137
Holmes194974
Clay191554
Tallahatchie181542
Clarke181480
Calhoun177332
Smith175334
Yalobusha169240
Walthall140448
Lawrence137026
Greene134934
Amite131843
Noxubee131135
Perry130838
Montgomery130644
Carroll124531
Webster116732
Jefferson Davis112934
Tunica110827
Benton104425
Claiborne104231
Kemper100329
Humphreys99033
Franklin85923
Quitman83519
Choctaw80919
Wilkinson73232
Jefferson69028
Sharkey51518
Issaquena1696
Unassigned00

Alabama Coronavirus Cases

Cases: 565510

Reported Deaths: 11468
CountyCasesDeaths
Jefferson828061584
Mobile44938853
Madison36534532
Tuscaloosa26589465
Shelby26409255
Montgomery25598623
Baldwin23319324
Lee16691179
Calhoun15030332
Morgan14877288
Etowah14563368
Marshall12723235
Houston11302292
Elmore10576217
St. Clair10449251
Limestone10420158
Cullman10198204
Lauderdale9883253
DeKalb9226191
Talladega8705187
Walker7545286
Autauga7388113
Jackson7216117
Blount7147139
Colbert6522142
Coffee5962131
Dale5224117
Russell463942
Chilton4603117
Covington4502125
Franklin439781
Tallapoosa4343156
Escambia414782
Chambers3813124
Dallas3674163
Clarke361562
Marion3354106
Pike323179
Lawrence3176101
Winston289672
Bibb276165
Geneva267383
Marengo257367
Barbour241860
Pickens238862
Butler233571
Hale230578
Fayette223863
Henry203345
Cherokee192347
Randolph192244
Monroe190241
Washington174539
Macon167252
Crenshaw163457
Clay161859
Cleburne158445
Lamar149138
Lowndes143854
Wilcox128431
Bullock125342
Conecuh117730
Coosa115229
Perry109628
Sumter107532
Greene95935
Choctaw63125
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