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: 501097

Reported Deaths: 9990
CountyCasesDeaths
Harrison34338538
DeSoto32117403
Hinds31939628
Jackson24494382
Rankin21995390
Lee15543235
Madison14581280
Jones13851242
Forrest13453251
Lauderdale11991317
Lowndes11050188
Lamar10521135
Pearl River9533237
Lafayette8550140
Hancock7732127
Washington7438158
Oktibbeha7146131
Monroe6777177
Warren6694176
Pontotoc6664102
Neshoba6637206
Panola6531131
Marshall6467134
Bolivar6317148
Union602894
Pike5820152
Alcorn5669101
Lincoln5436135
George496879
Scott472898
Tippah469281
Prentiss467281
Leflore4658144
Itawamba4636105
Tate4588111
Adams4587119
Copiah448592
Simpson4446116
Yazoo444187
Wayne439772
Covington428894
Sunflower4239105
Marion4226108
Coahoma4160105
Leake408288
Newton381779
Grenada3707108
Stone360364
Tishomingo359792
Attala331589
Jasper329965
Winston314291
Clay308076
Chickasaw300367
Clarke292494
Calhoun279446
Holmes267987
Smith264050
Yalobusha234047
Tallahatchie228051
Greene219348
Walthall218763
Lawrence212940
Perry205556
Amite205156
Webster202946
Noxubee186740
Montgomery179656
Jefferson Davis171743
Carroll169138
Tunica159839
Benton148838
Kemper141941
Choctaw133426
Claiborne132737
Humphreys129538
Franklin120228
Quitman106428
Wilkinson105139
Jefferson94534
Sharkey64120
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 820011

Reported Deaths: 15407
CountyCasesDeaths
Jefferson1148361924
Mobile726091339
Madison52337697
Shelby37622350
Baldwin37258552
Tuscaloosa35117612
Montgomery34116740
Lee23536246
Calhoun22232488
Morgan20952378
Etowah19834500
Marshall18372304
Houston17390412
St. Clair16064339
Cullman15454293
Limestone15349199
Elmore15264286
Lauderdale14314295
Talladega13842283
DeKalb12662261
Walker11206370
Blount10197176
Autauga10047148
Jackson9874184
Coffee9211191
Dale8900185
Colbert8871201
Tallapoosa7089198
Escambia6775134
Covington6713183
Chilton6645162
Russell637059
Franklin5962105
Chambers5610142
Marion5007127
Dallas4975200
Pike4796106
Clarke475784
Geneva4574127
Winston4519103
Lawrence4324117
Bibb425286
Barbour357876
Marengo338390
Monroe331564
Randolph329764
Butler326496
Pickens316384
Henry312766
Hale311688
Cherokee302860
Fayette294180
Washington251651
Cleburne247760
Crenshaw245275
Clay243368
Macon234863
Lamar224447
Conecuh186253
Coosa180240
Lowndes175364
Wilcox168939
Bullock151744
Perry138840
Sumter133238
Greene126744
Choctaw88527
Out of AL00
Unassigned00
Tupelo
Clear
50° wxIcon
Hi: 70° Lo: 49°
Feels Like: 50°
Columbus
Clear
49° wxIcon
Hi: 71° Lo: 50°
Feels Like: 49°
Oxford
Clear
46° wxIcon
Hi: 68° Lo: 47°
Feels Like: 46°
Starkville
Clear
50° wxIcon
Hi: 70° Lo: 50°
Feels Like: 50°
High pressure will dominate our weather forecast for our Tuesday. This means we will see some good weather for our Tuesday. However, some rain and thunderstorms will be in our weather forecast down the line with some more low pressure in our area.
WTVA Radar
WTVA Temperatures
WTVA Severe Weather