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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: 501652

Reported Deaths: 10024
CountyCasesDeaths
Harrison34353540
DeSoto32162408
Hinds31977631
Jackson24508383
Rankin22015390
Lee15596235
Madison14597280
Jones13867243
Forrest13461252
Lauderdale11998317
Lowndes11065188
Lamar10522136
Pearl River9547237
Lafayette8557140
Hancock7740127
Washington7443160
Oktibbeha7147133
Monroe6787178
Warren6706176
Pontotoc6677104
Neshoba6642206
Panola6542131
Marshall6476135
Bolivar6323150
Union605794
Pike5824152
Alcorn5676102
Lincoln5439135
George497479
Scott473098
Tippah470381
Prentiss469182
Leflore4663144
Itawamba4640105
Adams4592119
Tate4592111
Copiah448792
Simpson4448116
Yazoo444887
Wayne440072
Covington429094
Sunflower4240105
Marion4232108
Coahoma4168107
Leake408688
Newton381779
Grenada3711108
Stone360664
Tishomingo360092
Attala331789
Jasper330165
Winston314691
Clay308977
Chickasaw301067
Clarke292594
Calhoun279447
Holmes267987
Smith264150
Yalobusha234547
Tallahatchie228251
Greene219449
Walthall218764
Lawrence213140
Perry205956
Amite205256
Webster203046
Noxubee186840
Montgomery179657
Jefferson Davis172243
Carroll169338
Tunica160039
Benton149239
Kemper141941
Choctaw133326
Claiborne132837
Humphreys129638
Franklin120328
Quitman106528
Wilkinson105139
Jefferson94734
Sharkey64220
Issaquena1937
Unassigned00

Alabama Coronavirus Cases

Cases: 820312

Reported Deaths: 15407
CountyCasesDeaths
Jefferson1148731924
Mobile726221339
Madison52362697
Shelby37640350
Baldwin37266552
Tuscaloosa35120612
Montgomery34123740
Lee23540246
Calhoun22236488
Morgan20958378
Etowah19838500
Marshall18381304
Houston17394412
St. Clair16078339
Cullman15468293
Limestone15354199
Elmore15271286
Lauderdale14323295
Talladega13851283
DeKalb12664261
Walker11221370
Blount10207176
Autauga10048148
Jackson9877184
Coffee9211191
Dale8904185
Colbert8877201
Tallapoosa7093198
Escambia6778134
Covington6715183
Chilton6648162
Russell637559
Franklin5969105
Chambers5612142
Marion5010127
Dallas4979200
Pike4796106
Clarke475884
Geneva4575127
Winston4522103
Lawrence4327117
Bibb425386
Barbour357876
Marengo338390
Monroe331664
Randolph329864
Butler326796
Pickens316584
Henry312866
Hale311688
Cherokee302960
Fayette294180
Washington251651
Cleburne247760
Crenshaw245375
Clay243368
Macon234863
Lamar224847
Conecuh186353
Coosa180340
Lowndes175464
Wilcox168939
Bullock151744
Perry138940
Sumter133238
Greene126744
Choctaw88527
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