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: 149940

Reported Deaths: 3779
CountyCasesDeaths
DeSoto10097104
Hinds9984199
Harrison7116110
Jackson6360119
Rankin5588103
Lee509195
Madison4799106
Forrest383186
Jones357688
Lauderdale3496147
Lafayette326051
Washington3179107
Lamar291550
Oktibbeha245462
Bolivar241384
Lowndes237364
Panola222350
Neshoba2206118
Marshall217250
Leflore205590
Pontotoc199928
Monroe198177
Sunflower191655
Lincoln190865
Warren176857
Tate169851
Union167325
Copiah164140
Pike162658
Yazoo156039
Scott154829
Itawamba152935
Pearl River152167
Alcorn151328
Coahoma150543
Simpson148353
Prentiss146230
Adams141950
Grenada140945
Leake134944
Holmes130861
George125524
Tippah125230
Covington123439
Winston122224
Hancock121139
Wayne117923
Marion116646
Attala113034
Tishomingo109442
Chickasaw107632
Newton105629
Tallahatchie97027
Clay91327
Clarke90553
Jasper82822
Stone77014
Walthall76928
Calhoun75513
Montgomery74525
Carroll72415
Lawrence71814
Smith71316
Yalobusha71327
Noxubee71017
Perry67026
Tunica61019
Greene60322
Claiborne58616
Jefferson Davis57017
Amite54014
Humphreys53619
Benton49318
Quitman4927
Webster44314
Kemper43618
Wilkinson39822
Jefferson35211
Franklin3395
Choctaw3357
Sharkey30917
Issaquena1164
Unassigned00

Alabama Coronavirus Cases

Cases: 244993

Reported Deaths: 3572
CountyCasesDeaths
Jefferson32314500
Mobile19859361
Madison13223148
Tuscaloosa13049154
Montgomery12342236
Shelby1031577
Baldwin873398
Lee775766
Morgan662650
Calhoun6301119
Etowah627666
Marshall627255
Houston525638
DeKalb485536
Cullman439442
Limestone425145
St. Clair419555
Lauderdale407854
Elmore406864
Walker3657111
Talladega351454
Jackson320423
Colbert311942
Blount292240
Autauga273542
Franklin252633
Coffee245415
Dale232654
Dallas226232
Chilton223438
Russell22193
Covington218934
Escambia198331
Chambers176850
Tallapoosa176391
Pike158614
Clarke158419
Marion140236
Winston133023
Lawrence127936
Pickens123518
Geneva12218
Marengo121524
Bibb117917
Barbour117310
Butler116541
Randolph102921
Cherokee102224
Hale97031
Clay91924
Fayette91616
Washington91219
Henry8546
Lowndes79929
Monroe78911
Cleburne77214
Macon73722
Crenshaw71130
Bullock69619
Perry6886
Conecuh68414
Lamar6798
Wilcox63518
Sumter58122
Greene42618
Choctaw42213
Coosa3444
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