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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


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: 248189

Reported Deaths: 5411
CountyCasesDeaths
DeSoto16841171
Hinds15890312
Harrison13037191
Rankin10439205
Jackson10128177
Lee8721135
Madison8071160
Jones6166108
Forrest5870117
Lauderdale5724177
Lowndes5238109
Lafayette486192
Lamar475363
Washington4734122
Bolivar3941106
Oktibbeha388179
Panola360475
Pontotoc358752
Monroe3487103
Warren337895
Union337457
Marshall336065
Neshoba3325150
Pearl River319492
Leflore2980104
Lincoln293385
Sunflower277569
Tate266659
Alcorn260651
Itawamba258858
Pike258176
Hancock253557
Prentiss242450
Scott241043
Yazoo237754
Copiah237449
Tippah236246
Simpson232367
Leake227864
Coahoma223154
Grenada215770
Covington208871
Marion206171
Adams201666
Winston198061
George197438
Wayne196130
Attala191658
Newton186542
Chickasaw181243
Tishomingo179659
Holmes167867
Jasper165134
Clay156732
Stone140218
Tallahatchie138234
Clarke136460
Calhoun133321
Smith118823
Yalobusha113834
Walthall111136
Noxubee109622
Greene108929
Montgomery108134
Carroll103721
Lawrence101217
Perry99131
Amite96425
Webster90624
Claiborne85125
Tunica84521
Jefferson Davis83825
Humphreys81524
Benton80323
Kemper75720
Quitman6758
Franklin65315
Choctaw59613
Wilkinson58125
Jefferson53019
Sharkey42417
Issaquena1586
Unassigned00

Alabama Coronavirus Cases

Cases: 417528

Reported Deaths: 6030
CountyCasesDeaths
Jefferson61313888
Mobile29768542
Madison26637185
Tuscaloosa20580268
Montgomery18696304
Shelby18310113
Baldwin16002179
Lee12261101
Morgan12093112
Etowah11604157
Calhoun10982200
Marshall10108107
Houston8474129
Cullman7960104
Limestone790174
Elmore7723101
DeKalb764697
St. Clair7460120
Lauderdale745183
Talladega6102108
Walker5852174
Jackson574441
Blount526483
Colbert525670
Autauga510355
Coffee434256
Dale391081
Franklin363445
Chilton333565
Covington326167
Russell323810
Escambia312442
Dallas300296
Clarke278233
Chambers277869
Tallapoosa2599107
Pike245829
Marion240549
Lawrence240447
Winston223835
Bibb213047
Geneva197431
Marengo197329
Pickens195231
Hale173742
Barbour171236
Butler167958
Fayette166026
Cherokee159630
Henry151119
Monroe144417
Randolph138535
Washington136526
Clay125246
Crenshaw118044
Lamar116619
Cleburne116023
Macon113335
Lowndes108735
Wilcox101221
Bullock98128
Perry95419
Conecuh92920
Sumter88726
Greene75323
Coosa60414
Choctaw51224
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