Pfizer has enough safety data about its coronavirus vaccine and is preparing to submit for FDA authorization, CEO says

Pfizer has accumulated enough safety data on its Covid-19 vaccine and is preparing to file for emergency use authorization from the US Food and Drug Administ...

Posted: Nov 18, 2020 2:07 AM

Pfizer has accumulated enough safety data on its Covid-19 vaccine and is preparing to file for emergency use authorization from the US Food and Drug Administration, company CEO Albert Bourla said Tuesday.

Last week, the company released early clinical trial data showing its vaccine is more than 90% effective, and said it was waiting to apply to the FDA until it had gathered sufficient data on the safety of the vaccine.

"I think the questions about the safety at large also have been answered," Bourla said in an interview hosted by The New York Times on Tuesday. "Our safety milestone has been achieved already, and we are preparing now for submissions."

Moderna, another pharmaceutical company, announced Monday that early results from their clinical trials show their vaccine is 94.5% effective. The company plans to apply to the FDA for authorization soon after it accumulates more safety data later this month.

Dr. Anthony Fauci, the nation's top infectious disease doctor, told CNN this week that Americans will likely start getting vaccinated "towards the latter part of December."

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, for December 8, 9 and 10, a source familiar with the process told CNN Tuesday.

The agency could make a decision at the end of the meeting on December 10 about whether to issue emergency use authorizations for the vaccines, the source said.

"It will make sense that in all likelihood the FDA will consider both applications together," the source said, considering that both vaccines use the same technology and appear to have very similar safety and efficacy results from their large-scale Phase 3 clinical trials.

What happens after an EUA

If the FDA authorizes the vaccines, they can then be immediately distributed to states, according to a presentation made last month at the US Centers for Disease Control and Prevention.

However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and says which groups will receive it first.

If the FDA authorizes the vaccines, the CDC's Advisory Committee on Immunization Practices, an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson.

At that meeting, the committee will determine if everyone should get the vaccine, or if some people should be excluded. It will also decide which groups should get the vaccine first.

"We have all been alerted on ACIP we should be very flexible with our calendars because it's likely there won't be a lot of advanced notice given for this meeting. It will be done very, very quickly," said Dr. William Schaffner, a committee member.

Once ACIP issues its recommendations, vaccinations can be given.

States are currently working out the details of running vaccination clinics. The Pfizer vaccine is particularly complicated, since it must be stored at minus 75 degrees Celsius, and doctors' offices and pharmacies typically do not have freezers that go that low.

The first groups expected to receive the vaccine are health care workers, the elderly, essential works such as police officers, and those with underlying medical conditions.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 178110

Reported Deaths: 2468
CountyCasesDeaths
Multnomah35509570
Washington23824229
Marion20503299
Clackamas15674204
Lane11854144
Jackson10123129
Umatilla800883
Deschutes736872
Linn425664
Yamhill415575
Klamath362559
Polk350352
Malheur343558
Josephine311762
Douglas307066
Benton280219
Jefferson208332
Coos199231
Columbia157526
Union142024
Wasco132028
Lincoln131220
Hood River114029
Morrow108515
Clatsop9118
Crook90719
Baker88114
Curry6069
Tillamook5893
Grant4314
Lake4197
Harney3156
Wallowa1585
Gilliam571
Sherman571
Wheeler261
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3727913

Reported Deaths: 61309
CountyCasesDeaths
Los Angeles123039823736
Riverside2977704555
San Bernardino2953154572
San Diego2759123684
Orange2693524910
Santa Clara1175382025
Kern1081311335
Sacramento1019061653
Fresno1008381654
Alameda857621481
Ventura803981002
San Joaquin718991340
Contra Costa67300782
Stanislaus606771035
Tulare49469831
Monterey43346380
San Mateo41318560
San Francisco36194529
Santa Barbara33926445
Solano32126244
Merced31321454
Sonoma29747318
Imperial28052719
Kings22825246
Placer21979283
San Luis Obispo21038260
Madera16309240
Santa Cruz15759204
Marin13883227
Yolo13606205
Shasta11779219
Butte11643196
El Dorado9831109
Napa973779
Sutter9322110
Yuba613844
San Benito599863
Lassen568524
Tehama545957
Nevada450575
Tuolumne409164
Mendocino399847
Humboldt369738
Amador363247
Lake342143
Glenn236125
Colusa220816
Calaveras206652
Siskiyou197921
Inyo141938
Del Norte12927
Mono12744
Plumas6976
Modoc4924
Mariposa4317
Trinity3985
Sierra1100
Alpine880
Unassigned680
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