SEVERE WX : Winter Storm Warning - Winter Weather Advisory View Alerts

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: 137600

Reported Deaths: 1877
CountyCasesDeaths
Multnomah29040464
Washington19216179
Marion16668247
Clackamas11989141
Lane8724113
Jackson712295
Umatilla697673
Deschutes517140
Yamhill329448
Malheur319855
Linn319449
Polk256340
Klamath252446
Josephine182636
Benton181714
Douglas175944
Jefferson173425
Union114617
Wasco111723
Columbia107518
Lincoln102717
Coos98315
Hood River97621
Morrow96310
Clatsop7075
Crook65213
Baker5825
Tillamook3692
Curry3245
Lake2485
Grant2171
Harney1806
Wallowa993
Gilliam531
Sherman470
Wheeler201
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3147735

Reported Deaths: 36846
CountyCasesDeaths
Los Angeles106550515184
San Bernardino2628581594
Riverside2585322777
San Diego2255582344
Orange2214932625
Santa Clara964351181
Kern89095590
Fresno847441043
Sacramento828611157
Alameda69693886
Ventura64404507
San Joaquin59395808
Contra Costa54416487
Stanislaus43938788
Tulare42759531
Monterey37285259
San Mateo33731340
San Francisco30027278
Santa Barbara26514264
Solano26494111
Imperial25562493
Merced25048324
Sonoma24761247
Kings19760160
Placer17675188
San Luis Obispo16437151
Madera13781151
Santa Cruz12687130
Marin11930163
Yolo11014138
Shasta9920129
Butte9711134
El Dorado800259
Sutter792783
Napa782847
Lassen526916
San Benito514348
Yuba504929
Tehama446846
Tuolumne344340
Nevada329674
Mendocino325635
Amador304232
Lake268132
Humboldt249425
Glenn198522
Colusa18549
Calaveras167223
Siskiyou148413
Mono11354
Inyo100729
Del Norte8732
Plumas6055
Modoc3873
Mariposa3464
Trinity3054
Sierra880
Alpine730
Unassigned00
Medford
Cloudy
38° wxIcon
Hi: 35° Lo: 28°
Feels Like: 38°
Brookings
Cloudy
37° wxIcon
Hi: 38° Lo: 31°
Feels Like: 37°
Medford
Cloudy
39° wxIcon
Hi: 21° Lo: 14°
Feels Like: 35°
Medford
Cloudy
39° wxIcon
Hi: 39° Lo: 28°
Feels Like: 35°
Klamath Falls
Cloudy
28° wxIcon
Hi: 31° Lo: 21°
Feels Like: 23°
Coastal rain, inland spotty snow showers tonight
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events