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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: 387485

Reported Deaths: 5116
CountyCasesDeaths
Multnomah59768836
Washington41571393
Marion39592504
Clackamas32426376
Lane29856354
Jackson24672350
Deschutes23182185
Umatilla15087180
Linn14488178
Douglas13236286
Josephine10057240
Yamhill9665142
Klamath8979145
Polk813698
Benton605137
Malheur591586
Coos5573106
Columbia423855
Jefferson416865
Lincoln357252
Union336854
Crook330156
Wasco314846
Clatsop258335
Baker217531
Tillamook214345
Hood River211337
Morrow197025
Curry190136
Harney119332
Grant108314
Lake104016
Wallowa74713
Sherman1903
Gilliam1844
Wheeler1141
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 5057759

Reported Deaths: 74098
CountyCasesDeaths
Los Angeles152224027074
San Diego4047084319
Riverside3849455306
San Bernardino3718825944
Orange3329505675
Sacramento1674002423
Kern1565171781
Fresno1558992246
Santa Clara1511691922
Alameda1246581499
San Joaquin1070001833
Ventura1036461188
Contra Costa1032921045
Stanislaus910641413
Tulare856141082
San Francisco56614669
San Mateo56058627
Monterey52340625
Solano47422356
Santa Barbara47035548
Merced44807664
Sonoma42912412
Placer41881468
Imperial38128769
Kings35038358
San Luis Obispo31294358
Madera26005311
Shasta25917440
Butte25295309
Santa Cruz22028222
Yolo21451257
Marin18342248
El Dorado18166161
Sutter14494181
Napa13372104
Yuba1070088
Tehama10230129
Humboldt10043117
Nevada9914103
Mendocino848894
Lassen792355
San Benito775977
Tuolumne767790
Lake6990110
Amador573766
Siskiyou470954
Glenn455136
Calaveras435685
Del Norte371242
Colusa323519
Inyo254345
Plumas19127
Mono18294
Mariposa156718
Trinity98817
Modoc7475
Unassigned2430
Sierra2170
Alpine1060
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