FDA issues emergency use authorization for Pfizer/BioNTech Covid-19 vaccine

The US Food and Drug Administration has authorized the first Covid-19 vaccine for emergency use in the United States.

Posted: Dec 11, 2020 9:38 PM
Updated: Dec 12, 2020 10:22 AM

The US Food and Drug Administration has authorized the first Covid-19 vaccine for emergency use in the United States.

Millions of doses of the Pfizer and BioNTech coronavirus vaccine, which has been found to be 95% effective, will be soon shipped around the country so vaccinations can begin within days.

Pfizer COVID-19 Vaccine

An emergency use authorization means what its name suggests: a medical product gets special authorization by the FDA to be used during an emergency -- but it is short of a full approval. Pfizer would have to file a separate application for its vaccine to be fully licensed by the FDA.

'The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,' FDA Commissioner Dr. Stephen Hahn said in a statement on Friday.

'Today's action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency's career scientists to ensure this vaccine met FDA's rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

'The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.'

Before vaccinations can begin, a US Centers for Disease Control and Prevention immunization advisory committee still must vote to recommend the vaccine, and the CDC must accept that recommendation.

The Advisory Committee on Immunization Practices was scheduled to meet Saturday morning.

About 20 million people could be vaccinated in the next few weeks -- an important step toward ending the pandemic that has killed nearly 300,000 people in the United States.

But until many more are vaccinated, mitigation efforts such as wearing masks and keeping a safe distance need to continue to stop the virus from spreading.

How the vaccine works

Pfizer and BioNTech's coronavirus vaccine, called BNT162b2, is an mRNA vaccine given as two shots administered 21 days apart. One dose is to prime the body, and then a few weeks later, the second dose is to boost the response.

The messenger RNA or mRNA used in the vaccine codes for a structure called the spike glycoprotein of the virus. That's the part of the virus that it uses to attach to cells. The vaccine prompts the human body to produce copies of that protein, eliciting an immune response that leads to some protection against coronavirus infection.

Such mRNA vaccines are the newest approach to vaccine technology.

Safety and efficacy data on Pfizer and BioNTech's Covid-19 vaccine candidate published in the New England Journal of Medicine on Thursday morning.

The data come from more than 43,000 trial participants: 21,720 who were randomly given the vaccine and 21,728 who were randomly given a placebo. The data show that there were only eight Covid-19 cases among people who received the vaccine, compared with 162 cases among those given the placebo.

The paper notes that a two-dose regimen of the vaccine has an efficacy of 95% in people ages 16 and older. 'BNT162b2 was 95% effective in preventing Covid-19,' the paper's abstract notes. 'Safety over a median of 2 months was similar to that of other viral vaccines.'

However, FDA briefing documents also note that the vaccine appears to provide 'some protection' against Covid-19 following just one dose.

The documents describe the efficacy of Pfizer's vaccine in the time between the first and second dose as 52.4%, but the document notes that 'the efficacy observed after Dose 1 and before Dose 2, from a post-hoc analysis, cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks.'

In other words, 'the trial did not have a single-dose arm to make an adequate comparison.'

The document goes on to detail the safety profile of the vaccine as 'favorable' and notes that the most common adverse reactions to the vaccine have been reactions at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.

Severe adverse reactions occurred in less than 4.6% of participants, were more frequent after the second dose and were generally less frequent in older adults as compared to younger participants, according to the document. The document adds that swollen lymph nodes also may be related to vaccination.

Overall, 'there are currently insufficient data to make conclusions about the safety of the vaccine in subpopulations such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals,' according to the document.

In a FDA advisory committee meeting on Thursday, FDA official Dr. Marion Gruber said the fact sheet and prescribing information provided with Pfizer's Covid-19 vaccine will warn that people with a history of severe allergic reactions to any of the vaccine's components should not get it.

In the United Kingdom, officials are investigating adverse responses that two health care workers with a significant history of severe allergic reactions experienced after receiving the vaccine.

Vaccine distribution to begin soon

As vaccine doses get distributed across the country, state and local officials will oversee the distribution of the vaccine in their states as well as the logistics -- and health care workers and residents of long-term care facilities are prioritized to receive the vaccine first.

At this point, the number of doses each state is getting in its first shipment is fluid and, in many cases, the amount is less than what states were initially told to expect, leading states to change distribution plans.

In most cases, the first shipments of the vaccine will be transported from Pfizer's facility in Kalamazoo, Michigan, to hospital systems and pharmacies.

The distribution from vaccine production company to individual hospitals and pharmacies in each state as directed by the federal government, is different for almost every state. State health department officials are coordinating with federal officials in Operation Warp Speed. However, there is no clear roadmap that explains how this process is working simultaneously in all 50 states.

Instead, states have developed individualized vaccine distribution plans that vary slightly for each individual state's demographic and geographic needs.

CDC officials have been in close contact with state leaders about how their distribution plans will work and challenges that could crop up state to state.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 764448

Reported Deaths: 13965
CountyCasesDeaths
Marion1049701803
Lake567981029
Allen42685698
St. Joseph37253568
Hamilton37131426
Elkhart29699470
Tippecanoe23347230
Vanderburgh23106404
Porter19538327
Johnson18755391
Hendricks18012321
Madison13463345
Clark13450198
Vigo12789255
LaPorte12533224
Monroe12494178
Delaware11100198
Howard10612237
Kosciusko9736123
Hancock8707149
Bartholomew8235157
Warrick8031157
Floyd7975181
Grant7337181
Wayne7222201
Boone7145105
Morgan6886142
Marshall6323116
Dubois6267118
Cass6083111
Dearborn598578
Noble595790
Henry5939111
Jackson514677
Shelby509097
Lawrence4901127
Gibson460696
Montgomery454492
Clinton453555
DeKalb451585
Harrison450576
Whitley414745
Huntington411781
Steuben409560
Miami404073
Jasper399455
Knox387091
Putnam383762
Wabash367383
Adams351656
Ripley350471
Jefferson340486
White338954
Daviess3084100
Wells302281
Greene292285
Decatur291493
Fayette285864
Posey280435
Scott278058
LaGrange276972
Clay273048
Washington252437
Randolph247083
Jennings238149
Spencer237531
Fountain233750
Starke229859
Owen221059
Sullivan219043
Fulton207645
Jay202832
Carroll196522
Orange190556
Perry189139
Vermillion179644
Rush177027
Franklin171635
Tipton171547
Parke153616
Pike141234
Blackford137832
Pulaski122948
Newton122436
Benton109215
Brown105743
Crawford105116
Martin92515
Warren87615
Switzerland8308
Union73510
Ohio58211
Unassigned0428

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1122104

Reported Deaths: 20467
CountyCasesDeaths
Franklin1302141493
Cuyahoga1171052259
Hamilton823021259
Montgomery534221059
Summit488431014
Lucas43716832
Butler39925614
Stark33777937
Lorain25975509
Warren24887312
Mahoning22677612
Lake21448396
Clermont20360260
Delaware19105138
Licking16838227
Trumbull16770491
Fairfield16750207
Medina15818276
Greene15497254
Clark14336308
Portage13410218
Wood13332201
Allen12037245
Richland11722213
Miami10993228
Wayne9249227
Columbiana9195236
Muskingum9118137
Pickaway8735123
Tuscarawas8710254
Marion8697140
Erie8116166
Ashtabula7270179
Hancock7043134
Ross7011165
Geauga6946153
Scioto6665108
Belmont6207179
Lawrence5912104
Union590449
Jefferson5722162
Huron5624122
Sandusky5473130
Darke5436130
Seneca5376128
Washington5360111
Athens526360
Auglaize506987
Mercer490585
Shelby480997
Knox4609112
Madison447266
Ashland442698
Defiance438499
Fulton435675
Putnam4351104
Crawford4108111
Brown409462
Preble3944107
Logan391679
Clinton388666
Ottawa375381
Highland364968
Williams356178
Champaign348060
Guernsey329754
Jackson321154
Perry298350
Morrow294543
Fayette288150
Hardin279065
Henry276967
Coshocton272561
Holmes2725102
Van Wert251765
Adams249158
Gallia248950
Pike244537
Wyandot235257
Hocking222263
Carroll200649
Paulding179342
Meigs151040
Noble137739
Monroe137445
Harrison115138
Morgan111624
Vinton87217
Unassigned03
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