Allergy warning for Pfizer/BioNTech vaccine after UK health workers with allergy history suffer reaction

People with a "significant history of allergic reactions" should not be given the Pfizer/BioNTech...

Posted: Dec 9, 2020 9:35 AM
Updated: Dec 10, 2020 7:15 AM

People with a 'significant history of allergic reactions' should not be given the Pfizer/BioNTech coronavirus vaccine, UK health authorities said Wednesday, after two health care workers experienced symptoms after receiving a shot the day before.

The precautionary advice was given after the pair 'responded adversely' following their shots on the first day of the mass vaccination rollout in the UK, National Health Service England said Wednesday.

The two staff members -- who both carried an adrenaline auto injector and had a history of allergic reactions -- developed symptoms of anaphylactoid reaction after receiving the vaccine on Tuesday. Thousands overall were vaccinated in the UK on Tuesday, NHS England told CNN on Wednesday.

'As is common with new vaccines the MHRA [Medicines and Healthcare products Regulatory Agency] have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday,' said Stephen Powis, the national medical director for NHS England, in a statement. 'Both are recovering well.'

The MHRA issued new advice to health care professionals stating that any person with a significant allergic reaction to a vaccine, medicine or food -- such as previous history of anaphylactoid reaction, or those who have been advised to carry an adrenaline autoinjector -- should not receive the Pfizer/BioNtech vaccine.

The advice also states that vaccines 'should only be carried out in facilities where resuscitation measures are available.'

'We are fully investigating the two reports that have been reported to us as a matter of priority,' an MHRA spokesperson said.

'Once all the information has been reviewed we will communicate updated advice,' the spokesperson added.

They advised anyone with a history of a significant allergic reaction due to receive the Pfizer/BioNTech vaccine to speak to the health care professional administering the vaccine.

Pfizer said in a statement that it had been advised by the UK regulator of 'two yellow card reports that may be associated with allergic reaction' due to administration of the vaccine.

'As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation,' the statement said.

'In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.'

Documents released on Tuesday by the US Food and Drug Administration (FDA) said the Pfizer/BioNTech trial data indicated that there were potentially slightly more adverse responses thought to be allergic reactions among the vaccine group compared with the placebo group, at 0.63% compared with 0.51%.

Pfizer's trial protocol shows that people with a history of severe allergic reaction (e.g., anaphylaxis) 'to any component of the study intervention' were not able to take part.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told the UK's Science Media Centre that the increase was only 'small' but said there was 'a lot of uncertainty around that estimate.'

He said that 'some people won't know if they have hypersensitivity to some constituents of the vaccine.'

He backed the MHRA advice for people who carry an EpiPen to delay having a vaccination until the reason for the allergic reaction has been clarified. But he said the news did not mean the general public should be anxious.

Peter Openshaw, professor of experimental medicine at Imperial College London, said: 'As with all food and medications, there is a very small chance of an allergic reaction to any vaccine.

'The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.'

Vaccine expert Dr. Paul Offit told CNN that allergic reactions to vaccines were not uncommon: 'Certainly, vaccines can cause severe allergic reactions. In the United States, roughly one of every 1.4 million doses of vaccines is complicated by a severe allergic reaction.'

He said that rather than a 'blanket recommendation' for people with allergies, 'the smarter thing to do would be to try and look at these two patients and see what specific component of the vaccine they were allergic to.'

Offit said people should realize that there are immediate treatments for allergic reaction. 'That's why you're hanging out in the doctor's office,' he said, before warning that the reports of allergic reactions 'will only serve as yet another way to scare people.'

Saffron Cordery, deputy chief executive of NHS Providers, told Sky News on Sunday that the authorization and approval process for the Pfizer/BioNTech vaccine 'has been incredibly robust.' The head of Britain's medicines regulator also put out assurances on Sunday, saying the Pfizer/BioNTech shot was 'as safe as any general vaccine.'

US drug giant Pfizer and German company BioNTech have said there are 'no serious safety concerns' over the vaccine.

The US Centers for Disease Control and Prevention typically advises telling a provider if you have 'any severe, life-threatening allergies' before taking any vaccine.

Allergies are also a consideration with other Covid-19 vaccines that have not yet been approved.

During Chinese company Sinovac's Phase 2 trial, one volunteer in the high dose group had a severe allergic reaction within 48 hours of the first dose, which researchers said may be related to the vaccine. The volunteer was treated for the reaction and recovered within three days. The same volunteer did not have a similar allergic reaction to the second shot.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 313166

Reported Deaths: 7228
CountyCasesDeaths
DeSoto21496257
Hinds20294414
Harrison17814309
Rankin13573278
Jackson13411246
Madison10066217
Lee9962173
Jones8364163
Forrest7649152
Lauderdale7181240
Lowndes6370145
Lamar621686
Lafayette6171118
Washington5323133
Bolivar4797132
Oktibbeha461498
Panola4561105
Pearl River4499145
Marshall4397103
Warren4380121
Pontotoc419572
Monroe4100133
Union409076
Neshoba4026176
Lincoln3950110
Hancock377786
Leflore3487125
Sunflower335790
Tate332484
Pike3301105
Scott315373
Alcorn311968
Yazoo310769
Itawamba299477
Copiah296465
Simpson294788
Coahoma294379
Tippah287768
Prentiss279560
Adams269582
Marion268880
Leake266273
Wayne262341
Grenada260386
Covington256381
George246848
Newton246061
Winston226881
Tishomingo225967
Jasper220848
Attala214173
Chickasaw207157
Holmes188673
Clay184754
Stone182033
Tallahatchie178140
Clarke177879
Calhoun170132
Yalobusha163337
Smith162234
Walthall133845
Greene130333
Lawrence128323
Montgomery126742
Noxubee126734
Perry125938
Amite122842
Carroll121728
Webster114532
Jefferson Davis106932
Tunica104826
Claiborne102230
Benton99125
Humphreys96133
Kemper95428
Franklin83623
Quitman80216
Choctaw76118
Wilkinson66930
Jefferson65428
Sharkey50317
Issaquena1686
Unassigned00

Alabama Coronavirus Cases

Cases: 530988

Reported Deaths: 10978
CountyCasesDeaths
Jefferson765291522
Mobile40971804
Madison34751503
Tuscaloosa25775452
Montgomery24329589
Shelby23431249
Baldwin21131308
Lee15884171
Calhoun14501314
Morgan14293279
Etowah13831353
Marshall12222223
Houston10567281
Elmore10061205
Limestone9960151
Cullman9664193
St. Clair9655243
Lauderdale9424241
DeKalb8830186
Talladega8223176
Walker7235277
Autauga6920108
Jackson6810112
Blount6660137
Colbert6298134
Coffee5511119
Dale4831111
Russell441138
Chilton4290112
Franklin425782
Covington4121118
Tallapoosa4027152
Escambia393376
Chambers3563123
Dallas3551151
Clarke351061
Marion3118101
Pike310877
Lawrence300298
Winston274472
Bibb260764
Geneva249977
Marengo249764
Pickens234461
Barbour230857
Hale222977
Butler215969
Fayette212362
Henry188744
Cherokee184845
Randolph180241
Monroe177440
Washington167339
Macon159150
Clay156256
Crenshaw152257
Cleburne148941
Lamar142535
Lowndes138853
Wilcox127130
Bullock123041
Conecuh110529
Perry107726
Coosa107228
Sumter104532
Greene92334
Choctaw60624
Out of AL00
Unassigned00
Tupelo
Cloudy
58° wxIcon
Hi: 65° Lo: 57°
Feels Like: 58°
Columbus
Cloudy
60° wxIcon
Hi: 66° Lo: 61°
Feels Like: 60°
Oxford
Cloudy
54° wxIcon
Hi: 65° Lo: 53°
Feels Like: 54°
Starkville
Cloudy
55° wxIcon
Hi: 65° Lo: 58°
Feels Like: 55°
A frontal system to the south of our area will linger for a few more days. This lingering will linger some more chances for some showers and thunderstorms in our weather forecast over the next few days.
WTVA Radar
WTVA Temperatures
WTVA Severe Weather