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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 9:34 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: 343505

Reported Deaths: 7543
CountyCasesDeaths
Hinds23932444
DeSoto23229283
Harrison20527329
Rankin15411291
Jackson15232252
Madison10959227
Lee10719179
Jones9047169
Forrest8723159
Lauderdale7884244
Lowndes7054151
Lamar702989
Lafayette6548124
Washington5595139
Pearl River5196152
Bolivar4954134
Oktibbeha494398
Panola4771112
Warren4728128
Marshall4701106
Pontotoc447773
Union433279
Monroe4330137
Neshoba4281181
Hancock428088
Lincoln4176116
Pike3667113
Leflore3627125
Tate353388
Alcorn350974
Sunflower347694
Scott341176
Adams340988
Yazoo339376
Copiah324968
Simpson322891
Itawamba314680
Coahoma314085
Tippah306568
Prentiss298863
Covington293484
Leake285475
Marion284181
Wayne277543
George272251
Grenada269488
Newton262364
Tishomingo239770
Winston236784
Jasper230648
Stone229637
Attala226373
Chickasaw219060
Holmes200174
Clay197654
Clarke186880
Tallahatchie183742
Calhoun181332
Smith179235
Yalobusha171540
Walthall145748
Lawrence142826
Greene140134
Amite137543
Noxubee135235
Perry133538
Montgomery133044
Carroll126431
Webster121232
Jefferson Davis116734
Tunica114227
Benton106725
Claiborne105331
Kemper102429
Humphreys100133
Franklin87923
Quitman84719
Choctaw82619
Wilkinson78032
Jefferson71328
Sharkey51618
Issaquena1736
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Alabama Coronavirus Cases

Cases: 585607

Reported Deaths: 11536
CountyCasesDeaths
Jefferson851431591
Mobile48584864
Madison37411533
Shelby27192257
Tuscaloosa27145465
Montgomery26119627
Baldwin25207329
Lee17184181
Calhoun15382334
Morgan15147291
Etowah14928370
Marshall13079235
Houston12021293
Elmore10890219
St. Clair10737252
Limestone10699158
Cullman10503205
Lauderdale10240254
DeKalb9498192
Talladega8935188
Walker7775288
Autauga7537114
Jackson7384117
Blount7352139
Colbert6691142
Coffee6342132
Dale5605117
Russell478943
Chilton4763117
Covington4738125
Franklin456681
Tallapoosa4511156
Escambia439283
Chambers3936125
Dallas3742163
Clarke370563
Marion3455107
Pike332079
Lawrence3257100
Winston298373
Bibb289765
Geneva282883
Marengo262267
Barbour250661
Pickens245262
Butler240172
Hale235178
Fayette226765
Henry212845
Monroe201541
Randolph200344
Cherokee198848
Washington184339
Macon169752
Crenshaw167758
Clay165659
Cleburne161145
Lamar150938
Lowndes145355
Wilcox132331
Bullock126542
Conecuh120632
Coosa118129
Perry110328
Sumter110333
Greene99137
Choctaw64425
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