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UK probing if allergic reactions linked to Pfizer vaccine
By DANICA KIRKA
today

LONDON (AP) — British regulators warned Wednesday that people who have a history of serious allergic reactions shouldn’t receive the new Pfizer-BioNTech vaccine as they investigate two adverse reactions that occurred on the first day of the country’s mass vaccination program.

The U.K.’s Medical and Healthcare Products Regulatory Agency is looking into whether the reactions were linked to the vaccine. The two people affected were staff members with the National Health Service who had a history of allergies, and both are recovering. Authorities have not specified what their reactions were.

In the meantime, the regulator has issued the warning for anyone who has had a significant allergic reaction to a vaccine, medicine or food. That includes anyone who has been told to carry an adrenaline shot or others who have had potentially fatal allergic reactions.

“As is common with new vaccines the MHRA 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,” Professor Stephen Powis, medical director for the NHS in England, said in a statement. “Both are recovering well.”

The medical regulatory agency also said vaccinations should not be carried out in facilities that don’t have resuscitation equipment.

Pfizer and BioNTech said they were working with investigators “to better understand each case and its causes.″

Late-stage trials of the vaccine found “no serious safety concerns,” the companies said. More than 42,000 people have received two doses of the shot during those trials.

“In the pivotal phase three clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee,” the companies said.

Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who weren’t previously known to have severe allergies.

Even in non-emergency situations, health authorities must closely monitor new vaccines and medications because studies in tens of thousands of people can’t detect a rare risk that would affect 1 in 1 million.

Dr. Peter Openshaw, a professor of experimental medicine at Imperial College London, said there is a “very small” chance of an allergic reaction to any vaccine.

The MHRA last week gave emergency authorization to the Pfizer-BioNTech vaccine, making Britain the first country to allow its widespread use.

The U.K. began its mass vaccination program on Tuesday, offering the shot to people over 80, nursing home staff and some NHS workers. It’s not clear how many people have received the jab so far.
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As part of its emergency authorization for the vaccine, the MHRA required healthcare workers to report any adverse reactions to help regulators gather more information about safety and effectiveness.

The agency is monitoring the vaccine rollout closely and “will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental,” he said. “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.”

Dr. June Raine, head of the medical regulatory agency, informed a Parliamentary committee about the reactions during previously scheduled testimony on the pandemic.

“We know from the very extensive clinical trials that this wasn’t a feature” of the vaccine, she said. “But if we need to strengthen our advice, now that we have had this experience in the vulnerable populations, the groups who have been selected as a priority, we get that advice to the field immediately.”

https://apnews.com/article/uk-allergic-r...80da27941db3540

UK Requires ‘Resuscitation Facilities’ at Corona Vaccine Centres After Allergic Reactions
Kurt Zindulka
9 Dec 20201,942

Britain’s National Health Service (NHS) confirmed on Wednesday that it is deploying “resuscitation facilities” in coronavirus vaccination centres following the revelation that two healthcare workers suffered anaphylactoid reactions after receiving the Pfizer/BioNTech vaccine on the first day of rollout.

Following the adverse reactions experienced by the two healthcare workers, the Medicines and Healthcare products Regulatory Agency (MHRA) issued “precautionary advice” which said that people who have a “history of a significant reaction” to medicines, foods, or vaccines should avoid taking the coronavirus vaccine.

The new advice went on to state: “Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.”

In comments made to Breitbart London on Wednesday, NHS England and NHS Improvement spokesman Matthew Edwards said that “vaccination hubs all follow the guidelines set by the MHRA”.

The NHS also said that it is seeking “further information and will issue further advice following investigation”.

Breitbart London approached the MHRA for comment but the medical body did not respond by the time of publication.

The NHS describes anaphylaxis as a “severe and potentially life-threatening reaction to a trigger such as an allergy,” which is the result of the body’s immune system “overreacting to a trigger” such as certain types of medication.

A professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, Stephen Evans said: “Allergic reaction occurs with quite a number of vaccines, and perhaps even more frequently with drugs. So it is not unexpected.”

“The Pfizer data showed that about 0.6% of people had some form of allergic reaction in the trial on the vaccine, but about 0.5% on placebo. So there was a genuine excess of allergic reaction but this was small and the true rate is not known, and there is a lot of uncertainty around that estimate.

“The only thing that is contraindicated with this vaccine (meaning you mustn’t have it) is hypersensitivity to the vaccine or any of the excipients (other things in the vaccine), but some people won’t know if they have hypersensitivity to some constituents of the vaccine.”

Professor Evans said that it would “be wise” for those who have a history of allergic relations, such as those who need to carry an autoinjector like EpiPens, to put off taking the vaccine “until the reason for the allergic reaction has been clarified.”

The British healthcare system has previously warned that women who are pregnant or are breastfeeding should avoid taking the vaccine until more information becomes available.

On Tuesday, the United Kingdom began to roll out the vaccine developed by the American company Pfizer and Germany’s BioNTech, which is the first coronavirus vaccine in humans to be adopted by any Western nation.

https://www.breitbart.com/europe/2020/12...e-jab-15198362/