UK health authorities said on Wednesday that the Pfizer/BioNTech coronavirus vaccine should not be given to people with a serious history of allergic reactions after two health care staff experienced symptoms after getting a shot the day before.
“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,” said Professor Stephen Powis, medical director for the NHS in England, said in a statement.
“Both are recovering well,” he added.
The precautionary advice was issued after the pair “responded adversely” following their shots on Wednesday, National Health Service England, the first day of the mass vaccination rollout in the UK.
After getting the vaccine on Tuesday, the two team members — who also brought an adrenaline auto-injector and had a history of allergic reactions — developed signs of an anaphylactoid reaction. Overall, thousands were vaccinated on Tuesday in the UK, NHS England told CNN on Wednesday.
The MHRA [Medicines and Healthcare Products Regulatory Agency] has recommended, as is common with new vaccines, on a precautionary basis that individuals with a significant history of allergic reactions do not receive this vaccination after two individuals with a history of severe allergic reactions reacted adversely yesterday.
“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,” “Both are recovering well.
“The MHRA has released new guidance to health care professionals stating that the Pfizer/BioNtech vaccine should not be given to any person with a serious allergic reaction to a vaccine, medication or food, such as a prior history of anaphylactoid reaction, or those who have been recommended to carry an adrenaline autoinjector.
The advice also notes that vaccines should be carried out only in facilities where resuscitation steps are appropriate.
An MHRA spokesperson said “We are fully investigating the two reports that have been reported to us as a matter of priority,
“Once all the information has been reviewed we will communicate updated advice,” the spokesperson said.
To receive the Pfizer/BioNTech vaccine, they recommended those with a history of a serious allergic reaction to talk to the health care provider administering the vaccine.
Pfizer confirmed in a statement that “two yellow card reports that may be associated with the allergic reaction” due to administration of the vaccine were notified by the UK regulator.
“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 by the US Food and Drug Administration (FDA) on Tuesday said the Pfizer/BioNTech trial results showed that there were potentially significantly more adverse reactions in the vaccine community suspected to be allergic reactions compared to the placebo group, at 0.63 percent compared to 0.51 percent.
The Pfizer trial protocol indicates that it was not possible for individuals with a history of a serious allergic reaction (e.g. anaphylaxis) “to any component of the study intervention”
Stephen Evans, pharmacoepidemiology professor at the London School of Hygiene & Tropical Medicine, told the Science Media Centre of the United Kingdom that the rise was only “small” but said that 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.”
For people who hold an EpiPen, he accepted the MHRA recommendation to avoid getting a vaccine until the explanation for the allergic reaction has been explained. But he said that the news did not mean that the general public had to be nervous.
Peter Openshaw, Professor of Experimental Medicine at Imperial College London, said there is a very small chance of an allergic reaction to any vaccine, as with all food and medication.”
“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 specialist Dr. Paul Offit told CNN that it was not unusual to have allergic reactions to vaccinations: “Certainly, vaccines can cause severe allergic reactions. In the United States, roughly one of every 1.4 million doses of vaccines are complicated by a severe allergic reaction.”
He said that “blanket recommendation” instead of a “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.” for people with allergies.
Offit said people should know that immediate allergic reaction therapies are available. “That’s why you’re hanging out in the doctor’s office,” he said, warning that allergic reaction reports “will only serve as yet another way to scare people.”
On Sunday, Saffron Cordery, deputy chief executive of NHS Providers, told Sky News that the Pfizer/BioNTech vaccine authorization and approval process “has been incredibly robust.
“Usually, the US Centers for Disease Control and Prevention recommends informing a provider before taking any vaccine if you have any severe, life-threatening allergies.”
Allergies are also a consideration for other not yet approved Covid-19 vaccines.
One volunteer in the high-dose community had a serious allergic reaction within 48 hours of the first dose during the Chinese company Sinovac’s Phase 2 trial, which researchers said could be linked to the vaccine. The volunteer was treated for the reaction and within three days he recovered. A similar allergic reaction to the second shot was not encountered by the same volunteer.
