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UK REGULATORS HAVE issued a warning that people who have a history of “significant” allergic reactions should not currently receive the Pfizer / BioNTech Covid-19 vaccine after two people who received the injection yesterday had allergic reactions.
Two NHS staff members who received the vaccine on the first day of the mass vaccination program suffered an allergic reaction, the NHS England confirmed.
Both are understood to have a significant history of allergic reactions, insofar as they need to carry an adrenaline auto-injector.
They were among the thousands of people who received the vaccine yesterday.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has given cautionary advice to the NHS trusts that anyone who has a history of “significant” allergic reactions to drugs, foods or vaccines should not receive the vaccine.
The NHS in England said that all trusts involved with the vaccination program have been informed.
This means that anyone scheduled to receive the vaccine today will be asked about their history of allergic reactions.
The Irish government has said that the launch of the vaccine could begin in the Republic next month, once the European Medicines Agency (EMA) gives its approval.
The EMA is set to complete a review of the Pfizer / BioNtech vaccine on December 29 and a decision on the Moderna vaccine could also come a couple of weeks later.
The government has signed up to six vaccine advance purchase agreements from Moderna, AstraZeneca, Jansen, Sanofi, CureVac and Pfizer.
‘Well tolerated’
Professor Stephen Powis, National Medical Director of the NHS in England, said: “As is common with new vaccines, the MHRA has advised as a precaution that people with a significant history of allergic reactions should not receive this vaccine after two people with a The history of major allergic reactions responded negatively yesterday.
“They are both recovering well.”
The MHRA advice states: “Anyone with a history of a significant allergic reaction to a vaccine, drug, or food (such as a prior history of anaphylactoid reaction or those who have been recommended to carry an adrenaline autoinjector) should not receive / BioNtech vaccine.
“Resuscitation facilities must be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available. “
The two NHS workers developed symptoms of “anaphylactoid reaction” shortly after receiving the vaccine, but both recovered after appropriate treatment.
Pfizer said the vaccine was “well tolerated” during the trials without “serious safety concerns.”
A spokeswoman said: “The MHRA has informed us of two reports of yellow cards that may be associated with an allergic reaction due to the administration of the Covid-19 BNT162b2 vaccine.
“As a precautionary measure, the MHRA has issued temporary guidance to the NHS while conducting an investigation in order to fully understand each case and its causes.
“Pfizer and BioNTech are supporting the MHRA in the investigation.
“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 trial has enrolled more than 44,000 participants to date, more than 42,000 of whom have received a second vaccine.”
The yellow card scheme is the UK’s system for collecting and monitoring information on suspected safety issues or incidents related to drugs and medical devices.
Commenting on the development, Peter Openshaw, former president of the British Society for Immunology and professor of experimental medicine at Imperial College London, said: “As with all foods and medicines, there is a very small chance of an allergic reaction to any vaccine.
“However, it is important that we put this risk in perspective. The occurrence of any allergic reaction was one of the factors monitored in the phase three clinical trial of this Pfizer / BioNTech Covid-19 vaccine, the detailed data of which was published yesterday.
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“In this, they reported a very small number of allergic reactions in both the vaccine and placebo groups (0.63% and 0.51%).
“Similar to the launch of all new vaccines and drugs, this new Covid-19 vaccine is being closely monitored by the MHRA.
“Now they will investigate these cases in more detail to understand if the allergic reactions were related to the vaccine or were incidental.
“The fact that we know about these two allergic reactions so soon and that the regulator has acted on them to issue precautionary advice shows that this monitoring system is working well.”
The vaccine patient safety leaflet advises that anyone allergic to any of the active ingredients in the vaccine should not receive the injection.
He adds: “Signs of an allergic reaction can include an itchy rash, shortness of breath and swelling of the face or tongue.”
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