PEOPLE with "significant allergies" have been warned not to get Pfizer's Covid-19 vaccine after two NHS workers fell ill on V-Day.
The healthcare workers developed symptoms shortly after having the jab on the first day of the UK's mass vaccination programme, officials said.
They both have a significant history of allergic reactions - to the extent where they need to carry an adrenaline pen with them, NHS England said.
Officials confirmed the staff members - who were among thousands to get the jab yesterday - are now recovering and all trusts involved in the vaccination programme have been informed.
The Medicines and Healthcare products Regulatory Agency (MHRA) has given precautionary advice that anyone who has a history of "significant" allergic reactions to medicines, food or vaccines should not receive the vaccine.
"Significant" means a person has suffered anaphylaxis - a potentially life-threatening reaction which can cause breathing difficulties, confusion, vomiting or collapse - or needs to carry an EpiPen.
Anyone scheduled to receive the vaccine on Wednesday will be asked about their history of allergic reactions.
RULED OUT
The MHRA advice states: "Any person with a history of 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.
"Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available."
Professor Stephen Powis, national medical director for the NHS in England, said: "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.
"Both are recovering well."
The news will come as a huge blow to people with allergies.
What is a common vaccine reaction?
According to the NHS, the most common side effects of vaccination are:
- the area where the needle goes in looking red, swollen and feeling a bit sore for 2 to 3 days
- babies or young children feeling a bit unwell or developing a high temperature for 1 or 2 days
It's "rare" for anyone to have a serious allergic reaction to a vaccination, the NHS says.
If this does happen, it usually happens within minutes.
The person who vaccinates you or your child will be trained to deal with allergic reactions and treat them immediately. With prompt treatment, you will make a good recovery.
The Pfizer/BioNTech jab showed the following side effects in trials:
Like all vaccines, the new coronavirus vaccine can cause side effects, although not everybody gets them.
Very common (Likely to affect more than one in ten people)
- Pain at injection site
- Tiredness
- Muscle pain
- Chills
- Joint pain
- Fever
Common (Likely to affect up to one in ten people)
- Injection site swelling
- Redness at injection site
- Nausea
Uncommon (May affect one in 100 people)
- Enlarged lymph nodes
- Feeling unwell
The NHS says all vaccines are thoroughly tested to make sure they will not harm you or your child.
It often takes many years for a vaccine to make it through the trials and tests it needs to pass for approval.
But scientists have been working at speed to develop a Covid jab in under one year.
This has been possible because of huge funding, global collaboration, and because there was high transmission of the virus globally to test it.
Experts have said "no corners have been cut" in testing Covid vaccines.
Once a vaccine is being used in the UK it's also monitored for any rare side effects by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA accounced on December 2 the Pfizer/BioNTech was safe and effective.
An estimated 10 to 40 per cent of the population have an allergy, according to Allergy UK - however most of these will not be severe.
More than 200,000 people in the UK, including children, have severe allergies that require them to carry an EpiPen, according to the National Institute of Health and Clinical Excellence.
Some of the most common allergies, according to the NHS, are to foods like nuts, fruit, shellfish, eggs and cow's milk, and medicines - such as ibuprofen, and antibiotics, such as penicillin.
The two NHS staff members were among thousands of Brits who became the first people in the world to receive the Pfizer vaccine yesterday.
Elderly British patients who were first in line to get the jab urged sceptics to take the vaccine for the good of the country.
The MHRA added should anyone else given the jab suffer any suspected adverse reactions to report it via the Yellow Card scheme.
Dr June Raine, chief executive of the MHRA, said today the cases were being investigated after regulators were told of the reactions on Tuesday night.
She added: "I may share with the committees that even last evening, we were looking at two case reports of allergic reactions.
"We know from the very extensive clinical trials that this wasn't a feature."
'WELL TOLERATED'
Pfizer said today the vaccine was "well tolerated" during the trials with "no serious safety concerns".
A spokeswoman for Pfizer said: "We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the Covid-19 BNT162b2 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."
Pfizer said the trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination.
According to Pfizer’s clinical trial protocol, people were not enrolled in the trial if they had a “history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)”.
It is not clear if people with severe allergies related to medicines or food were included.
Professor Peter Openshaw, past-President of the British Society for Immunology and Professor of Experimental Medicine at Imperial College London, said allergic reactions were monitored in the trial participants.
Referring to an analysis by the FDA published on Tuesday, he said: "The occurrence of any allergic reaction was one of the factors monitored in the phase 3 clinical trial of this Pfizer/BioNTech Covid-19 vaccine, the detailed data from which was released yesterday.
"In this, they reported a very small number of allergic reactions in both the vaccine and placebo groups (0.63 per cent and 0.51 per cent)."
Paul Hunter, a professor in medicine at University of East Anglia, told The Sun: "Allergic reactions to vaccines do occur and are immunizations are often contraindicated in for people who have had a previous severe reaction.
"This is why people who have had the vaccine are required to hang around for a while after having had their injection. If you are still in the clinic an allergic reaction is much easier to deal with.
"I don’t think this is particularly unexpected and I do not think it should interfere with roll out of the vaccination programme."
Dr Andrew Preston, a reader in microbial pathogenesis, Department of Biology and Biochemistry at University of Bath, told The Sun: "Allergic reactions arise from a trigger of an aspect of the immune system by a specific stimulus.
"So it will be a case of working out what the signal is from within the vaccine.
"There is an obligation to not knowingly risk the health of trial participants, so often they will exclude groups for which there might be a predicated risk.
"For example, people with major immunocompromisation would be excluded from trials of live vaccines.
"But the bottom line is in these initial trials of tens of thousands of people, you can’t include every possible set of conditions.
"That’s why no matter how thorough a trial is, there will always be some-people who have a reaction.
"Obviously if this starts to become a significant number then you have to start to consider the cost-benefit at the population level."
Professor Openshaw said there is a "very small chance" of an allergic reaction to a vaccine with all food and medication allergies.
"However, it is important that we put this risk in perspective," 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.”
MONITORING SIDE-EFFECTS
The vaccine uses mRNA technology which has never been approved for use before.
However, it has been around for years and tested in humans for at least four infectious diseases: rabies, influenza, cytomegalovirus, and Zika.
Dr Raine told the Commons Science and Technology Committee today that careful plans had been made for “real-time vigilance” when monitoring side effects from vaccinations.
Any updates to advice for patients would be communicated “immediately”.
She said: “The role is before, during and after, and there is a true end-to-end looking from the scientific laboratory bench through to the patient who yesterday first received the vaccine.
“As an illustration to this, I may share with the committee that even last evening we were looking at two case reports of allergic reaction.
“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice now that we have had this experience in the vulnerable populations … we will get that advice to the field immediately.”
Professor Chris Whitty, chief medical officer for England, said the NHS and the Medicines and Healthcare products Regulatory Agency (MHRA) are in a “very good position” to pick up issues with any vaccine.
“Dr (June) Raine talked about identifying things once a vaccine is in use,” he told the Commons Science and Technology and Health and Social Care committees.
“The initial process, very importantly, picks up common side effects, that’s what the big phase two and then subsequently, if they are safe, phase three clinical trials allow to happen.
“But extremely rare but important issues, inevitably you accrue more information over time.
“The NHS through to the MHRA is in a very good position to make sure that we can pick things up quickly, identifying them, communicate them widely, ensure that we improve practice.”
LANDMARK DAY
Yesterday was dubbed V-Day as the first people in the world were given the Covid vaccine in a massive step towards demolishing the disease.
Margaret Keenan, 90, was given the first jab in Coventry just after 6.30am marking the start of a phased NHS rollout of the vaccine to older people, health staff and care home workers.
GPs are now due to start booking Covid vaccine appointments within days with the UK readying itself for the arrival one million more jabs.
Two more consignments of the vaccine will be delivered both next week and the following week - on top of the initial 800,000 doses.
This means the NHS should now have four million doses of the jab before Christmas.
Boris Johnson said people objecting to having the jab are “totally wrong” to do so, amid fears anti-vaxxing campaigns will deter people from accepting an offer to receive the vaccine.
Speaking at the vaccination centre at Guy’s Hospital in London on Tuesday, the PM said it was moving to talk to Lyn Wheeler, 81, who was the first to receive the vaccine there.
The PM said: “To all those who are scared (of getting vaccinated) – don’t be. You have seen Lyn (Wheeler) take it, you have seen people take the vaccine this morning in large numbers.
“There’s nothing to be nervous about.”
He added: “What I would say is that there are those obviously who feel that a vaccine is something they object to politically or for ideological reasons.
“I think they are totally wrong. It’s safe, it’s the right thing to do, it’s good for you and it’s good for the whole country."
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