THE country has started a landmark vaccination programme with those most at risk of coronavirus starting immunisations this week.
But when it emerged that two people with allergies fell ill after having the jab on V-Day, it left many wondering whether they will be vaccinated.
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The UK medicines regulator changed its Covid vaccine guidance after two people suffered allergic reactions[/caption]
The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on Wednesday following the rare reactions.
It now says that those with a history of life-threatening allergies to a vaccine, medicine or food should not get the Pfizer Covid-19 jab.
The regulator has not specified every individual allergy but stated: “Any person with a history of immediate-onset anaphylaxis to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine.”
It added: “A second dose of the Pfizer/BioNTech vaccine should not be given to those who have experienced anaphylaxis to the first dose.”
June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said anaphylaxis was a “known … very rare side effect with any vaccine”.
Around 10 per cent of the UK population has a penicillin allergy documented in their clinical notes.
However, only around five per cent of these people have a true penicillin allergy, according to research published in the British Medical Journal in 2018.
The NHS says that in most cases, the allergic reaction is mild to moderate and can take the form of an itchy rash, coughing, wheezing and breathing difficulties.
These mild to moderate allergic reactions can usually be successfully treated by taking antihistamines.
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
- Muscle pain
- Joint pain
Common (Likely to affect up to one in ten people)
- Injection site swelling
- Redness at injection site
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
But in rare cases it can cause a severe and potentially life-threatening allergic reaction known as anaphylaxis.
The National Institute for Health and Care Excellence (NICE) has previously warned that some people who were diagnosed with a penicillin allergy as a child may have grown out of it without knowing.
It can put people at risk of drug-resistant superbugs – so it is important that people with a penicillin allergy are properly diagnosed, the body warned.
Prof Gillian Leng, deputy chief executive of NICE said: “Lots of people think they are allergic to penicillin because it gave them a rash when they were a child, their mum or dad told them they were allergic and it has stayed in their notes for decades.
“That is a very different thing to having a true penicillin allergy, which can result in a life-threatening anaphylactic reaction.”
The Sun Online has contacted the MHRA for clarification on whether those with penicillin allergies are excluded from having the Covid jab.
Guidance for the vaccine was altered after two NHS staff members who received the jab on Tuesday had allergic reactions.
The health workers, who are understood to both have a history of severe allergic reactions, were among thousands to receive the vaccine on the first day of the Covid-19 mass vaccination programme.
A further report of a possible allergic reaction following immunisation was also received by the MHRA.
Dr Raine said a group including experts on allergy and clinical immunology was convened on Wednesday to consider any possible mitigation to the “rare risk of anaphylaxis”.
“Anaphylaxis is a known, although very rare, side effect with any vaccine,” she said.
“Most people will not get anaphylaxis and the benefits in protecting people against Covid-19 outweigh the risks.”
Pfizer said the vaccine was “well tolerated” during the trials with “no serious safety concerns”.
Dr Raine added: “You can be completely confident that this vaccine has met the MHRA’s robust standards of safety, quality and effectiveness.
“The safety data has also been critically assessed by the government’s independent advisory body, the Commission on Human Medicines. No vaccine would be approved unless it meets these stringent standards – on that you can be sure.”
‘PUT IN PERSPECTIVE’
Peter Openshaw, past-president of the British Society for Immunology and 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.
“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 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).
“Similar to the rollout of all new vaccines and medications, this new Covid-19 vaccine is being monitored closely by the MHRA.
“They will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental.
“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.”
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Pregnant women, those planning a pregnancy and breastfeeding mums have also been advised not to get the jab.
Children under the age of 16 are also exempt from vaccinations, health officials said.
This is because none of these groups were included in clinical trials and there’s not enough data to know whether it’s safe to give them the jab.