UK regulators admit ‘very rare’ link between heart inflammation and Covid vaccines after cases rise
UK regulators have admitted there could be a link between "very rare" heart inflammation and Covid vaccines.
After investigating less than 100 cases in the UK, the MHRA concluded the Pfizer and Moderna Covid vaccines could be the cause.
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The conditions reported are myocarditis, which causes inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart.
Young men are most affected, particularly after a second dose, research shows.
The MHRA said anyone who experiences "chest pain, shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart" after a jab should seek urgent medical attention.
Dr June Raine, MHRA Chief Executive, today said: “We have carefully reviewed reports of suspected adverse reactions involving types of heart inflammation known as myocarditis and pericarditis...
"We have concluded that the COVID-19 vaccines made by Pfizer/BioNTech and Moderna may be linked with a small increase in the risk of these very rare conditions.
"The cases tended to be mild and the vast majority recovered with simple treatment and rest."
It comes after the MHRA had previously said it did not see higher than expected cases amid growing concern in the US.
Now the MHRA said a decision to update the Product Information for the two jabs and the newly found side effect has been endorsed by experts.
Dr Raine continued: “No medicine is without risk, and in this case the risk appears to be small. We will continue to monitor this issue closely.
“The benefit risk balance for the Pfizer/BioNTech and for the Moderna vaccine remain favourable.
"It is still vitally important that people come forward for their first and second vaccination when invited to do so, unless advised otherwise.
“Over 75 million doses of COVID-19 vaccines have been administered in the UK, saving thousands of lives, and our advice remains that the benefits of getting vaccinated outweigh the risks in the majority of people."
In its latest report of side effects to June 16, it said there have been 88 cases of heart conditions among 27.7 million Pfizer shots - a risk of three in a million.
There have been three cases after 73,000 Moderna shots, equivalent to around 41 in a million.
There have also been 119 among 44.1 million Oxford/Astrazeneca vaccine shots, or 2.7 in a million.
But the MHRA said: “The available evidence for the COVID-19 Vaccine AstraZeneca does not suggest an increased risk of myocarditis or pericarditis."
The MHRA said it is “closely monitoring cases” and urged people to get their second doses when invited.
US officials have put the risk of the complication at 12 in a million.
New studies back link
It comes as two new studies, published in JAMA Cardiology, have provided more evidence of the serious, but extremely rare, side effect.
found 23 cases of heart inflammation in the US military after they had shots made by either Pfizer or Moderna - which use the same vaccine technology called mRNA.
The US military has given more than 2.8 million doses of vaccines, meaning if the side effect is proven, it is rarer than one in 100,000.
Nineteen of the men had been given their second shot.
The number of cases were higher than what would have been expected - a predicted eight or fewer cases from the 436,000 male military members who received two shots.
investigated four cases of heart inflammation after a second dose of a Pfizer of Moderna jab.
All had been hospitalised suffering chest pain - a typical sign of the condition. But they were discharged without any long-lasting problems.
The researchers wrote in their paper: “It is possible that these four cases of acute myocarditis represent a rare, potential adverse event linked to mRNA COVID-19 vaccination.
“The findings from the present report raise the possibility of an association between mRNA COVID-19 vaccination and acute myocarditis.”
What are the symptoms to look out for?
Both myocarditis and pericarditis are usually caused by a viral infection, bacteria, parasite or fungi.
Covid itself can lead to heart inflammation, doctors say, sometimes lasting several months as a symptom of long Covid.
But in the JAMA study of four patients with the conditions after a jab, researchers said there was no evidence they had previously suffered Covid.
The main symptoms to look out for, according to the British Heart Foundation and the Mayo Clinic, are:
- a stabbing pain and/or tightness in the chest which may spread across the body (myocarditis and pericarditis)
- flu-like symptoms such as a high temperature, tiredness and fatigue (myocarditis and pericarditis)
- fluid retention with swelling of your legs, ankles and feet (myocarditis and pericarditis)
- shortness of breath when lightly exercising or walking (myocarditis)
- difficulty breathing when resting (myocarditis)
- palpitations or an abnormal heart rhythm (myocarditis)
- a sudden shortness of breath - if you experience this get urgent medical help (pericarditis)
- pain in the neck that may spread across the shoulders and/or arms (pericarditis)
- nausea or feeling light headed (pericarditis)
The MHRA said anyone who experiences "chest pain, shortness of breath or feelings of having a fast-beating, fluttering, or pounding heart" after a jab should seek urgent medical attention.
Dr Matthew Oster, from the CDC's COVID-19 Vaccine Task Force, said: "mRNA vaccines may be a new trigger for myocarditis, yet it does have some different characteristics.”
Difficulty sleeping may be more common, according to the .
GROWING EVIDENCE
Growing evidence over the past few months has shown cases of heart inflammation after a jab are higher among younger men.
The US Centers for Disease Control and Prevention (CDC) said most cases have occurred in “male adolescents and young adults aged 16 years or older”.
Patients have usually been given their second dose and get symptoms several days later.
But the CDC has reminded the public a vaccine is the best way to prevent Covid and the benefits outweigh any potential risks.
And even though cases are mostly in younger people, and children in the US are able to get jabs, researchers fear they are more likely to catch Covid than suffer this rare side effect.
After an emergency meeting, a panel of experts who advise the CDC agreed on June 23 there was a “likely association” between the jabs and rare heart conditions.
Dr Matthew Oster, from the CDC's COVID-19 Vaccine Task Force, said: "mRNA vaccines may be a new trigger for myocarditis, yet it does have some different characteristics.”
Difficulty sleeping may be more common, according to the .
Dr Tom Shimabukuro, deputy director of the Immunization Safety Office at the CDC, said there had been 1,226 cases of myocarditis after mRNA vaccines, according to .
It’s approximately 12.6 heart inflammation cases per million doses given in the US, based on roughly 300 million shots administered as of June 11, the CDC said.
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But the cases were more frequent among Moderna’s vaccine recipients at 19.8 cases per million versus eight cases per million for Pfizer’s.
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“This is still a rare event,” Dr Shimabukuro said at the meeting.
The first reports of myocarditis and pericarditis occurred in Israel in January.