UK regulators yet to see myocarditis link to Pfizer’s Covid jab

Britain’s medical regulator today revealed it has not yet detected any link between Pfizer and Moderna’s Covid vaccines and heart damage, despite US officials calling an urgent meeting over growing fears there is a connection.

The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs in the UK, said it is ‘closely monitoring reports of myocarditis and pericarditis received with the Covid vaccines’. 

It has recorded just 34 cases of myocarditis after Pfizer jabs — a similar number to after the AstraZeneca vaccine — and only two after Moderna, but says numbers ‘similar or below expected background levels’.

Meanwhile the US’s version of the MHRA, the Centers for Disease Control (CDC), has announced  officials will gather on June 18 to discuss 226 plausible cases of heart inflammation in under-30s given the jabs in America. 

Officials yesterday admitted the number of cases was higher than expected and that most were in boys and young men. However, they insisted the complication was still rare. 

All the cases met the CDC’s ‘working case definition’ of myocarditis and pericarditis but the actual number of reports made stands at almost 800. Hundreds of affected patients are still being reviewed.

Among the cases spotted in the US, three are in intensive care, 15 are hospitalised and 41 have ongoing symptoms. 

The CDC continues to urge everyone aged 12 and older in the US to get vaccinated and says it is not clear if either condition is actually caused by the shots.

However, similar links were also uncovered in Israel, Canada, and the Pfizer vaccine was yesterday rejected for all children aged 12 to 17 in Germany who do not have underlying health conditions. 

No10 has not yet expanded the inoculation drive to under-18s, despite officials approving Pfizer’s jab for teenagers. It means there are destined to be fewer cases spotted in Britain currently, if the condition is proven to occur more often in younger adults.

The average age for people suffering the condition in the US was 24 — who have yet to begin routinely receiving their jabs in Britain — and comparatively few Moderna doses have been dished out in the UK.

Last night it also emerged supplies of Pfizer’s jab to the UK will be tight throughout June. More than 25million doses have already been dished out. 

US health officials Thursday announced they are investigating what appear to be higher than expected reports of heart inflammation in male teens and young adults after getting their second doses of the two vaccines

US health officials Thursday announced they are investigating what appear to be higher than expected reports of heart inflammation in male teens and young adults after getting their second doses of the two vaccines

US health officials Thursday announced they are investigating what appear to be higher than expected reports of heart inflammation in male teens and young adults after getting their second doses of the two vaccines 

The Centers for Disease Control and Prevention (CDC) has called an 'emergency meeting' over 226 cases of heart inflammation in people who have had either the Pfizer or Moderna Covid vaccines. Pictured: A girl receives her vaccine in Harrow, London

The Centers for Disease Control and Prevention (CDC) has called an 'emergency meeting' over 226 cases of heart inflammation in people who have had either the Pfizer or Moderna Covid vaccines. Pictured: A girl receives her vaccine in Harrow, London

The Centers for Disease Control and Prevention (CDC) has called an ’emergency meeting’ over 226 cases of heart inflammation in people who have had either the Pfizer or Moderna Covid vaccines. Pictured: A girl receives her vaccine in Harrow, London

The MHRA has received 34 reports of myocarditis and 26 reports of pericarditis in the UK following a Pfizer vaccine.

It has seen similar levels after AstraZeneca — 31 of myocarditis and 51 of pericarditis — and only two after Moderna.

UK faces shortage of Pfizer vaccines throughout June

Vaccines minister Nadhim Zahawi today admitted that supply of the Pfizer vaccine will be tight over the next few weeks but insisted that it was ‘stable’.

It comes after Scotland’s Health Secretary Humza Yousaf warned supply of the Pfizer vaccine will be ‘particularly tight’ over the next few weeks.

Mr Zahawi told LBC: ‘I am absolutely confident, and I’ll speak to Humza on this, that we will be able to deliver the Pfizer vaccines that Scotland needs to be able to meet its targets for end of July, as the United Kingdom target.’

Asked if it is going to be ‘tight’ in the next few weeks, he said: ‘It will be, there is no doubt. Every time I’ve come on your show I’ve said that the determining factor in terms of vaccine in arms is supply.

‘And supply remains finite, but it is stable, and Pfizer have done a great job in being consistent on their delivery schedule.’

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Of the 14.7million people to have had a Pfizer jab, 0.0004 per cent have suffered either myocarditis or pericarditis. The rate was slightly lower in AstraZeneca recipients: 0.0003 per cent of the 24.5million people to have had a first dose.

The regulator said: ‘The number of reports of myocarditis and pericarditis reported with the vaccines in the UK remains similar or below the expected background rate in different age groups within the general population and does not currently indicate an increased risk following vaccination against Covid. 

‘We will continue to closely monitor these events reported in the UK and internationally.’ 

Both types of heart inflammation can be caused by a variety of infections, including a bout of Covid, as well as certain medications.

There have been rare reports following other types of vaccinations in the past. 

More than 130million Americans have received both their first and second doses of the Pfizer and Moderna vaccines. 

This means just 0.0002 per cent of fully-vaccinated Americans have reported the complication. 

Cases are reported through the US Vaccine Adverse Event Reporting System (VAERS).

The system accepts reports from everyone, regardless of the plausibility of the vaccine causing the symptom.

In total, VAERS received 216 cases of heart inflammation after the first dose of an mRNA shot, and another 573 cases after the second dose. 

A total of 488 reports were from people who had the Pfizer vaccine, while the remaining 301 had Moderna. 

More than half of the cases reported after people had received their second dose were in people between the ages of 12 and 24, the CDC said.  

This group accounts for less than nine per cent of doses administered. Almost two-fifths of cases were in males. 

A total of 226 cases have been reported that may meet the CDC's 'working case definition' of myocarditis and pericarditis following the shots, the agency said. Among the 226, three are in intensive care, 15 are hospitalised, and 41 have ongoing symptoms. The rest have recovered

A total of 226 cases have been reported that may meet the CDC's 'working case definition' of myocarditis and pericarditis following the shots, the agency said. Among the 226, three are in intensive care, 15 are hospitalised, and 41 have ongoing symptoms. The rest have recovered

A total of 226 cases have been reported that may meet the CDC’s ‘working case definition’ of myocarditis and pericarditis following the shots, the agency said. Among the 226, three are in intensive care, 15 are hospitalised, and 41 have ongoing symptoms. The rest have recovered

What is myocarditis? 

Myocarditis is an inflammation of the heart muscle. There are no specific causes of the condition but it is usually triggered by a virus.

Some of the most common infections which cause myocarditis, are those called adenovirus and Coxsackie B.

It can be caused by the common cold, hepatitis B and C, and herpes simplex virus. 

The most common symptoms of the condition include chest pain, a fever, a fast heartbeat, tiredness and shortness of breath.

If the inflammation damages the heart muscle or the fibres that conduct electrical pulses to the heart, complications can develop.

They can develop quickly, and include sudden loss of consciousness, an abnormally fast, slow or irregular heartbeat.

In very severe cases the condition is fatal, causing heart failure or sudden death. The inflammation enlarges the heart and creates scar tissue, forcing it to work harder and therefore making it weaker.

In most cases of viral myocarditis, the illness goes away and there are no complications. 

But in rare cases when inflammation is severe, there can be damage to the heart which needs monitoring and possibly a heart transplant.

Myocarditis can reoccur, but there is no known way to prevent this. The risk of recurrence is low, around 10 to 15 per cent, according to Myocarditis Foundation.

It is difficult to gauge the prevalence of myocarditis because there is no widely available test for it.

In 2010, approximately 400,000 people died of heart muscle disease – cardiomyopathy that includes myocarditis – worldwide.

Expert consensus opinion estimates that up to 40 per cent of dilated cardiomyopathy results from myocarditis, according to the National Organisation for Rare Disorders.

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The overwhelming majority of the cases have occurred within a week of vaccination. 

Symptoms included chest pain and breathing difficulties. 

The CDC’s vaccine advisory committee will meet on June 18 to further evaluate the possible risk.       

Dr Tom Shimabukuro told a government vaccine meeting about the investigation Thursday.

He said: ‘It’s a bit of an apples-to-oranges comparison because, again, these are preliminary reports.’

‘Not all these will turn out to be true myocarditis or pericarditis reports.’  

Dr Shimabukuro said the CDC findings were mostly ‘consistent’ with the findings of Israel’s Health Ministry, which first reported a likely link to the Pfizer vaccine and the condition in young men. 

Doctors were first alerted to the possible link between myocarditis and vaccines back in May, amid reports of cases in young males. 

The CDC urged providers to ask patients with symptoms of heart inflammation if they had taken the Covid vaccine. 

Earlier this month, it was reported that seven teen boys in the US had suffered heart inflammation after their second Pfizer shots.  

The study found the boys, aged between the ages of 14 and 19, developed chest pain within a few days of having the second jab. 

Heart imaging tests showed myocarditis.

None were critically ill, and all were healthy enough to be sent home after two to six days in the hospital.  

Around the same time, the Department of Defense began to track 14 cases. 

Israel claimed in early June that its research showed Pfizer’s vaccine is the ‘probable’ cause of heart inflammation in a very small number of people who get the jab.

The Health Ministry had found 148 cases of myocarditis soon after the patient had been vaccinated. 

In total, 275 cases were spotted among the more than five million people given the Pfizer jab in Israel, which has had one of the world’s most successful jab rollouts. 

In the remaining 127 cases, it is unclear if they are linked to the vaccine.

This was equivalent to just 0.005 per cent of recipients, or one in 20,000 people. 

For the 148 cases ‘probably’ linked to the jab, the rate was 0.003 per cent — although half of them had other underlying health problems. 

Israel was one of the first to warn of health concerns linked to the Pfizer vaccine. 

In May, officials at the European Medicines Agency also reported receiving 107 reports of myocarditis following the Pfizer vaccine.   

Pfizer was granted emergency use authorisation for children aged 12 and over last month in the US. It is now working on trials with children as young as six months old. 

Moderna is still only available for adults in the country. 

Meanwhile, the AstraZeneca and Johnson & Johnson vaccines have also both been investigated for possible — extremely rare — ties to blood clots. 

The MHRA last week approved the Pfizer vaccine for 12- to 15-year-olds in the UK but there are no plans to expand the roll-out to under-18s yet.

Pfizer’s supply shortage to the UK comes as a blow, making the prospect of speeding up the vaccine roll-out to meet demand much more difficult. 

MSP Humza Yousaf told Matt Hancock in a letter that supplies of the jab are to be ‘particularly tight over the next few weeks’, not just in Scotland but across the UK, according to the i newspaper. 

Mr Yousaf’s fears are the result of the updated advice published the Joint Committee on Vaccination and Immunisation last month, which said that under-40s should be given Pfizer or Moderna jabs rather than the AstraZeneca equivalent due to concerns over a small risk of blood clots in younger patients.

And with thousands of under-30s now receiving jabs after the vaccine roll-out picked up pace, demand for doses of Pfizer has now soared beyond supply levels.

Where else have myocarditis and pericarditis been linked to Covid vaccines or Pfizer been banned for teenagers?

Israel

Israel was one of the first to warn of health concerns linked to the Pfizer vaccine. 

The country claimed in early June that its research showed Pfizer’s vaccine is the ‘probable’ cause of heart inflammation in a very small number of people who get the jab.

The Health Ministry had found 148 cases of myocarditis soon after the patient had been vaccinated. 

In total, 275 cases were spotted among the more than five million people given the Pfizer jab in Israel, which has had one of the world’s most successful jab rollouts. 

In the remaining 127 cases, it is unclear if they are linked to the vaccine.

This was equivalent to just 0.005 per cent of recipients, or one in 20,000 people. 

For the 148 cases ‘probably’ linked to the jab, the rate was 0.003 per cent — although half of them had other underlying health problems.  

Canada

At least one health official in Canada has also linked the Pfizer vaccine to heart inflammation.

Dr Peter Liu, chief scientific officer at the University of Ottawa Heart Institute and an expert in myocarditis, last week said he has seen two cases he believes are linked to vaccination over the last month. 

He told the Ottawa Citizen: ‘One can never be sure, but it is more than coincidental.

‘We are learning more about this every day.’ 

Germany

The European Medicines Agency confirmed in May it was looking into cases of myocarditis and pericarditis in people who had received either the Moderna or Pfizer vaccine.

It said: ‘There is no indication at the moment that these cases are due to the vaccine.’

Germany’s vaccine advisory committee, known as STIKO, yesterday recommended only children and adolescents with pre-existing conditions should be given the Pfizer vaccine.

STIKO said it recommends a vaccination only for those youngsters with an illness that raises their risk of a serious case of coronavirus.

It said it was not currently recommending the use of the vaccine for those aged 12 to 17 without pre-existing conditions, although noted doctors were allowed to give the shot if the individual accepts the risk.

Germany has said it plans to offer shots to children as young as 12 from June after the European health regulator authorised the vaccine for use in adolescents last month.

STIKO committee member Ruediger von Kriess, a paediatrics professor, said previously it might be preferable to endorse the vaccine for use in children only if they have risk factors given the lack of data on long-term effects.

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