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

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Britain’s medical regulator today revealed it has not yet spotted any link between Pfizer and Moderna’s vaccines and heart damage after US officials called an urgent meeting to discuss inflammation that could be cause by the vaccines.

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.

But 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. 

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. 

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.

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. 

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.