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health warnings Nine cases of heart condition detected following Pfizer or Moderna vaccine

Health officials say it is a ‘very rare condition’

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Henry Street during the Covid-19 pandemic in Dublin’s city centre. Photo: Collins/Gareth Chaney

Henry Street during the Covid-19 pandemic in Dublin’s city centre. Photo: Collins/Gareth Chaney

Chief Medical Officer Tony Holohan

Chief Medical Officer Tony Holohan

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Henry Street during the Covid-19 pandemic in Dublin’s city centre. Photo: Collins/Gareth Chaney

Ireland’s medicines’ watchdog has been notified of nine cases of a heart condition after people were given the Pfizer or Moderna Covid-19 vaccine.

The Health Products Regulatory Authority (HPRA) said the very rare condition happened after the first dose in six cases and three following a second dose.

Some two million of these Covid-19 vaccines were administered at that point on June 9.

“In a number of reports there were possible alternative explanations, other than vaccinations,” a spokesperson said.

The inflammatory conditions are known as myocarditis and pericarditis and they can cause chest pain, a fever, a fast heartbeat, tiredness and shortness of breath.

The European Medicines Agency (EMA) said yesterday myocarditis and pericarditis must be listed as side-effects of the two vaccines, and cases mostly occurred within 14 days of inoculation.

It said cases occurred more often after the second dose and in younger adult men.

Symptoms from the conditions include breathlessness, palpitations and chest pain.

The EMA said it was continuously monitoring the safety of approved vaccines as they were rolled out more widely.

It stressed that the “benefits of all authorised Covid-19 vaccines continue to outweigh their risk.”

The HPRA said four cases here occurred in women and five in men.

The median age was 56 years – ranging from 38 to 81.

“In most cases the individuals were reported to have recovered and were recovering with ongoing symptoms in some.”

The EMA’s safety committee looked at 164 cases of myocarditis and 157 of pericarditis among those who received Pfizer or Moderna vaccines and, as of May 31, some 200 million doses of these jabs were given in Europe.

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The HPRA said the benefits of the vaccines outweigh the risks but for very rare serious side effects there needs to be monitoring of signs and symptoms.

A spokeswoman for Pfizer said the the EMA’s safety committee has recommended updating the product information for the vaccine to include listing myocarditis and pericarditis as new side effects, together with a warning to raise awareness among healthcare professionals and people taking these vaccines.

“Very rare cases of myocarditis and pericarditis have been reported following vaccination with Comirnaty. These cases occurred predominantly in adolescents and young adults, more often in males than females, more often after the second dose of the vaccine, and typically within 14 days after vaccination.

“These are generally mild cases and individuals tend to recover within a short time following standard treatment and rest.

"Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis in vaccine recipients.

“EMA continues to recommend Covid-19 vaccinations for individuals aged 12 and older.

"With hundreds of millions of doses of the Pfizer-BioNTech Covid-19 vaccine administered globally, the benefit risk profile of our vaccine remains positive for all approved indications and age groups.”

It comes as Ireland’s Covid-19 vaccine roll-out remains a key weapon in reducing the impact of the Delta variant wave.

However, the Department of Health was unable to say yesterday how many Covid-19 vaccines were due here before the end of August, despite the rising threat.

A spokesperson for its press office was unavailable.

It comes as 631 new cases of the virus were reported yesterday, the highest since April.

The number of patients with Covid-19 in hospital fell to 50, down from 58 the previous day. There were 15 in intensive care.

Chief medical officer Dr Tony Holohan said the rise in cases was a cause of concern and shows the disease “is prevalent in communities again.

“We know there is worry and frustration out there, particularly for young people who have had significant parts of their lives put on hold by this disease.

“We ask if you are not vaccinated to hold firm to public health advice as you await your vaccine.”

They should manage their contacts, meet outdoors and avoid crowds, he said.

People who feel they have symptoms should seek a free Covid-19 test and this also applies to close contacts who might have been exposed to infection, he added.

Some hospitals are already seeing winter levels of attendances at emergency departments and will come under increasing pressure as Covid hospitalisations rise.

Around one in five patients with Covid are in Letterkenny Hospital in Donegal where there is a high incidence.

As of Wednesday it had ten of these patients.

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