Benefits of Covid-19 vaccines outweigh the risks, latest figures show

Some reports of suspected side effects relate to heart issues, regulatory authority says

06/01/2021 - NEWS - The Covid 19 Vaccination Record Card given to staff after receiving the  Pfizer BioN Tech Covid 19 Vaccine at St. Vincent’s University Hospital. Weekend feature on 3rd Covid Wave. Vaccine Passport
Coronavirus Pandemic
Photograph: Alan Betson / The Irish Times

When US soccer journalist Grant Wahl died at the age of 49 at the World Cup last December, his demise was instantly co-opted on social media for a now familiar narrative.

Within hours, online conspiracy theorists were blaming his death on the Covid-19 vaccine, despite the absence of any evidence. An autopsy showed his death was due to an aortic aneurysm, an unrelated condition.

Wahl’s case is the latest controversy in which premature deaths have been linked to Covid vaccines. When someone prominent dies at a premature age, the hashtag #DiedSuddenly starts trending on Twitter.

Since they were developed, more than 13 billion vaccine doses have been administered to 70 per cent of the world’s population. They have taken the sting out of the Covid threat and saved millions of lives; an estimated 20 million alone in the first year they were available.


But as the pandemic has receded, milder Covid variants have become dominant and vaccine fatigue has set in, critics have stepped up their attacks.

Like all medical products, vaccines can have side effects. Regulators internationally have identified a rare risk of heart inflammation (myocarditis or pericarditis) following vaccination.

The Health Products Regulatory Authority (HPRA), which oversees the safety of vaccines and other medicines in Ireland, has supplied its latest figures to The Irish Times.

Since the vaccines were introduced, 20,758 reports of suspected side effects have been notified to the regulator; only 2,852 reports were received in 2022.

Overall, the reports show the benefits of Covid-19 vaccines outweigh the risks, the authority says.

Up to the end of December the HPRA had received 122 reports of deaths among people who had been vaccinated, out of more than eight million doses administered in the State.

“It can be expected that fatalities due to progression of underlying disease or natural causes will continue to occur, including following vaccination. This does not mean that the vaccine caused the deaths,” a spokeswoman said.

Almost 1,000 of the reports sent to the HPRA relate to heart issues following Covid vaccination. It stresses these 965 reports may describe coincidental events that have occurred post-vaccination but might have occurred anyway. Most of the reports involved events such an irregular heart beat, palpitations or chest pain.

Although 29 of these patients died, the spokeswoman points out that most were “at an advanced age” and had existing medical conditions or were receiving other medication.

Suspected heart inflammation accounted for 133 reports – 51 involving myocarditis (inflammation of the heart muscle), 60 pericarditis (inflammation of the lining of the heart) and 22 involving both. “Less than five” of these patients died. Most cases occurred within 14 days of vaccination. Five cases involved an adolescent.

The HPRA says: “Where outcome information is available on these cases, they have been reported as recovered/recovering.”

“As stated in the product information for the mRNA vaccines, myocarditis and pericarditis are known but very rare potential side effects [ie, up to one in 10,000 vaccinated individuals may be affected].”

Robert Byrne, professor of cardiovascular research at the RCSI, says the link between Covid vaccination and myocarditis is “very rare but definitely an entity”. Since the vaccines were introduced, he and other colleagues have come across one case with a temporal association between vaccination and the inflammatory condition.

Angie Brown, medical director with the Irish Heart Foundation, says she has not seen any cases post-vaccination but has seen patients with myocarditis from the Covid infection itself.

Another cardiologist, who declined to be identified, agreed he had come across very few cases of vaccine-related myocarditis but said he had concerns about the number of patients presenting with atrial fibrillation and fast heartbeats (inappropriate sinus tachycardia) after receiving boosters.

The HPRA says it evaluates reports of suspected adverse reactions that come in from medics or members of the public and submits them to a database maintained by the EMA, known as EudraVigilance.

It shows Ireland has submitted 10,857 reports of adverse events linked to the Pfizer vaccine, and 2,246 relating to Moderna – about 1 per cent of all reports received.

EU member states and the EMA monitor this data for any new safety issues. “As for all medicines, should a safety issue arise, timely and appropriate regulatory action will be taken,” the authority adds.

While investigations are continuing to fill in the knowledge gaps around vaccines, amid some concerns over the lack of an evidence base, data shows the risk from Covid greatly exceeds anything posed by vaccines. In England and Wales, for example, more than 160,000 deaths have been registered as being caused by Covid since the start of the pandemic, against 52 registered as caused by a Covid vaccine.