Reviews find no link between Covid-19 vaccines and deaths, regulator says

Death certs not routinely examined during inquiries into fatalities where side-effects suspected

Official reviews of cases where people died in the months after receiving a Covid-19 vaccine do not routinely involve checks of death certificates, the State’s medical regulator has said.

The Health Products Regulatory Authority (HPRA) has reviewed the cases of more than 100 people who have died after being administered one of the authorised vaccines, on foot of reports it has received of suspected side-effects.

“A causal role of Covid-19 vaccination has not been confirmed in any case,” a HPRA spokeswoman said.

The authority says the time between vaccination and death varied from one to 81 days in the reports examined and that just because a person died in the period after vaccination did not mean the two events were causally related.

“Reports describing a death are carefully reviewed,” the HPRA stated in its latest update on the safety of vaccines. “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.”

Asked whether the authority asked for death certificates when reviewing reports of fatalities, the spokeswoman said the HPRA does not routinely receive them. When provided, the information on the certificate is included within assessment of the case.

To date, death certificates have been submitted in only a small number of cases, she said, and none of these described Covid-19 vaccination as contributory or causal. Death certificate are available for €20 through HSE civil registration services, though not, currently, online.

The HPRA says that of the 101 reports of deaths after vaccination up to January 11th, information was provided for 95 reports. The median interval for these reports was 5½ days and the median age in the group was 81 years. More than 7.6 million vaccine doses had been administered by this time.

Individual reports of side-effects alone are rarely sufficient to establish causation, the spokeswoman told The Irish Times.

“It is essential that the totality of data is examined, including that from voluntary reporting systems, as well as from literature, epidemiological studies and clinical trials, to reach robust conclusions on any causal relationship.”

Suspected side-effects

The reviews seek to identify any missing information relevant to assessment and which may need to be followed up.

“As events described in reports of suspected side-effects can occur anyway in the population and could represent background events, information such as medical history, concurrent illnesses, concomitant medication and any findings on postmortem are routinely sought,” she said.

“In many reports, information may be missing, in particular at the time an initial report is made.”

Reports describing a fatality as a suspected side-effect of a product are notified to the HPRA by a health professional or members of the public. They are then reviewed by the HPRA to confirm a temporal association, ie, that the death occurred after vaccination.

As with all medicines, some people will experience side-effects following a Covid-19 vaccine, she said. “Covid-19 vaccines have now been used extensively across the EU and internationally, with the vast majority of expected side-effects mild to moderate in nature.”

The benefits of vaccination in preventing severe outcomes from the virus are “very well established and far outweigh the potential side effects”

Paul Cullen

Paul Cullen

Paul Cullen is Health Editor of The Irish Times