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Serious illness HSE issues new advice on Covid-19 vaccine for very frail elderly after a number of deaths in Norway

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Doctor prepares a syringe of the Pfizer-BioNTech Covid-19 vaccine

Doctor prepares a syringe of the Pfizer-BioNTech Covid-19 vaccine

Doctor prepares a syringe of the Pfizer-BioNTech Covid-19 vaccine

Health staff who are administering the Covid-19 vaccine in long-term care settings across the country have been told it is not appropriate to give it to residents whose duration of life may be shorter than the length of time it will take for the jab to work.

The advice is being issued by HSE chief clinical officer Dr Colm Henry following 23 deaths of a number of very frail elderly patients in Norway after getting the Covid-19 vaccine.

The Norwegian Medicines Agency (NOMA) said there is no certain connection between the deaths and the vaccine but there is a possibility that common adverse reactions that are not unusual could aggravate underlying illness in the elderly.

It said it was not alarmed or worried because they are very rare cases and they occurred in very frail patients with very serious disease.

In a letter to clinicians Dr Henry said: “Given that the benefit from vaccination begins only about 10–14 days following the first dose and full protection is not achieved until 7-14 days following the second dose of vaccine currently in use, it is not appropriate to vaccinate people if their expected duration of life is less than that for the vaccine to take effect and if, in that context, their overall care is focused on comfort and dignity.”

He said that to date well over 10 million Covid-19 vaccines have been administered globally, with vaccination programmes prioritising those at high risk, including older people.

“All events reported as possible side effects following vaccination are being closely monitored. It is important to note that fatalities will occur from natural causes or background illnesses, and will continue to do so, during any vaccination campaign.”

Dr Henry said NOMA and the Norwegian National Institute of Public Health have reported 23 deaths connected temporally with the Pfizer BioNtech vaccine of which 13 have been assessed.

“The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some very frail elderly individuals.

“The National Immunisation Advisory Committee has reviewed the available information and has advised that the vaccination rollout should continue as planned and reiterate that, as in all situations, a careful, individual assessment of the risk/benefit ratio for those receiving a Covid-19 vaccine should be carried out.”

All members of the vaccination team should have undergone appropriate training regarding vaccinations and the management of immediate reactions.

“They should be aware of situations where vaccines are contraindicated and precautions to be taken. Vaccine should be deferred in people with acute febrile illness, those who are acutely unwell until recovery, and for four weeks following diagnosis of Covid-19,” he added.

Residential care facility staff should be aware of expected side effects following administration of a vaccine and should be familiar with the processes following vaccination.

“Specifically, they should know who to contact if a resident becomes unwell following vaccination and the reporting process for any adverse events.

“In addition, given that the benefit from vaccination begins only about 10–14 days following the first dose and full protection is not achieved until 7-14 days following the second dose of vaccine currently in use, it is not appropriate to vaccinate people if their expected duration of life is less than that for the vaccine to take effect and if, in that context, their overall care is focused on comfort and dignity,” he added.

Dr Henry said that matters relating to decisions on the potential benefit or otherwise of the vaccine for those who are extremely frail and/or approaching end of life should form part of the considerations during the consent process with the patient, and in consultation with their families as appropriate, and may need input of more than one healthcare professional.

“Liaison between the person’s GP and the nursing staff of the long-term residential care facility may be required to provide the best advice to support the process of consent to vaccination.

"Where the vaccination is deferred or declined on the basis of this process, a note should be made in the person’s healthcare record.”

The HSE plans to concentrate the roll-out of the vaccine this week more on long-term care facilities than in hospitals.

Health Minister Stephen Donnelly said the plan is that all nursing home residents will have received their first vaccination dose by next Sunday.

In a statement Pfizer and BioNTech said they are aware of reported deaths following administration of the vaccine.

“We are working with the Norwegian Medicines Agency (NOMA) to gather all the relevant information.

“Norwegian Authorities have prioritised the immunisation of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some which are terminally ill.

“NOMA confirm the number of incidents so far is not alarming, and in line with expectations.

"All reported deaths will be thoroughly evaluated by NOMA to determine if these incidents are related to the vaccine.

"Norwegian Health Authorities have now changed its recommendation in relation to vaccination of the terminally ill. Our immediate thoughts are with the bereaved families.“

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