Health authorities in Norway have warned that Covid-19 vaccines may be too risky for those who are very old and frail and are adjusting its recommendations for vaccinating such people.
This followed an analysis of all 23 deaths in the country that occurred shortly after receiving the first dose of the vaccine, of which 13 had been autopsied.
“The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients,” Norwegian Medicines Agency chief physician Sigurd Hortemo said in a statement yesterday.
The statement noted that clinical trials of the Covid-19 vaccine jointly developed by Pfizer and BioNTech (now known as Comirnaty) did not include patients with unstable or acute illness, and few of its participants are over 85 years old.
“In Norway, we are now vaccinating the elderly and people in nursing homes with serious underlying diseases; therefore, it is expected that deaths close to the time vaccination may occur.
“In Norway, an average of 400 people die each week in nursing homes and long-term care facilities,” the agency added.
Meanwhile, the agency’s medical director Steinar Madsen reportedly said the agency is not alarmed by the developments.
“We are not alarmed by this. It is quite clear that these vaccines have very little risk, with a small exception for the frailest patients,” the Associated Press quoted him as saying.
“Doctors must now carefully consider who should be vaccinated. Those who are very frail and at the very end of life can be vaccinated after an individual assessment,” he added.
Doctors told to weigh risks against benefits
The Norwegian Institute of Public Health, which jointly assesses adverse events following vaccination together with the Norwegian Medicines Agency, has adjusted its guidance to reflect this.
It reportedly said that for elderly and frail people, the benefits of using a vaccine to reduce the risk of a severe Covid-19 infection still outweighed any side effects from the vaccine.
However, it also added, “for very frail patients and terminally ill patients, a careful balance of benefit versus disadvantage of vaccination is recommended.”
The report noted that more than 30,000 people had received the first dose of either the Pfizer or the Moderna Covid-19 vaccine since late-December. Both are mRNA vaccines.
Currently, only the elderly and those in nursing homes are eligible for Covid-19 vaccination in the country.
The vaccination plan for Malaysia has yet to be announced but is expected to target frontliners first before moving on to the elderly and those with underlying illnesses and finally, the general population.
The National Pharmaceutical Regulatory Agency (NPRA) is tasked with assessing all vaccines for safety and efficacy before granting approval for use in Malaysia.
So far, only Pfizer-BioNTech’s Comirnaty has been granted approval, and the first shipments are expected to arrive in late-February.
The NPRA is also responsible for receiving reports of any adverse events following vaccination, and determining whether it had been incidental or caused by the vaccine.
Meanwhile, Bloomberg reported that Pfizer and BioNTech are working with Norwegian authorities to investigate the deaths.
The first Europe-wide safety report on the Comirnaty will probably be published at the end of January, the report said, noting that vaccine makers are required to submit data monthly.