FRANKFURT (Reuters) – Norway has changed its policy regarding the use of Pfizer and BioNTech’s COVID-19 vaccine to consider excluding the terminally ill, following reports of deaths in very frail recipients after the vaccination was given, said BioNTech Monday.
“Norwegian health authorities have now changed (their) recommendation regarding vaccination of the terminally ill (Clinical Frailty Scale 8 or higher),” BioNTech.
The Clinical Frailty Scale, a widely used classification system in elderly care, defines grade 8 patients as the end of life and usually unable to recover “even from mild illness”.
The Norwegian Medicines Agency said in a statement posted Friday and updated Monday that “common side effects have contributed to a serious course in frail elderly”.
On January 14, 23 reports of suspected deaths were submitted to the Norwegian Health Registry.
“It must be assessed for each individual patient whether the benefits of vaccination outweigh the risks of any side effects,” said the Norwegian agency.
In Norway, an average of 400 people die per week in nursing homes and long-term care facilities, the drug agency said.
German Health Minister Jens Spahn said in a newsletter Monday that the country’s vaccine regulator saw no need to revise the guidelines and that it was in contact with their Norwegian counterparts.
Vaccine safety is gaining public attention around the world after drug manufacturers evolve at lightning speed to curb a pandemic that killed more than 2 million people.
American and European vaccine developers have pledged to maintain the scientific standards against which their immunizations will be held in the race to control the virus.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said there was so far no evidence of a causal link between the deaths of vulnerable patients in Norway and vaccination.
“We don’t know yet, but it does not appear that the number of deaths observed is not significantly higher than the expected number, but this will need to be continuously investigated in all countries where it can,” he said.
Reporting by Ludwig Burger; Additional reporting by Andreas Rinke in Berlin; Editing by Alex Richardson