FRANKFURT (Reuters) – Norway has changed its policy on the use of the COVID-19 vaccine by Pfizer and BioNTech to consider excluding terminally ill patients after reports of deaths in highly fragile recipients after vaccination, BioNTech said on Monday. .
“Norwegian health authorities have now changed (their) recommendations regarding vaccination of terminally ill patients (Clinical Fragility Scale 8 or higher),” BioNTech.
The Clinical Fragility Scale, a classification system widely used in the care of the elderly, defines grade 8 patients as approaching the end of life and is usually unable to “recover even from a mild illness”.
The Norwegian Medicines Agency said in a statement published on Friday and updated on Monday that “common adverse reactions may have contributed to a serious course in frail elderly people”.
As of January 14, 23 reports of suspected deaths have been sent to the Norwegian health record, he said.
“An assessment should be carried out for each individual patient to see whether the benefits of vaccination outweigh the risks of possible side effects,” said the Norwegian agency.
In Norway, an average of 400 people die each week in nursing homes and long-term care facilities, the drug agency said.
Germany’s health minister, Jens Spahn, said at a news conference on Monday that the country’s vaccine regulator saw no need to revise the guidelines and that he was in contact with his Norwegian colleagues.
Vaccine safety is attracting global public attention after drug makers developed the dizzying speed of shots to contain a pandemic that killed more than 2 million people.
Vaccine developers in the United States and Europe have pledged to maintain the scientific standards against which their immunizations will be carried out in the race to contain the virus.
Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said there was no evidence so far of a causal relationship between the deaths of vulnerable patients in Norway and vaccination.
“We don’t know yet, but it appears that the number of deaths observed is not noticeably higher than expected, but it will need to be examined continuously in all countries where it can be done,” he said.
Reporting by Ludwig Burger; Additional reporting by Andreas Rinke in Berlin; Edition by Alex Richardson