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FRANKFURT (Reuters) – Norway has changed its policy on the use of Pfizer and BioNTech’s COVID-19 vaccine to consider excluding terminally ill patients, following reports of deaths in very fragile recipients after the inoculation, BioNTech said on Monday.
“The Norwegian health authorities have now changed (their) recommendation for the vaccination of terminally ill patients (clinical frailty scale 8 or higher)”, BioNTech.
The Clinical Frailty Scale, a classification system widely used in the care of the elderly, defines grade 8 patients as nearing the end of their life and generally unable to “recover from a minor illness.”
The Norwegian Medicines Agency said in a statement released on Friday and updated on Monday that “common side effects may have contributed to a severe course in frail elderly”.
As of January 14, 23 reports of suspected deaths have been submitted to the Norwegian health register, he said.
“An assessment should be done for each individual patient to find out whether the benefits of the vaccination outweigh the risks of possible side effects,” the Norwegian agency said.
In Norway, an average of 400 people die each week in nursing homes and long-term care facilities, the medicines agency said.
German Health Minister Jens Spahn told a press briefing on Monday that the country’s vaccine regulator did not see the need to revise the guidelines and was in contact with his Norwegian counterparts.
Vaccine safety is drawing the attention of the global public after drugmakers developed blazing-fast gunfire to stem a pandemic that has killed more than 2 million people.
American and European vaccine developers have pledged to meet the scientific standards against which their immunizations will be held up in the race to contain 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 would appear that the number of observed deaths is not significantly higher than expected numbers, but this will need to be continuously reviewed in all countries where it can be done,” he said. .
Reporting by Ludwig Burger; Additional reporting by Andreas Rinke in Berlin; Editing by Alex Richardson
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