After 29 deaths shortly after receiving the COVID vaccine were reported in Norway, the country has warned that the vaccines may be risky for old and terminally ill people, reported Bloomberg.
Doctors in Norway have been told to conduct more thorough evaluations of very frail elderly patients in line to receive the Pfizer BioNTech vaccine - the candidate administered in the concerned cases.
Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told The BMJ,
The agency has probed 13 of these deaths, finding that common side effects of mRNA vaccines, such as fever, nausea, and diarrhoea may have contributed to fatal reactions in frail elderly people.
Importantly, this does not mean the vaccine is unsafe for younger people. These complications have only been reported in the elderly group - frail, old and aged over 75 or even 90, Norwegian media NRK reported.
Of 29 cases of potential side effects investigated by Norwegian authorities, nearly 75 were in people age 80 or older, the regulator said in a report.
In a statement, Pfizer said that they were working with the Norwegian regulators to gather all relevant information, and that NOMA confirmed that the number of incidents so far is not alarming, and in line with expectations.
While both the approved vaccines in Europe - Moderna’s and Pfizer’s - have been tested in thousands of people, including volunteers in their 80s and 90s - the average age of participants was early 50’s.
The first Europe-wide safety report on the Pfizer-BioNTech vaccine will probably be published at the end of January, the regulator’s key medicines committee said on Friday, 15 January, reported Bloomberg.
According to Emer Cooke, the new head of the European Medicines Agency, tracking the safety of COVID vaccines, especially those relying on novel technologies such as messenger RNA, would be one of the biggest challenges once shots are rolled out widely.
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Published: 16 Jan 2021,02:16 PM IST