After 23 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.
“It may be a coincidence, but we aren’t sure. There is no certain connection between these deaths and the vaccine.”Steinar Madsen to 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 80 or even 90, Norwegian media NRK reported.
“There is a possibility that these common adverse reactions, that are not dangerous in fitter, younger patients and are not unusual with vaccines, may aggravate underlying disease in the elderly. We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease. We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it.”Steinar Madsen
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.
“For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant.”Norwegian Institute of Public Health
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.
The elderly are a high-risk population for COVID complications and mortality, and therefore, they are among the first in line to receive vaccines in most countries, including India.
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 50s.
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.
(With inputs from Bloomberg and The BMJ)
(This story was first published on FIT and has been republished here with permission.)
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