After 23 of its elderly citizens fell ill and died upon receiving their first Covid shot, Norway is warning against vaccinating persons who are 80 years and older, and the terminally ill. So far, this is the most cautious statement re:Covid-19 coming from a European health authority to date.
Norwegian health officials revealed that the 23 persons died in a very short time period after receiving their first shot of the Covid-19 vaccine. Of those deaths, 13 have been autopsied, with the results suggesting that common side effects may have contributed to severe allergic reactions in frail, elderly people, according to the Norwegian Medicines Agency.
"For those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences," the Norwegian Institute of Public Health said. "For those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant."
Their caution does not however mean that younger, healthier people should avoid being vaccinated. But it is an early indication of what to watch as countries begin to issue safety monitoring reports on the vaccines. Emer Cooke, the new head of the European Medicines Agency, has said tracking the safety of Covid vaccines, especially those relying on novel messenger RNA technology, would be one of the biggest challenges once doses are distributed widely.
In the U.S., health authorities reported 21 cases of severe allergic reactions from December 14 to 23, after administering about 1.9 million of the first doses of the Pfizer-BioNTech vaccine. That is an incidence of 11.1 cases per million doses, according to the Centers for Disease Control and Prevention.
Though both the Moderna and Pfizer-BioNTech vaccines approved so far in Europe were tested in tens of thousands of people -- including volunteers in their late 80s and 90s -- the average trial participant was in his or her early 50s. The first people to be immunized in many places have been older than that as countries rush to inoculate nursing-home residents at high risk from the virus.
Norway has given at least one dose to about 33,000 people, focusing on those considered to be most at risk if they contract the virus, including the elderly.
In France, one frail patient died in a care home, two hours after being vaccinated, but authorities said given the patient’s previous medical history there is no indication the death was linked to the vaccine. The French pharmaceutical safety agency on Thursday (Jan. 14) reported four (4) severe cases of allergic reactions and two incidents of irregular heartbeat after vaccination.
Concerning Norway's warning the Representatives for Pfizer and BioNTech have not yet responded to requests for comment.
The Pfizer-BioNTech vaccine, approved late last year, has been used most widely, with a similar shot from Moderna Inc. approved earlier this month also now being administered.
UPDATE
Unfortunately six (6) more elderly Norwegians have died from their first Covid-19 shot. According to the Norwegian Medicines Agency, the death toll now stands at 29. The latest figures lower the age group thought to be affected from 80 down to 75 year olds.
The agency revealed that until Friday, the Pfizer-BioNTech vaccine was the only dose available in Norway, and "all deaths are thus linked to this vaccine".
"There are 13 deaths that have been assessed, and we are aware of another 16 deaths that are currently being assessed," the agency said.
It further revealed that all the reported deaths are related to:
"...elderly people with serious basic disorders. Most people have experienced the expected side effects of the vaccine, such as nausea and vomiting, fever, local reactions at the injection site (swelling and pain), and worsening of their underlying condition."
Too Risky
Norway’s experience has prompted the country to suggest that Covid-19 vaccines may be too risky for the very old and terminally ill. The Norwegian Institute of Public Health has come to the conclusion that "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."
Pfizer and BioNTech say they are working with the Norwegian regulator to investigate the deaths in the country. Pfizer has however said in an e-mailed statement that "the number of incidents so far is not alarming, and in line with expectations."
Updated Saturday, January 16, 2021.
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