January 18, 2021 1:24:05 am
Twenty-nine people have died in Norway after being administered Pfizer’s vaccine against the novel coronavirus, Norwegian authorities have said. They added six deaths on Saturday to the number of those previously reported dead following inoculation. The new deaths lowered the age of those thought to have been affected to 75, from 80, multiple news reports said.
Until Friday, the vaccine manufactured by Pfizer-BioNTech was the only one being administered in Norway, and “all deaths are thus linked to this vaccine,” the Norwegian Medicines Agency said, according to a Bloomberg report. Thirteen deaths have been assessed so far, and all the reported deaths are in “elderly people with serious basic disorders”, the report said, quoting the agency.
Is this a serious concern?
The Norwegian authorities are saying they are not worried as yet.
“We are not alarmed by this. It is quite clear that these vaccines have very little risk, with a small exception for the frailest patients,” Steinar Madsen, medical director with the agency, told Norwegian broadcaster NRK, the AP reported.
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That said, the Norwegian authorities have adjusted their advice on who should be administered the vaccine by giving individual doctors discretion to make this decision. The suggestion is that the vaccines may be risky for very old or terminally ill people. This, the Bloomberg report said, is “the most cautious statement yet from a European health authority”.
The report said that in the judgment of the Norwegian Institute of Public Health now, “for those with the most severe frailty, even relatively mild vaccine side effects can have serious consequences”. Thus, “for those who have a very short remaining life span anyway, the benefit of the vaccine may be marginal or irrelevant”.
Madsen, quoted in the AP report, said: “Doctors must now carefully consider who should be vaccinated. Those who are very frail and at the very end of life can be vaccinated after an individual assessment.”
Were these problems unexpected?
No. A mass vaccination campaign by definition involves a very large number of people — and as a general principle, some adverse events, which could include serious side effects and deaths, should be expected.
What is critical is to determine whether the vaccine was responsible for the death. This can be complicated, and can take time to establish — doctors have to go through every case individually, and strike out all other potential causes first.
Bloomberg quoted the Norwegian Medicines Agency: “The Norwegian Medicines Agency has communicated, prior to the vaccination, that when vaccinating the oldest and sickest, it is expected that deaths will occur in a time-related context with vaccination. This does not mean that there is a causal link between vaccination and death. We have also, in connection with the reported deaths, conveyed that it is possible that common and known side effects of the vaccines may have been a contributing factor to a serious course or fatal outcome.”
Norway isn’t an outlier either.
Side effects and fatalities have been reported in the United Kingdom and the United States as well.
In India at the end of the second day of vaccinations on Sunday, the Union Health Ministry said adverse events following immunisation (AEFI) had been reported in 447 cases — less than 0.2% of the 2,24,301 beneficiaries from the priority group who had received first doses of the vaccine. Only three of these cases required hospitalisation, and two had been discharged already, the Ministry said.
What is being done about this situation now?
Pfizer and BioNTech are working with the Norwegian regulator to investigate the deaths. Bloomberg quoted Pfizer as saying that the Norwegian authorities have found that “the number of incidents so far is not alarming, and in line with expectations”.
Earlier this week, Pfizer said it was also “actively investigating”, along with federal health officials in the United States, the death of a 56-year-old physician in Florida, who died a little over two weeks after receiving the vaccine. “[But] we don’t believe at this time that there is any direct connection to the vaccine,” The New York Times, which first reported the death, quoted Pfizer as saying in a statement.
The European Medicines Agency, which assesses and supervises medicinal products in the European Union, has said that it would examine safety reports submitted by all companies authorised to supply vaccines to the EU every month, and that Pfizer’s report would be taken up later this month.
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