After a notable headline spread over the weekend – that 23 patients died in Norway after receiving a Covid-19 shot – The street has reached out to the Norwegian Medicines Agency to find out more about what happened.
Norwegian health officials say they have now reviewed the guidelines on who would get the Covid-19 shots that Pfizer made (PFE) – Get report and BioNTech (BNTX) – Get report, after 23 deaths among the debilitated and elderly, they are believed to be “related” to recent vaccinations against Covid-19. More than half of those who died (13) were judged. The agency believes the deaths could be linked to general adverse reactions to the vaccine, known as BNT162b2.
A Pfizer spokesman said the company and its partner, BioNTech, were ‘aware’ of the deaths and were working with the Norwegian agency to gather the necessary information. Pfizer’s “immediate thoughts are with the grieving families,” Jerica Pitts, Pfizer’s director of global media relations, said in an email to The street on Sunday. But Pitts pointed out that the number of incidents so far is not alarming and that it is to be expected, according to Norwegian health officials.
For perspective, 42,003 people were given the first dose of vaccination in Norway from Friday, so the deaths are a small fraction of the total vaccine. Also in Norway, which has a population of just over 5 million, there are fewer than 58,600 cases of Covid-19 and fewer than 517 deaths attributed to the virus, according to Johns Hopkins data. This ratio alone looks much worse than that of the vaccinated versus deaths that may have been linked to the vaccine.
Nevertheless, death reports suggest that general adverse reactions to the messenger RNA vaccine in some debilitated patients could have contributed to a fatal outcome, Norwegian health officials say.
This is followed by a light edited exchange between The street and the Norwegian Medicines Agency on the deaths, which occurred after the first dose of the vaccine, which began spreading in Norway on 27 December.
The street: Why did the agency issue this notice?
Norwegian Medicines Agency: The Norwegian Register of Harmful Drugs is a national health register that is obliged to report statistics to the public. At the highest political level, the public has been promised full transparency of the reported ADRs of the Covid-19 vaccines. … In Norway, we have a ‘reporting culture’ for ADRs against vaccines, where the normal procedure is to report all suspected side reactions to new vaccines. Healthcare professionals in Norway have a low threshold for reporting possible adverse reactions, even if the causal relationships seem very unclear.
The street: It sounds like you believe these deaths were probably linked to common adverse side effects from the shots. Can you expand on that? Is there any side effect that affects you the most?
Norwegian Medicines Agency: For privacy reasons, we are unable to provide detailed information on this, but … all reports deal with the elderly with severe underlying disorders. Most of them experienced the expected side effects of the vaccine, such as nausea, vomiting, fever and local reactions at the injection site.
All deaths that occur within the first few days after vaccination are carefully assessed. We can not rule out that adverse reactions to the vaccine that occur within the first days after vaccination may contribute to a serious course and fatal outcome in patients with severe underlying disease.
The street: How old were those who died after getting the shots?
Norwegian Medicines Agency: All deaths fall in the age group of 75 years or older.
The street: Do you question this deaths question how the vaccine is given to the population of elderly people who are ill?
Norwegian Medicines Agency: The Norwegian Medicines Agency approves the vaccine, but the National Institute of Public Health is responsible for distribution. The Norwegian Medicines Agency and the National Institute of Public Health jointly review all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the vaccination guide for Covid-19 with more detailed advice on vaccinating elderly people who are debilitated.
We are now asking doctors to continue the vaccination, but to do extra sick people whose underlying condition may be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide if vaccination is the best way.