After a notable headline over the weekend – that 23 patients in Norway died after receiving a Covid-19 injection – The street contacted the Norwegian Medicines Agency for more information on what happened.
Norwegian health officials say they have now revised guidelines on who should get Pfizer’s Covid-19 shots (PFE) – Request report and BioNTech (BNTX) – Request report, after 23 deaths among the frail and elderly were believed to be related to recent vaccinations against Covid-19. More than half of those who died, 13, have been assessed. The agency believes those fatalities may be related to common side effects of the vaccine, known as BNT162b2.
A Pfizer spokesperson said the company and its partner, BioNTech, are “aware” of the deaths and are working with the Norwegian agency to gather the necessary information. Pfizer’s “immediate thoughts are with the next of kin,” 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 expected, Norwegian health officials said.
In comparison, 42,003 people have received the first dose of the vaccine in Norway since Friday, so the number of deaths is only a fraction of the total number of people vaccinated. Norway, with a population of just over 5 million, has less than 58,600 known cases of Covid-19 and less than 517 deaths from the virus, according to data from Johns Hopkins. That ratio alone seems much worse than that of the vaccinated vs. deaths possibly related to the vaccine.
Still, the reports of deaths “suggest” that common side effects from the messenger RNA vaccine may have contributed to fatal outcomes in some vulnerable patients, Norwegian health officials said.
Following is a slightly edited exchange between The street and the Norwegian Medicines Agency on the deaths that occurred after the first dose of the vaccine, which was distributed in Norway on December 27.
The street: Why did the agency issue this message?
Norwegian Medicines Agency: The Norwegian Adverse Drug Reaction Registry is a national health registry that is required to report statistics to the public. At the highest political level, the public has been promised full transparency of the reported side effects of the Covid-19 vaccines. … In Norway we have a “reporting culture” for vaccine adverse reactions, where the normal procedure is to report all suspected adverse reactions from new vaccines. Healthcare professionals in Norway have a low threshold for reporting possible side effects, even when the causal relationships seem very unclear.
The street: It sounds like you think these deaths were likely related to common adverse side effects from the shots. Can you elaborate on that? Is there any side effect that you find most concerning?
Norwegian Medicines Agency: For privacy reasons, we cannot provide detailed information about this, but … all reports concern elderly people with serious underlying conditions. Most of them have experienced the expected side effects of the vaccine such as nausea, vomiting, fever and local injection site reactions.
All deaths occurring within the first days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring in the first days after vaccination may contribute to a more serious course and fatal outcome in patients with a serious underlying disease.
The street: How old were those who died after taking the shots?
Norwegian Medicines Agency: All deaths fall into the age group of 75 years or older.
The street: These deaths make you wonder how the vaccine is given to that population of sick elderly?
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 Covid-19 vaccination guide with more detailed advice on vaccinating frail older people.
We are now asking doctors to continue with the vaccination, but to conduct additional evaluation of very sick people whose underlying condition could worsen. This evaluation includes discussing the risks and benefits of vaccination with the patient and their family to decide if vaccination is the best course of action.