After a surprising headline circulated over the weekend – that 23 patients in Norway died after receiving a shot of Covid-19 – Street contacted the Norwegian Medicines Agency for more details on what happened.
Norwegian health officials say they have now revised guidelines on who should receive Cfid-19 shots fired by Pfizer (PFE) – Get the report and BioNTech (BNTX) – Get the report, after 23 deaths among frail and elderly people, were believed to be “associated” with recent vaccinations against Covid-19. More than half of the deaths, 13, have been assessed. The agency believes these fatalities could be related to common adverse reactions to the vaccine, known as BNT162b2.
A Pfizer spokesman 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 grieving families,” Jerica Pitts, director of global relations with Pfizer, said in an email to Street Sunday. But Pitts noted that so far the number of incidents is not alarming and is to be expected, according to Norwegian health officials.
In perspective, in Norway the first dose of vaccine was administered to 42,003 people as of Friday, so the deaths are a small fraction of the total vaccines. In addition, Norway, which has a population of just over 5 million, has fewer than 58,600 known cases of Covid-19 and fewer than 517 deaths attributed to the virus, according to data from Johns Hopkins. Only this ratio seems much worse than that of vaccinated versus potentially vaccine-related deaths.
However, reports of deaths “suggest” that common adverse reactions to the messenger RNA vaccine may have contributed to a fatal outcome in some fragile patients, according to Norwegian health officials.
Below is a slightly edited exchange between Street and the Norwegian Medicines Agency on deaths occurring after the first dose of vaccine, which began distribution in Norway on 27 December.
Street: Why did the agency issue this notice?
Norwegian Medicines Agency: The Norwegian Register of Adverse Drug Reactions is a national health register, required to communicate statistics to the public. At the highest political level, the public has been promised full transparency of the reported ADRs for Covid-19 vaccines. … In Norway, we have a “reporting culture” for vaccine ADRs, where the normal procedure is to report all suspected adverse reactions to new vaccines. Healthcare professionals in Norway have a low threshold for reporting possible adverse reactions, even when causal relationships seem very unclear.
Street: You seem to think that these deaths were probably related to common adverse side effects of the shots. Could you expand on that? Are there any side effects that you find most troubling?
Norwegian Medicines Agency: For privacy reasons, we cannot provide detailed information on this, but … all reports are about elderly people with severe underlying disorders. Most of them have experienced the expected side effects of the vaccine, such as nausea, vomiting, fever, and local reactions at the injection site.
All deaths that occur during the first days of vaccination are carefully evaluated. We cannot rule out that adverse reactions to the vaccine that occur in the first days after vaccination may contribute to more severe development and a fatal outcome in patients with severe underlying disease.
Street: How old were those who died after receiving the shots?
Norwegian Medicines Agency: All deaths belong to the age group of 75 years or more.
Street: Do these deaths make you wonder how the vaccine is given to the elderly patient population?
Norwegian Medicines Agency: The Norwegian Medicines Agency approves the vaccine, but the National Institute of Public Health is responsible for the distribution. The Norwegian Medicines Agency and the National Institute of Public Health jointly evaluate 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 the elderly who are vulnerable.
We now ask doctors to continue with vaccination, but to perform an additional assessment of very sick people who may aggravate their underlying condition. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether vaccination is the best course or not.