After an impressive headline circulated over the weekend – that 23 patients died in Norway after receiving an injection of Covid-19 – The street contacted the Norwegian Medicines Agency to find out more details about what happened.
Norwegian health officials say they have now revised the guidelines on who should get Covid-19 vaccines made by Pfizer (PFE) – Get report and BioNTech (BNTX) – Get report, after 23 deaths among frail and elderly people were considered “associated” with recent Covid-19 vaccinations. More than half of those who died, 13, were evaluated. The agency believes that these fatalities may be linked to common adverse reactions from 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 collect the necessary information. “Pfizer’s immediate thoughts are with bereaved families,” said Jerica Pitts, Pfizer’s director of global media relations, in an email to The street on Sunday. But Pitts pointed out that the number of incidents so far is not alarming and expected, according to Norwegian health officials.
For perspective, 42,003 people received the first dose of the vaccine in Norway by Friday, so deaths are a small fraction of the total vaccine. In addition, Norway, which has a population of just over 5 million, has less than 58,600 known cases of Covid-19 and less than 517 deaths attributed to the virus, according to data from Johns Hopkins. This proportion alone looks much worse than that of vaccinated vs. deaths potentially linked to the vaccine.
Still, death reports “suggest” that adverse reactions common to the messenger RNA vaccine may have contributed to a fatal outcome in some fragile patients, say Norwegian health officials.
The 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 began to be distributed in Norway on 27 December.
The street: Why did the agency issue this warning?
Norwegian Medicines Agency: The Norwegian register of adverse drug reactions is a national health register, required to report statistics to the public. At the highest political level, the public was promised full transparency about the reported ADRs of Covid-19 vaccines. … In Norway, we have a “notification culture” for vaccine ADRs, where the normal procedure is to report all suspected adverse reactions to new vaccines. Health professionals in Norway have a low threshold for reporting possible adverse reactions, even when causal relationships appear very obscure.
The street: It seems that you believe that these deaths are probably related to the adverse side effects of vaccines. Could you expand on that? Are there any side effects that you find most worrisome?
Norwegian Medicines Agency: For privacy reasons, we are unable to provide detailed information on this, but … all reports are about elderly people with serious underlying illnesses. Most of them experienced the side effects expected from the vaccine, such as nausea, vomiting, fever and local reactions at the injection site.
All deaths that occur in the first days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine that occur in the first days after vaccination can contribute to a more serious course and fatal outcome in patients with serious underlying disease.
The street: How old were those who died after receiving the injections?
Norwegian Medicines Agency: All deaths fall in the age group of 75 years or more.
The street: Do these deaths make you question how the vaccine is given to that population of elderly people who are sick?
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 assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health updated the Covid-19 vaccination guide with more detailed advice on vaccinating frail elderly people.
We are now asking doctors to continue with the vaccination, but to make additional assessments of very sick people, whose underlying condition could be made worse by it. This assessment includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.