After a striking headline circulated over the weekend -- that 23 patients in Norway died after getting a Covid-19 shot -- TheStreet reached out to the Norwegian Medicines Agency to find out more details of what happened.
Norwegian health officials say they have now revised guidelines on who should get the Covid-19 shots made by Pfizer (PFE) - Get Pfizer Inc. Report and BioNTech (BNTX) - Get BioNTech SE Report, after 23 deaths among the frail and elderly were believed to be "associated with" recent Covid-19 vaccinations. More than half of those who died, 13, have been assessed. The agency believes those fatalities might be linked to common adverse reactions from the vaccine, known as BNT162b2.
A Pfizer spokesperson said that the company and its partner, BioNTech, are "aware" of the deaths and are working with the Norwegian agency to collect necessary information. Pfizer's "immediate thoughts are with the bereaved families," said Jerica Pitts, Pfizer's director of global media relations, in an email to TheStreet on Sunday. But Pitts pointed out that the number of incidents is so far not alarming and to be expected, according to Norwegian health officials.
For perspective, 42,003 people have been given the first dose of the vaccine in Norway as of Friday, so the deaths are a tiny fraction of the total vaccinated. Also, Norway, which has a population of slightly more than 5 million, has fewer than 58,600 total known cases of Covid-19 and under 517 deaths attributed to the virus, according to Johns Hopkins data. That ratio alone appears far worse one than that of the vaccinated vs. deaths potentially linked to the vaccine.
Still, the reports of deaths "suggest" that common adverse reactions to the messenger RNA vaccine may have contributed to a fatal outcome in some frail patients, says Norwegian health officials.
Following is a lightly edited exchange between TheStreet and the Norwegian Medicines Agency about the deaths, which occurred after the first dose of the vaccine, which began getting distributed in Norway on Dec. 27.
TheStreet: Why did the agency put out this notice?
Norwegian Medicines Agency: The Norwegian Adverse Drug Reaction registry is a national health registry, 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 vaccine ADRs, where the normal procedure is to report all suspected adverse reactions for new vaccines. Health care professionals in Norway have a low threshold for reporting possible adverse reactions, even when the causal relationships appear very unclear.
TheStreet: It sounds like you believe these deaths were likely linked to common adverse side effects of the shots. Could you expand on that? Is there any side effect that you find most concerning?
Norwegian Medicines Agency: For privacy reasons, we can not provide detailed information about this, but ... all reports are about elderly people with serious 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 within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination may contribute to more serious course and fatal outcome in patients with severe underlying disease.
TheStreet: How old were those who died after getting the shots?
Norwegian Medicines Agency: All deaths fall into the age group of 75 years or older.
TheStreet: Do these deaths make you question how the vaccine is given to that population of the elderly who are sick?
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 assess 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 frail.
We are now asking for doctors to continue with the vaccination, but to carry out extra evaluation of very sick people whose underlying condition might be aggravated by it. This evaluation includes discussing the risks and benefits of vaccination with the patient and their families to decide whether or not vaccination is the best course.