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Should I be concerned about the news from Norway?

Question: I just read that Norway is investigating 23 deaths in frail and elderly patients after vaccination.  I’m an older person with underlying conditions.  Should I be concerned?

Answer: Short answer: Please talk with your doctor, and please know that there’s not yet any reason to be concerned.  While the Pfizer trial did not include long-term care residents, it did include many older people with underlying conditions and no serious safety concerns were observed (see Q&A of 12/10). Read on for more details.

Norway Experience: The BMJ published a news report on this issue yesterday, which is a helpful synthesis that also provides an answer to your question.  In response to 23 frail, elderly nursing home residents in Norway having died shortly after receiving the Pfizer vaccine, Steinar Madsen, medical director of the Norwegian Medicines Agency (NOMA), told The BMJ, “It may be a coincidence, but we aren’t sure… There is no certain connection between these deaths and the vaccine.”  He further stated, “We are not alarmed or worried about this, because these are very rare occurrences and they occurred in very frail patients with very serious disease… 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.” The BMJ reports, “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.” 

Coincidence vs. Causation: Deaths in nursing homes are common.  As discussed in our Q&A of 5/27, during non-COVID times about 21% of all deaths in the USA occur in nursing homes (534,714 deaths in nursing homes in 2017).  Given this reality, it’s very difficult to untangle whether the nursing home deaths that occur soon after vaccination are coincidence or actually related to the vaccination.  Indeed, this was one of the main reasons the CDC vaccination advisory panel’s lone dissenter voted against prioritizing residents in long-term care facilities.  As STATNews reported last month, Advisory Committee on Immunization Practices (ACIP) member Helen Keipp Talbot “warned that vaccinating this population at the start of the vaccine rollout is risky, because long-term care residents have a high rate of medical events that could be confused as side effects of vaccination and undermine confidence in the vaccines. “And I think you’re going to have a very striking backlash of, ‘My grandmother got the vaccine and she passed away,’” she said at the time.”  In an interview with STATNews she elaborated,”I fear a loss of confidence in the vaccine. That the vaccine will actually truly be safe, but there will be temporally associated events and people will be scared to use the vaccine. And we won’t be able to get our kids back in school and people back at work — the things that are important.”