Covid-19: Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds
BMJ 2021; 373 doi: https://doi.org/10.1136/bmj.n1372 (Published 27 May 2021) Cite this as: BMJ 2021;373:n1372Read our latest coverage of the coronavirus pandemic
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Dear Editor:
This misleading title feeds the anti-vaxxer movement, and contributes to vaccine hesitancy among the public. A more accurate title would be, “Examination of Norwegian review does not show link between Pfizer-BioNTech vaccine and nursing home deaths.”
Quoting from the review(1): “There are around 35,000 nursing home patients in Norway and about 45 deaths among these patients per day.”
The review did not report what the actual deaths were after vaccination. That fundamental defect should have kept the review from being published. Unless there was a documented increase in deaths, attributing any of them to the vaccine is unwarranted speculation.
Again quoting the review:
“It must be emphasised (sic) that these estimates are very uncertain….”
“Many of the reports did not contain sufficient clinical information to form an impression of the patient’s clinical course and a possible causal link between vaccination and death. Almost half of the reporting parties did not submit additional information. In particular, there was a lack of information about which phase of life the patients were in, and whether their health and general condition were already rapidly or slowly deteriorating before vaccination.”
“It is therefore practically impossible to determine with any certainty how much of a role the vaccine played in the deaths.”
“Our findings cannot…be used to estimate the incidence of vaccine-related deaths.”
“Such an assessment requires nuanced and detailed clinical information, which in many cases was not available. The estimates are therefore uncertain.”
To publish “likely” conclusions after so many caveats was inappropriate for the review, and should not have been further publicized by BMJ.
1. Wyller TB, Kittang BR, Ranhoff AH, Harg P, Myrstad M. Nursing home deaths after COVID-19 vaccination. Tidsskr Nor Legeforen 2021;141. doi:10.4045/tidsskr.21.0383. https://tidsskriftet.no/en/2021/05/originalartikkel/nursing-home-deaths-....
Competing interests: No competing interests
COVID-19 mRNA Vaccines and Frail Patients
Dear Editor,
In their interesting and recent report, T.B. Wyller et al conclude that 0.35% of nursing home patients in Norway vaccinated with BNT162b2 showed fatal adverse reactions related to the vaccine [1]. After careful assessment of 100 cases, they considered to have found “probable” causal link in 10% of them, and “possible” in a further 26% [1].
Overall, as T.B. Wyller et al present, some elderly people or frail patients until that moment clinically stabilized, showed shortly after receiving a mRNA vaccination a sudden and unexpected impairment of their general condition (mainly with cardiac, respiratory, neurological or gastrointestinal symptoms), deteriorating rapidly, and resulting in multiorgan failure and death. The pathogenesis of these unexpected fatal outcomes is clearly unknown. It could involve a singular kind of multisystem inflammatory syndrome in adults (MIS-A) [2], or any other. More studies are needed to further understand their common mechanisms.
It should not be overlooked that elderly or frail patients were not widely included in main vaccination trials [3,4], and despite this those persons are prioritary in current vaccination strategies, as they are the most at risk. We share the view that massive COVID-19 vaccination is absolutely essential to eradicate this pandemic, but strongly agree with T.B. Wyller et al on the need for a more individualized approach for COVID-19 vaccination in some cases [1]. In particular, we must carefully assess benefits versus risks in the eldest and frailest patients.
1 Wyller TB, Kittang BR, Ranhoff AH, Harg P, Myrstad M. Nursing home deaths after COVID-19 vaccination. Tidsskr Nor Legeforen 2021;141. doi:10.4045/tidsskr.21.0383.
2 Salzman MB, Huang C-W, O’Brien CM, Castillo RD. Multisystem inflammatory syndrome after SARS-CoV-2 infection and COVID-19 vaccination. Emerg Infect Dis. 2021 July. DOI: 10.3201/eid2707.210594
3 Polack FP, MD, Thomas SJ, MD, Kitchin N, MD, Absalon J, MD, Gurtman A, MD, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020; 383:2603-2615. DOI: 10.1056/NEJMoa2034577.
4 Baden LR, MD, El Sahly HM, MD, Essink B, MD, Kotloff K, MD, Frey S, MD, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med 2021; 384:403-416. DOI: 10.1056/NEJMoa2035389.
Competing interests: No competing interests