A recent review of randomized phase III trials of COVID-19 mRNA injections demonstrated an increased risk of hospitalization for those vaccinated compared to unvaccinated. 1 Data from the Swedish Medical Products Agency (LV) confirms that injections of COVID-19 have led to a marked increase in reported side effects, including suspected serious side effects (SSSEs) and deaths. Despite this, the constant message from the Swedish Public Health Agency (FoHM) is that the benefits outweigh the risks. The evidence does not support this claim…
To determine the relative risk of experiencing serious side effects, SSSE including death, compared to being hospitalized or dying with COVID-19, we analyzed publicly available data from the Swedish Medical Products Agency LV, l Swedish Public Health Agency, FoHM, the Swedish National Board of Health and Welfare (SoS) and Statistics Sweden (SCB). Assuming that 5% of all SSSE are reported in Sweden, our analysis shows that vaccination against COVID-19 is likely to benefit only one group: men over 90. For all other groups, the incidence of SSSE exceeded the risk of hospitalization and death from COVID-19.
Our analysis was done in three steps. In the first step, we estimated the number of people per 100,000 who were hospitalized or died from COVID-19 infection during the first year of the pandemic. We first used data on the number of people aged 10 and older who were hospitalized with (n=81,864) or died of (n=12,111, total n=93,975) COVID-19 at hospital since March 2020, the first month of infection, to June 3, 2022, by age and sex. 2.3 Additionally, as of May 30, 2022, n=4,488 people had died of COVID-19 in another setting (total n=16,599), 4 and we assumed they were all 10 years or older (a child aged 0-9 is less likely to die outside of hospital). Since the age of non-hospitalized cases was unknown, we assumed a similar age distribution to the hospitalized group, assigning cases to age groups accordingly.
To estimate COVID-19 hospitalizations and deaths during the first year of infection, from March 2020 to February 2021, we adjusted the total number of hospitalizations and deaths aged 10 years and older up to June 3, 2022 (n=98,463). ) by the proportion in the first year (53.2%, n=51,338) of all hospitalizations with COVID-19 for all ages through June 3, 2022 (n=96,522), 3 resulting in n = 52,370 cases aged 10 years and older. Population usage as of December 31, 20205 , We could then estimate the number of people hospitalized and deceased with COVID-19/100,000 during the first 12 months according to age and sex:
In the second step, we estimated the number of people who experienced at least one SSSE in the first year of vaccination/100,000 vaccinated according to the LV definition of a serious adverse event:
A report is considered serious if the suspected adverse reaction results in death, is life-threatening, involves hospitalization or prolonged hospitalization, results in disability, causes birth defects, or any other medically significant event. 6
Swedish vaccination against COVID-19 started on December 27, 2020. We include SSSE reports until the 23 December 2021. During this period, LV considered n=8496 of reported adverse events to be SSSE. 7,8,9
To estimate the number of MAB cases per vaccinated person in the groups, we used data from the FoHM. ten During the first year of vaccination, 85.4% of the population aged 12 and over had received at least one dose of vaccine. However, we lacked data on age and sex distribution, but were able to calculate the proportion vaccinated by age by combining the figure of 85.4% with data on the proportion vaccinated in different age groups up to June 19, 2022 and adjusting for the increase in vaccination coverage from December 23, 2021 to June 19, 2022. ten Based on the population as of December 31, 2021 by age and gender, 5 we were able to calculate the number of vaccinated by age group and by sex.
Of As the FoHM data showed that proportionally more women than men had been vaccinated, we adjusted this in the final model: the number increased for women and decreased for men, so that the proportion of women vaccinated is 1.0314 times higher than that of men for all age groups. This resulted in the following:
Finally, in the third step, we calculate the number of SSSE per person hospitalized or died with COVID-19. The SSSE notification fees in Sweden could be so low like 1-2%. 11.12 Since the exact SSSE reporting rate by injection of COVID-19 is unknown, we tested the results using an assumed SSSE reporting rate of 5%, 10%, or 25%. Thus, we were able to estimate the number having suffered at least one SSSE/person hospitalized with COVID-19, by age and gender:
A value > 1 suggests that vaccination against COVID-19 was disadvantageous for this group. Women and men aged 10 to 79 have been particularly affected by SSSE. Assuming a 5% SSSE notification fee, men aged 10-19 were the most disadvantaged, experiencing an incidence of SSSE 14.1 times higher than hospitalization for COVID-19. Therefore, the risks of vaccination outweigh the potential benefits in most groups and vaccination It only seems to be beneficial in men over 90. Assuming a very conservative estimate of an HSSE reporting rate of 25%, the risk outweighs the benefits for men under 40 and women under 70.
Although we have used publicly available data, the data set needed to accurately determine the benefit/risk ratio of vaccination against COVID-19 is only available to the Swedish authorities. In the interests of public health, we implore authorities to conduct a fully transparent and independent expert review of available data to provide accurate analyzes of morbidity, mortality and risk-benefit.
- Sven Román, MD, child and adolescent psychiatrist, since 2015 consultant psychiatrist working in child and adolescent psychiatry throughout Sweden
- Anette Stahel, MSc in Biomedicine, former cancer researcher at the University of Skövde
- Jonathan Gilthorpe, PhD, Associate Professor of Cell Biology, Umeå University
- Johan Eddebo, PhD, Researcher in Digitization and Human Rights, Philosophy of Religion, Uppsala University
- Niklas Lundström, PhD, MSc in Engineering Physics, Associate Professor of Mathematics, Umeå University
Declaration of conflict of interest: None declared.
- Fraiman, J, Erviti, J, Jones, M, Greenland, S, Whelan, P, Kaplan, RM & Doshi, P (2022) Serious Adverse Events of Special Interest Following mRNA Vaccination in SSRN Randomized Trials
- Socialstyrelsen (2022) Statistics on COVID-19 Official information from SoS
- National Board of Health and Welfare (2022) Covid-19 statistics; Statistics on people who died in covid-19 Official information from SoS Available via Sven Román at email@example.com
- National Board of Health and Welfare (2022) Covid-19 statistics; Statistics on patients hospitalized with covid-19 Official information from SoS Available via Sven Román at firstname.lastname@example.org
- Statistics Sweden (2022) Statistics Database – Population by age and sex Year 1860 – 2021 Official information from Statistics Sweden
- Läkemedelsverket (2021) Comirnaty – Swedish reports of suspected side effects – 17/17/2021
- Läkemedelsverket (2021) Comirnaty – Swedish reports of suspected side effects – 2021-12-23
- Läkemedelsverket (2021) Spikevax – Svenska Handlagda reports suspected side effects – 2021-12-23
- Läkemedelsverket (2021) Vaxzevria – Svenska Handlagda reports suspected side effects – 2021-12-23
- Swedish Public Health Agency (2022) Covid-19 vaccination statistics; The data on which the above statistics are based can be downloaded here (excel) Official information from FHM Available via Sven Román at email@example.com
- Jönsson, AK, Jacobsson, I, Andersson, M & Hägg, S (2006) Large Underreporting of Cerebral Hemorrhage as Drug Side Effect LT 103 (45): 3456-3458
- Rydberg, DM, Holm, L, Engqvist, I, Fryckstedt, J, Lindh, JD et al (2016) Adverse drug reactions in a tertiary care emergency medicine department – Prevalence, prevention and reporting PLOS ONE 11(9 ): e0162948