‘Please explain’ for vaccine death claims

Researchers behind a study that claimed COVID vaccines might have played a bigger role in pandemic deaths than first expected have been asked to review their findings.

Social media feeds such as X have been bombarded with messages claiming that the potential harm caused by COVID vaccination had been ‘proven’ by recent evidence, which can be linked back to a study published earlier this month in the BMJ Network. 

The work has subsequently been flagged for review by the wider scientific community. 

The alarm was raised about the research paper: Excess mortality across countries in the Western World since the COVID-19 pandemic: ‘Our World in Data’ estimates of January 2020 to December 2022, which concluded that COVID vaccines may have played a much a larger role than first anticipated in the rise of unexplained excess deaths, both during and after the pandemic. 

 “Following concerns raised with BMJ we are investigating the quality of the research and the messaging used in the study, an expression of concern will be placed on the paper,” a BMJ spokesperson said. 

 “The messaging gave rise to widespread misreporting and misunderstanding of the work amid claims that it implies a direct causal link between COVID-19 vaccination and mortality. In fact, the researchers looked only at trends in excess mortality over time, not its causes.  

 BMJ’s research integrity team is in contact with the Princess Máxima Centre. The Centre is listed as the affiliation of three of the four authors and has already announced that it is investigating the scientific quality of this study. 

 “As part of the investigation the authors will be asked to review and respond to the concerns raised to BMJ about the quality and messaging of the paper. BMJ will then decide what further action is needed.” 

 Excess mortality has been internationally recognised as the most accurate measure for monitoring and comparing health crisis policies across geographic regions, and between 1 January 2020 and 31 December 2022, the number of excess deaths in 47 Western countries was 3,098,456. 

Excess mortality was documented in 41 countries (87%) in 2020, 42 countries (89%) in 2021 and 43 countries (91%) in 2022, and since the outbreak of the COVID pandemic, excess mortality has included not only deaths from SARS-CoV-2 infection but also deaths related to the indirect effects of the health strategies to address the virus spread and infection. 

Lead author of the original study, Dr Saskia Mostert, from the Vrije University in Amsterdam, said excess mortality during a crisis pointed to a more extensive underlying burden of disease, disablement and human suffering. 

“Although COVID vaccines were provided to guard civilians from suffering morbidity and mortality by the virus, suspected adverse events have been documented as well,” she said. 

“The secondary analysis of the placebo-controlled, phase III randomised clinical trials of mRNA COVID vaccines showed that the Pfizer trial had a 36% higher risk of serious adverse events in the vaccine group, with a risk difference of 18.0 per 10 000 vaccinated. 

“The Moderna trial had a 6% higher risk of serious adverse events among vaccine recipients, with a risk difference of 7.1 per 10 000 vaccinated, and these serious adverse events either lead to death, are life-threatening, require inpatient (prolongation of) hospitalisation, cause persistent/significant disability/incapacity, concern a congenital anomaly/birth defect or include a medically important event according to medical judgement.  

“This commonality hinders clinical suspicion and consequently its detection as adverse vaccine reactions.” 

The team highlighted that previous research had confirmed the profound under-reporting of adverse events after immunisation, including deaths, noting that French studies had suggested that COVID mRNA vaccines were gene therapy products requiring long-term, stringent adverse events monitoring. 

“Although COVID containment measures and COVID vaccines were implemented to protect citizens from suffering morbidity and mortality by the COVID virus, they may have detrimental effects that caused inferior outcomes as well,” Dr Mostert said. 

“Vulnerable populations in need of acute or complex medical treatment, such as patients with cardiovascular disease, cerebrovascular conditions, diabetes and cancer, were hurt by these interventions due to the limited access to and delivery of medical services. 

“Shortage of staff, reduced screening, delayed diagnostics, disrupted imaging, limited availability of medicines, postponed surgery, modified radiotherapy and restricted supportive care hindered protocol adherence and worsened the condition and prognosis of patients.  

“However, deaths caused by restricted healthcare utilisation and socioeconomic turmoil are difficult to prove. A critical challenge in excess mortality research is choosing an appropriate statistical method for calculating the projected baseline of expected deaths to which the observed deaths are compared.” 

When expressed graphically, the linear excess mortality trendline was almost horizontal.