Study: Reporting Rates for VAERS Death Reports Following COVID-19 Vaccination, December 14, 2020-November 17, 2021. Image Credit: Anze Furlan / Shutterstock

CDC/FDA reports on VAERS – no association between vaccines and increased mortality

Although vaccines have been given against global coronavirus disease 2019 (COVID-19), many people are still hesitant to get vaccinated. Concerns about adverse vaccine reactions reported to the Vaccine Adverse Reaction Reporting System (VAERS) are one of the reasons for vaccine hesitancy.

A US population-wide study published in medRxiv* The preprint server provides information and context on deaths reported to VAERS following COVID-19 vaccination.

Study: Reporting rate of VAERS death reports after COVID-19 vaccination, December 14, 2020 to November 17, 2021. Image Credit: Anze Furlan/Shutterstock

Public Health Consequences of COVID-19 Vaccinations

After emergency use authorization for COVID-19 vaccines, more than 239 million people in the United States have received at least one dose of a COVID-19 vaccine in one year. Through July 2021, these vaccinations are associated with estimated reductions of approximately 213,000 deaths and 1.38 million hospitalizations, according to the December 2021 report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE ).

According to a research letter published in January 2022, COVID-19 vaccinations in the United States have saved more than 240,000 lives and averted more than 1.1 million hospitalizations through June 2021.

VAERS

VAERS, a national vaccine safety monitoring program established in 1990, is co-managed by the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA). The purpose of VAERS is to detect unusual or unexpected patterns of side effects caused by vaccination. It serves as an early warning system for the FDA and CDC to further investigate the vaccine.

Individuals, including patients, family members, healthcare providers and vaccine manufacturers, report side effects to VAERS. VAERS accepts the report without any evidence of an association between the vaccine and the side effect. Serious and unexpected side effects, including death, are more likely to be reported than minor side effects.

For COVID-19 vaccines, healthcare providers are legally required to report any deaths resulting from vaccination to VAERS. These side effects and deaths may be coincidental and not caused by the vaccine.

Some media have described the number of deaths reported to VAERS as a “death toll”. However, this representation is incorrect because it implies that these deaths were due to vaccination against COVID-19. Thus, incorrect interpretation of VAERS data can lead to erroneous conclusions about cause and effect.

Strengths and limitations of VAERS

VAERS can quickly detect potential safety signals. This database contains all reports from across the United States. The information it contains has the potential to detect rare side effects. In addition, VAERS data is transparent because it is publicly available.

However, VAERS data is subject to reporting bias and stimulated reporting or increased reporting due to media attention or heightened public awareness. Reported side effects are unverified. Some reports may contain missing or inaccurate information. Additionally, there is no ability to compare rates of side effects between vaccinated and unvaccinated individuals. Therefore, VAERS cannot determine if a side effect is caused by vaccination alone.

Analysis of VAERS data

This is a descriptive study of reporting rates of VAERS death reports. It includes data on the U.S. population vaccinated against COVID-19 from December 14, 2020 through November 17, 2021.

Death reporting rates per million vaccinated were calculated and compared to predicted baseline rates of death from all causes in the general population. Notification rates were calculated by dividing the number of deaths reported within 42 days of vaccination by the number of people vaccinated with at least one dose of a COVID-19 vaccine. All-cause mortality rates were determined using data from the National Vital Statistics System. All-cause death indicates incidental death or death from causes unrelated to vaccination.

Three COVID-19 vaccines were included in the analysis, the PfizerBioNTech BNT162b2 vaccine, the Moderna mRNA-1273 vaccine and the Janssen Ad26.COV2.S vaccine from Johnson & Johnson.

Notification rates above the baseline may indicate an association between vaccination and death, while notification rates below the baseline may indicate no association.

This study assessed the most common side effects in VAERS death reports after COVID-19 vaccination and compared them to the leading known causes of death in the United States. This study also examined VAERS death reports to detect signals of disproportionate reporting for COVID-19 vaccines.

Results

A total of 9,201 deaths have been reported for COVID-19 vaccinations given to people aged five and older. Death reporting rates increased with age, and males had higher reporting rates than females. Observed death reporting rates were approximately ten times lower than expected rates of death from all causes within seven days of vaccination and approximately 36 times lower than expected rates of death from all causes within 42 days of vaccination.

Notification rates for the Ad26.COV2.S vaccine were higher than notification rates for COVID-19 mRNA vaccines. However, even for the Ad26.COV2.S vaccine, reporting rates were still lower than expected all-cause mortality rates.

The most common preferred terms among death reports were signs, symptoms or non-specific investigations. Side effects reported to VAERS were either non-specific or reflective of leading known causes of death in the United States

There was a disproportionate reporting signal for VAERS death reports for the Ad26.COV2.S vaccine. This means that the vaccine-related event was reported at least twice as often as expected if there was no association.

Implications of the study

The results of this study support the safe use of COVID-19 vaccines, which may reduce vaccine hesitancy in the general population.

Conclusion

Reports of deaths following vaccination against COVID-19 were considerably lower than expected. Trends in reporting rates reflect known trends in all-cause mortality rates.

*Important Notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be considered conclusive, guide clinical practice/health-related behaviors, or treated as established information.

#CDCFDA #reports #VAERS #association #vaccines #increased #mortality

Leave a Comment

Your email address will not be published. Required fields are marked *