Misleading: Evidence from safety monitoring doesn’t indicate that COVID-19 vaccines are associated with adverse events such as cardiac arrests, heart attacks, and pulmonary embolisms. In contrast, mRNA COVID-19 vaccines were found to be over 95% effective in preventing infection among military veterans.
AFFIRMATION COMPLETE: “Judicial Watch announced today that it received 75 pages of records from the Department of Veterans Affairs detailing the adverse reactions veterans had to the COVID-19 vaccines. As of April 2021, Veteran’s Health Services reported 895 serious reactions which included: 20 cardiac arrests, 36 strokes, 15 cases of deep vein thrombosis, 10 heart attacks, and 19 pulmonary embolisms''
REVIEW
On 14 July 2021, the organization Judicial Watch claimed in this press release to have records « detailing the adverse reactions veterans had to the COVID-19 vaccines ». These alleged reactions included cardiac arrests, strokes, deep vein thrombosis, heart attacks, and pulmonary embolisms. The organization shared the press release on its Facebook, Instagram, and Twitter accounts, receiving more than 132,000 interactions on these platforms.
The claim is based on a 75-page document that the U.S. Department of Veterans Affairs (VA) sent in response to a request from Sean Dunagan, a senior investigator at Judicial Watch. While the press release suggested that the document is related to post-vaccination adverse events, the main part of the document shows otherwise, with the first 65 pages providing interim guidance for COVID-19 vaccination and prioritization in Veterans Health Administration.
All the information about adverse events appears in a nine-page presentation deck attached at the end of the VA document. This part includes one graph showing the frequency of most common side effects, such as muscle pain, headache, fever, and fatigue. Finally, three tables list the adverse events that the remaining five slides categorize based on their severity, timing, and whether they occurred among veterans or staff. The document specifies that the VA reported all these adverse events to the U.S. Vaccine Adverse Reporting System (VAERS), which means that the information is publicly available at the VAERS database.
Since the start of the COVID-19 vaccination campaigns, VAERS reports have been repeatedly misused to claim that COVID-19 vaccines are harmful. The press release by Judicial Watch is another example, as it incorrectly used VAERS reports to imply that COVID-19 vaccines caused 895 serious adverse effects among military veterans. Such claims are unsupported and misleading because VAERS reports alone can’t prove that a vaccine caused an adverse event, as Health Feedback previously explained here, here, and here.
VAERS is a vaccine safety reporting system that collects information about adverse events that occurred after receiving a vaccine. These safety monitoring systems aim to identify potential rare side effects, which are those that occur in less than 0.1% of the population. Because their frequency is very low, such effects may go undetected in clinical trials and only become apparent in very large populations. Therefore, VAERS serves as « a national early warning system » to detect possible safety problems in authorized vaccines.
Anyone can voluntarily report to VAERS any health problem following vaccination, even if it is clearly unrelated to the vaccine, like a broken arm. This means that the VAERS database contains information that is « incomplete, inaccurate, coincidental, or unverifiable », as the U.S. Centers for Disease Control and Prevention clearly warns. In other words, VAERS reports show that an adverse event occurred after vaccination. However, this temporal association is insufficient on its own to prove that the vaccine caused the event.
Showing that the vaccine caused an adverse event isn’t as simple as only citing the number of VAERS reports and instead requires further investigation. This Insight article by Health Feedback discussed the multiple aspects that one should consider when inferring causality in adverse events. Among them are the baseline rate of the adverse event in the overall population and the size of the population under consideration.
As of 22 July 2021, almost half of the U.S. population is already fully vaccinated with any of the three COVID-19 vaccines currently authorized by the U.S. Food and Drug Administration (FDA). Also, 186 million people in the U.S. have received at least one dose of the vaccine. Incidental illnesses are expected to occur in such a large population, which means that COVID-19 vaccines didn’t cause them. Likewise, VAERS reports from the VA don’t demonstrate that the vaccines caused 895 serious adverse events in military veterans.
The FDA-authorized COVID-19 vaccines demonstrated their safety and efficacy in several stages of clinical trials, which is a prerequisite to receiving emergency use authorization. Like all medical interventions, COVID-19 vaccines can have side effects, but these are generally mild and last for only a few days. In contrast, serious health problems after vaccination are rare.
Data from safety monitoring in real-world conditions is reassuring, showing that COVID-19 vaccines are very effective against the disease and have a high safety profile[1-3]. In July 2021, one large study published in Annals of Internal Medicine showed that mRNA COVID-19 vaccines were over 95% effective in preventing infection in military veterans[4]. This group is at a greater risk of severe COVID-19 than the general population due to their age and the higher prevalence of underlying health conditions. Therefore, COVID-19 vaccines are an extremely effective tool to protect them from the risks associated with the disease.
REFERENCES
- 1 – Polack et al. (2020) Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New England Journal of Medicine.
- 2 – Baden et al. (2020) Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. New England Journal of Medicine.
- 3 – Sadoff et al. (2021) Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. New England Journal of Medicine.
- 4 – Butt et al. (2021) SARS-CoV-2 Vaccine Effectiveness in a High-Risk National Population in a Real-World Setting. Annals of Internal Medicine.
