COVID-19 vaccines have enhanced reporting requirements for the Vaccine Safety Database, so reports of deaths cannot simply be compared to other vaccines

CLAIM

“More people have been killed by COVID vaccines in the past 20 months than all other vaccines in the world in the past thirty years combined. »

DETAILS

Inadequate support: An adverse event reported to VAERS does not necessarily mean that the vaccine caused the problem. The VAERS database is a tool in identifying unusual patterns that could indicate rare side effects. This requires a much more detailed investigation beyond the total number of reports.
Lack of context: COVID-19 vaccines have received emergency use authorization from the FDA to expedite deployment. Unlike full approval, this comes with greater reporting requirements to VAERS. Therefore, VAERS reports associated with COVID-19 vaccines are higher than for previous vaccines.

KEY TO GO

Manufacturers and healthcare providers should report all serious adverse events that occur after COVID-19 vaccination, whether or not they believe the vaccine is the cause. This is required under the Emergency Use Authorization that the FDA issued for COVID-19 vaccines. In 2021 and 2022, clinicians administered more than 600 million vaccines, an unprecedented number under such authorization, leading to a spike in deaths reported to VAERS. Taken together, this indicates that the spike is due to an increased reporting rate and not a true increase in deaths.

COMPLETE CLAIM: “According to the CDC’s own tracking data, which is recorded by doctors and hospitals, more people have been killed by COVID vaccines in the past 20 months, than any other vaccine in the world in the past thirty. years combined.

EXAM

Even after vaccine clinical trials have ended, the US Centers for Disease Control and Prevention (CDC) continues to monitor the safety of vaccines for the general public. One of the tools used by the CDC is called the Vaccine Adverse Event Reporting System (VAERS).

VAERS allows physicians, patients and families to report any Adverse events that occur after vaccination, whether or not the vaccine caused them. These adverse events cover a wide range of cases, including numerous medical conditions as well as motor vehicle accidents (578 reports), passive smoking (nine reports), or even “pet death” (one report). The disclaimer on the site states:

“A report to VAERS does not mean that the vaccine caused the adverse event, only that the adverse event occurred some time after vaccination.”

VAERS is a tool for identifying trends in adverse events that suggest the vaccine could potentially be the cause. However, this is only the first step in determining whether a causal link exists.

Looking only at the total number of recorded adverse events tells us very little about the safety of a vaccine. When a large number of people receive a vaccine, there will inevitably be a large number of adverse events that happen by chance in the days following the vaccination.

Unfortunately, since anyone can file a VAERS report, the entries are not always reliable. For example, in 2021, the CDC had to withdraw a false report of a 2-year-old child who died after receiving the Pfizer vaccine. The VAERS website warns:

“Certain reports may contain incomplete, inaccurate, incidental or unverifiable information […] Most reports to VAERS are voluntary, which means they are subject to bias.

VAERS reports have been repeatedly misinterpreted regarding the safety of the COVID-19 vaccine

Since the start of the COVID-19 vaccine rollout, there have been several instances of misinformation using VAERS numbers to create concerns about vaccine safety. Health Feedback has previously debunked numerous such claims bearing on the general theme of a spike in VAERS reports, such as one about an alleged increase in deaths and another about miscarriages.

Pearson Sharp, journalist and host of One American News Network, said in a tweet November 1, 2022 that “more people have been killed by COVID vaccines in the last 20 months, than all other vaccines in the world in the last thirty years, COMBINED”. Sharp’s tweet has been retweeted more than 8,300 times. Screenshots of the tweet also started circulating on social media, for example, in this Instagram post.

This claim highlighted a dramatic increase in deaths reported to VAERS in 2021 and 2022 compared to previous years. However, this is due to regulations applied to COVID-19 vaccines.

Following positive clinical trial results, the FDA has granted emergency use authorization (EUA) to three COVID-19 vaccines. This is a mechanism for faster deployment of vaccines in the event of a public health emergency.

Reporting requirements have led to an increase in VAERS entries

The EUA means that all manufacturers and healthcare providers administering COVID-19 vaccines must report all serious adverse events “whether or not the reporter believes the vaccine caused the AE [adverse event].”

This reporting requirement does not apply to other routinely used vaccines, such as influenza or childhood vaccines, as these are approved vaccines. For these approved vaccines, only deaths related to known side effects should be reported.

The FDA fully endorsed the Pfizer-BioNTech COVID-19 vaccine in August 2021 for people aged 16 and over and in July 2022 for children aged 12 to 15. It also approved the Moderna vaccine in January 2022 for all adults. However, new bivalent booster vaccines are licensed under the EUA and are therefore still subject to enhanced reporting requirements.

Since the rollout began, the American population has received more than 600 million doses of the COVID-19 vaccine. Thus, a sharp increase in VAERS reports is not surprising. Pearson’s tweet included a graph similar to the one below showing this increase. However, the tweet omitted the fact that VAERS reporting requirements for COVID-19 vaccines are higher than for previous vaccines, leaving readers with a misleading impression.

Deaths reported to VAERS
Figure 1. Deaths reported to VAERS from all locations (including U.S. and overseas) each year since 1990. Sharp increase coincides with mass deployment of licensed COVID-19 vaccines emergency use. Source: WONDER CDCNovember 2, 2022.

Additionally, a 2021 CDC study found that people who are vaccinated are less likely to die from reasons unrelated to COVID-19.[1]. This effect was confirmed after accounting for differences in age, gender and ethnicity between the vaccinated and unvaccinated groups. This directly contradicts any suggestion that COVID-19 vaccines have caused a significant increase in deaths.

Deaths reported to VAERS are being fully investigated

For VAERS death reports in the United States, CDC and FDA (Food and Drug Administration) clinicians review details using death certificates, autopsies, and medical records. With this additional information, clinicians can determine if the vaccine could plausibly have caused the death.

The CDC said this surveillance identified nine deaths causally associated with the Johnson & Johnson (J&J) COVID-19 vaccine. These deaths were due to thrombosis with thrombocytopenia syndrome, a rare side effect that causes blood clots and low platelet count. However, this represents an extremely small proportion of the nearly 19 million doses of J&J vaccine administered in the United States. It’s also important to put this in the context of COVID-19-related deaths, which vaccines help prevent. To date, more than one million people have died of COVID-19 in the United States

In December 2021, the CDC recommended health care providers should prioritize Pfizer-BioNTech and Moderna vaccines versus J&J vaccine. Then, in May 2022, the FDA placed restrictions on who could receive it.

As this case shows, the continuous vaccine surveillance system can effectively detect extremely rare causes of death that occur in less than one in a million people.

In summary, it is completely incorrect to describe death reports in VAERS as being due to the vaccine. The system is simply a place to record all post-vaccination adverse events, regardless of cause, so that they can be reviewed in detail later if necessary. The increase in deaths reported to VAERS in 2021 and 2022 results from increased reporting requirements for COVID-19 vaccines. Out of 600 million vaccine doses, nine deaths are due to side effects of a rarely used vaccine.

REFERENCE

1 – Xu et al. (2021) COVID-19 Vaccination and Non–COVID-19 Mortality Risk—Seven Integrated Health Care Organizations, USA, December 14, 2020–July 31, 2021. Weekly Morbidity and Mortality Report.