The COVID-19 vaccines are safe and effective; claim that they have caused an “international medical crisis” is baseless

CLAIM
“there is an international medical crisis due to the diseases and deaths co-related to the administration of products known as ‘COVID-19 vaccines’”
DETAILS
Inadequate support: The claim that the vaccines have caused an international medical crisis due to millions of adverse effects, miscarriages, and over 70,000 deaths is unsupported. There is no evidence that the COVID-19 vaccines are causing a rise in mortality or miscarriages.
Factually inaccurate: Large-scale studies show that the COVID-19 vaccines don’t increase the risk of negative pregnancy outcomes.
Misleading: Adverse event reports in databases like VAERS and EudraVigilance are important tools for monitoring vaccine safety. But reports in these databases alone aren’t sufficient evidence that the COVID-19 vaccines caused an adverse event, and reports need to be further analyzed to establish causality. Claims that excess deaths are due to COVID-19 vaccines are due to misleading interpretations of data.
KEY TAKE AWAY
Scientific evidence from clinical trials and safety monitoring indicate that the COVID-19 vaccines are safe and effective. In the first year of the COVID-19 vaccine campaign, these vaccines were estimated to have prevented 19.8 million deaths due to COVID-19. There is no evidence that these vaccines have caused a rise in mortality or sudden deaths, and studies have shown that the vaccines don’t increase the risk of negative pregnancy outcomes. The claim that the COVID-19 vaccines have caused an international medical crisis is baseless.

FULL CLAIM: “there is an international medical crisis due to the diseases and deaths co-related to the administration of products known as ‘COVID-19 vaccines’”; “We are currently witnessing an excess in mortality in those countries where the majority of the population has received the so called ‘COVID-19 vaccines’”; “The large number of sudden deaths in previously healthy young people who were inoculated with these ‘vaccines’, is particularly worrying, as is the high incidence of miscarriages and perinatal deaths which have not been investigated”.

REVIEW


On 1 September 2022, a team of researchers at the MRC Center for Global Infectious Disease Analysis at the Imperial College London, published a study in The Lancet where they estimated that the COVID-19 vaccines prevented 19.8 million deaths due to COVID-19 during the first year of the vaccination campaign[1]. The COVID-19 vaccines are safe and effective, significantly reducing the risk of serious illness and death due to COVID-19. 

Despite overwhelming evidence of the COVID-19 vaccines’ success, misinformation about these vaccines continues to spread online. Recently, a group of doctors and scientists signed a declaration where they called for a worldwide stop to the COVID-19 vaccination campaigns. The declaration also claimed that “there is an international medical crisis due to the diseases and deaths co-related to the administration of products known as ‘COVID-19 vaccines’”, and that a “high incidence of miscarriages” and a “large number of adverse side effects” were occurring in people who received the COVID-19 vaccines.

The declaration is supported by COVID-19 denialist groups that have created and spread misinformation about COVID-19 and the COVID-19 vaccines, including Médicos por La Verdad, which is active in a number of Spanish-speaking countries, and Médicos pela Vida, a Brazilian group that became famous for promoting ineffective COVID-19 treatments. Signatories of the declaration include individuals like Natalia Prego, a member of Médicos por La Verdad (whose name appears three times on the list of signatories, see here). 

Outlets like One American News Network (OAN) and Daily Sceptic, two websites that have been previously factchecked by Health Feedback, reported on the declaration. Neither outlet acknowledged that the claims made in the declaration were previously fact-checked and found to be inaccurate, unsupported or misleading.

The outlets’ claim that “400 doctors” signed the declaration—likely an attempt to suggest strong support by the general medical community—is suspect. Based on multiple signatures left on the declaration (see here, here, here, here, and here), some of which include fictitious names and locations, it becomes clear that any individual can sign it and no vetting of a signatory’s qualifications is required.

The declaration made three main claims to support their statement that the COVID-19 vaccines have precipitated an “international medical crisis”. As we’ll show below, these three claims are misleading, inaccurate and unsupported.  

Claim 1 (Misleading):

We are currently witnessing an excess in mortality in those countries where the majority of the population has received the so called ‘COVID-19 vaccines’

The declaration began by claiming that there was excess mortality in countries where the majority of the population had received the COVID-19 vaccines. This isn’t a new claim. In 2022, Health Feedback and other organizations and news outlets fact-checked a number of claims about how the COVID-19 vaccines were to blame for the rise in excess deaths in 2021; fact-checks addressed claims about excess death in highly vaccinated European countries, in children in Europe, and among millennials in the U.S.

Previous fact-checks of these types of claims demonstrated that these claims are built on faulty analyses of data. For instance, in August 2022, Health Feedback pointed out that the claim that European countries with lower vaccination rates had lower excess deaths compared to countries with high vaccination rates was only true for June 2022 and only when compared to the average excess deaths for the years 2016 to 2019, which is before the COVID-19 pandemic and therefore doesn’t reflect the current COVID-19 reality. Furthermore, these claims are built on correlations that are oversimplified and don’t account for other variables—such as age distribution and healthcare capacity—that also impact mortality.

Additionally, previous fact checks also pointed out that there are many possible explanations for excess death in 2021. In a fact-check about claims about excess death among millennials, experts told the Associated Press that “COVID-19 itself is the obvious culprit for the deaths”, especially as the rise in deaths coincided with the highly-contagious Delta and Omicron variants of SARS-CoV-2. 

In a fact-check about the claims of excess death among European children, experts told the fact checking group RMIT FactLab that excess deaths in this age group could be due to COVID-19, the post-lockdown resurgence of respiratory diseases like influenza, and long-term consequences of the pandemic (postpones screenings and treatments, overloaded healthcare systems).

Finally, there’s no evidence that the COVID-19 vaccines are causing a rise in mortality. “To date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed deaths following the Janssen vaccine,” Martha Sharan, a spokesperson for the U.S. Centers for Disease Control and Prevention (CDC), told the Associated Press in March 2022.

Claim 2 (Inaccurate and Unsupported):

The large number of sudden deaths in previously healthy young people who were inoculated with these ‘vaccines’, is particularly worrying, as is the high incidence of miscarriages and perinatal deaths

The authors of the declaration tied the COVID-19 vaccines to “sudden deaths in previously healthy young people”. As with the claim about excess death, this claim was previously shared on social media and fact-checked by Health Feedback and others and found to be unsupported. Some claims specifically implied that the COVID-19 vaccines are causing Sudden Arrhythmia Death Syndrome (SADS).

Sudden deaths are unexpected, fatal events that occur within one hour of the onset of symptoms in apparently healthy individuals; the majority of sudden deaths are cardiovascular and arrhythmic in origin, meaning most of these fatal events involve the heart, blood vessels or irregular heartbeats. SADS is a form of sudden death that occurs in people under the age of 40 who, due to a genetic problem, have an abnormal heart rhythm that leaves them at a higher risk of suffering a cardiac arrest; in the U.S., about 4,000 children and young adults die from a SADS condition every year.

The claim that the COVID-19 vaccines are implicated in “the large number of sudden deaths in previously healthy young people” is factually inaccurate in two ways. First, previous fact-checks of similar claims have shown that there is no evidence that there has been a rise in sudden deaths or SADS. Second, there is also no evidence that the COVID-19 vaccines are causing sudden deaths or SADS. As such, this part of the claim is unsupported.

The declaration also linked the COVID-19 vaccines to a “high incidence of miscarriages and perinatal deaths”. The American College of Obstetricians and Gynecologists (ACOG) defines miscarriages, also called early pregnancy loss or spontaneous abortion, as the loss of a pregnancy before 13 completed weeks. The Australian Institute of Health and Welfare defines perinatal deaths as a stillbirth (fetal death prior to the birth of the baby) or neonatal death (death of a live born baby) of a baby of 20 or more completed weeks of gestation or of 400 grams or more birth weight.

This is again a common piece of misinformation about the COVID-19 vaccines that has been debunked by vaccine clinical trial data and large-scale studies which show that the COVID-19 vaccines don’t increase the rate of miscarriages and negative pregnancy outcomes. Moreover, because pregnant women are at a higher risk of developing severe COVID-19, which increases the risk of pregnancy complications, the vaccines actually reduce the risk of severe COVID-19 and of pregnancy complications. This is why medical associations like ACOG and government agencies like the CDC recommend that all pregnant women get vaccinated for COVID-19. As such, this part of the claim is inaccurate. 

Claim 3 (Misleading):

…to date there have been more than 11 million reports of adverse effects and more than 70,000 deaths co-related to the inoculation of the products known as ‘covid vaccines’

To back their claims about the COVID-19 vaccines, the declaration referred to reports from the CDC’s VAERS, the UK’s Yellow Card System, the Australian Adverse Event Monitoring System, Europe’s EudraVigilance System and the WHO’s VigiAccess Database claiming these showed over “11 million reports of adverse effects and more than 70,000 deaths”. The declaration, however, failed to acknowledge a major limitation of these adverse event reporting databases: that reports aren’t confirmed, requiring further analysis to determine if the COVID-19 vaccines caused or contributed to the event reported.

VAERS, which stands for Vaccine Adverse Event Reporting System, is a database maintained by the CDC and the U.S. Food and Drug Administration where anyone can submit a report about an adverse event following inoculation with a US-licensed vaccine. On the CDC’s About page for VAERS, a disclaimer states that “VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness”, adding that “the number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event”.

The Yellow Card scheme is run by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and it “collects and monitors information on suspected safety concerns involving a [sic] healthcare products”, including vaccines. The MHRA routinely publishes summaries of Yellow Card reporting for the COVID-19 vaccines. In a 1 September 2022 summary, the MHRA stated that “many suspected ADRs [adverse drug reactions] reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that symptoms occurred around the same time as vaccination”. Later in the same summary, the MHRA emphasized that “it is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines”.

Australia’s Therapeutic Goods Administration (TGA) evaluates and monitors the safety of therapeutic goods, including collecting reports on adverse events to medicines and medical devices. TGA maintains a Database of Adverse Event Notifications (DAEN), and on the DAEN webpage TGA makes the limitations of this data clear. Specifically, TGA notes that “adverse events are suspected of being related to a medicine or vaccine, but this relationship is usually not certain – the symptom may be related to the underlying illness or to other factors”, adding that “there might be no relationship between the adverse event and the medicine or vaccine – it may be a coincidence that the adverse event occurred when the medicine or vaccine was taken”.

EudraVigilance is a database managed by the European Medicines Agency (EMA) that collects and analyzes reports of suspected adverse reactions to medicines in the European Economic Area. Similar to other databases, EudraVigilance facilitates the early detection of suspected safety issues with drugs. EudraVigilance also includes a disclaimer stating that “the information on this website does not reflect any confirmation of a potential link between the medicine and the observed effect(s)” and that “the number of suspected side effects in EudraVigilance should not serve as a basis for determining the likelihood of a side effect occurring”.

VigiAccess is the World Health Organization’s (WHO) global database of reported suspected side effects to medicinal products, such as drugs and immunizations. As with the previously mentioned databases, the WHO makes clear that “VigiAccess cannot be used to infer any confirmed link between a suspected side effect and any specific medicine” and that the database “cannot be used to determine the likelihood of a side effect occurring”.

In short, while all five databases are important tools for monitoring vaccine safety, the existence of a report in any of these databases alone isn’t sufficient proof that the COVID-19 vaccines caused or contributed to an adverse event. Reports need to be further analyzed to determine if vaccination played a role in the adverse event. As such, the claim made by the doctors and scientists in the declaration that “there have been more than 11 million reports of adverse effects and more than 70,000 deaths co-related” to the COVID-19 vaccines is misleading, for it doesn’t consider that adverse event reports in these databases are unconfirmed.

Misinterpretation and misuse of these databases to claim that the COVID-19 vaccines are harmful have been rife since the beginning of COVID-19 vaccination campaigns. Such claims have primarily focused on VAERS, but have also been made about the Yellow Card scheme, TGA’s reporting system, EudraVigilance and VigiAccess.

Conclusion

The declaration, which as of 16 September 2022 had been signed by nearly 11,000 individuals, made a series of inaccurate, unsupported and misleading claims claims about the safety of the COVID-19 vaccines and used these to urge for a worldwide stop to COVID-19 vaccinations. In reality, the COVID-19 vaccines are safe and effective and are estimated to have prevented nearly 20 million deaths from COVID-19 in the first year of the vaccine campaign.

REFERENCES

 

Published on: 19 Sep 2022 | Editor:

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