COVID-19 vaccine candidates show high efficacy and a safe profile in clinical trials, contrary to claims in viral video

Key takeaway

COVID-19 vaccine candidates must pass the same safety standards as any other vaccine candidate to demonstrate their efficacy and safety before approval and public use. However, the pandemic led to the removal of many of the usual limitations that such trials face, including funding, recruitment, or bureaucratic red tape, which resulted in faster completion of safety tests. Data from Phase 3 trials that included tens of thousands of participants show that COVID-19 vaccine candidates efficiently prevent infection and are generally safe.

Reviewed content

Verdict:

Inaccurate

Claim:

“The COVID-19 pandemic is not a real medical pandemic”; “The COVID-19 vaccine is not proven safe or effective”

Verdict detail

Factually Inaccurate: COVID-19 has caused millions of infections and 1.5 million deaths in all countries and continents. Therefore, it qualifies as a pandemic.
Inaccurate: Results from clinical trials demonstrate that COVID-19 vaccine candidates, including those that use RNA technology, are generally safe. RNA from vaccines cannot integrate into human DNA nor persist long enough in human cells to cause autoimmune diseases or other chronic diseases.
Unsupported: Although antibody-dependent enhancement (ADE) is a theoretically potential side effect of a COVID-19 vaccine, no study has reported increased COVID-19 severity in vaccinated animals or humans.

See our method of evaluation

Full Claim

“The COVID-19 pandemic is not a real medical pandemic”; “The COVID-19 vaccine is not proven safe or effective”; “It is reckless and unnecessary to roll out this essentially experimental vaccines, that use a completely new mRNA technology to millions of people when there is only limited short-term safety data, no evidence that they will prevent transmission of the virus, and no long-term safety data to rule out late-onset negative effects like autoimmune diseases, infertility, and cancer”

This 7 December 2020 video shows a series of 34 clips from individuals in different countries, claiming that COVID-19 vaccines are dangerous and unnecessary because the COVID-19 pandemic is not real. First published on YouTube, the video was later removed from the platform for violating its community standards. However, the video continued to circulate widely on Facebook and Instagram, receiving more than 20,000 interactions in only a few days, according to the social media analytics tool CrowdTangle.

Although the title of the video is “Ask The Experts (Covid-19 Vaccine),” the participants are journalists, metaphysicists, dentists, naturopaths, acupuncturists, pharmacists, nurses, or doctors without a specific background in virology or epidemiology. Some of them identify themselves as members of the group World Doctors Alliance, which previously spread misinformation about the COVID-19 pandemic.

The overall claim in the video is that “the COVID-19 pandemic is not a real medical epidemic” and therefore there is no need for a dangerous “experimental vaccine.” As Health Feedback explained in a previous review, the claim that COVID-19 is not a pandemic is inaccurate. The classical definition of a pandemic is “an epidemic that has spread over several countries or continents, usually affecting a large number of people.” The World Health Organization (WHO) also takes into account the novelty of a disease in defining a pandemic, as captured in their phrase “the worldwide spread of a new disease.”

Based on this definition, the WHO officially declared on 11 March 2020 that COVID-19 was a pandemic. At that time, the novel coronavirus had already caused 118,000 cases in 114 countries, as the WHO’s director-general, Tedros Adhanom Ghebreyesus, explained at a media briefing:

“WHO has been assessing this outbreak around the clock and we are deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction. We have therefore made the assessment that COVID-19 can be characterized as a pandemic. Pandemic is not a word to use lightly or carelessly. It is a word that, if misused, can cause unreasonable fear, or unjustified acceptance that the fight is over, leading to unnecessary suffering and death.”

As of 10 December 2020, the WHO confirmed 67 million COVID-19 cases and 1.5 million deaths distributed throughout the world. Despite the implementation of public health measures, COVID-19 still represents a public health threat that continues to spread, causing significant social and economic disruptions. In these circumstances, an effective vaccine could be a critical strategy to reduce the spread of the virus and prevent future outbreaks, although it would not be a magic bullet. At the time of this review’s publication, the U.K. gave emergency use approval to the Pfizer vaccine and began vaccinating healthcare workers and nursing homes staff and residents on 8 December 2020, while the U.S. Food and Drug Administration was still evaluating whether to provide Emergency Use Authorization (EUA) to two COVID-19 vaccine candidates, one from Moderna and the other from Pfizer.

The individuals appearing in the video wrongly claim that “the COVID-19 vaccine is not proven safe or effective,” arguing that “there’s not been enough time.” This claim is misleading, as Health Feedback explained in this previous review. Contrary to what the video suggests, the record timeline in the development of COVID-19 vaccine candidates does not mean that pharmaceutical companies and regulatory agencies cut corners in the process of evaluating vaccine safety. Instead, the exceptional circumstances of the COVID-19 pandemic permitted scientists to obtain reliable data from vaccine trials in a relatively short period of time due to faster recruitment of volunteers for clinical trials and their sufficient exposure to the disease. Given COVID-19’s status as a public health emergency, scientists also received more funding and less obstruction from bureaucratic red tape relative to the development of other vaccines, thus significantly shortening the development timeline.

Although COVID-19 vaccines may cause side effects, such as aches or flu-like symptoms like fever, fatigue, sore muscles, and headaches, these only last for one or two days, are short-lived, and do not result in lasting damage. Several COVID-19 vaccine candidates demonstrated high efficacy in preventing COVID-19 during Phase 3 trials. Furthermore, researchers observed no serious vaccine-related adverse effects in the tens of thousands of people who already received them^[1-4], which far exceeds the regular number of participants in vaccine clinical trials. While it is true that COVID-19 vaccine candidates completed only a few months of the 24-month safety trial, severe adverse events generally occur within the first month after vaccination. Also, scientists will continue to monitor vaccinated individuals for any adverse events even after a vaccine has been approved.

Some video participants inaccurately claim that COVID-19 vaccines are “experimental vaccines that use a completely new mRNA technology,” and may cause late-onset negative effects such as “autoimmune diseases, infertility, and cancer.” First, many of the vaccine candidates that are the frontrunners, like the one developed by Oxford University and AstraZeneca, do not involve RNA technology but are instead based on well-established approaches. Second, the claim that RNA vaccines can cause long-term disorders is generally based on the idea that RNA from vaccines can alter a person’s DNA. As Health Feedback explained in an earlier review, scientific studies show that RNA from vaccines does not integrate into human DNA^[5,6]. Furthermore, RNA is a short-lived molecule that rapidly degrades in human cells and does not persist long enough to cause chronic disorders in individuals who receive the vaccine.

There is also no evidence that COVID-19 vaccines can cause infertility in women, a claim that Health Feedback covered in this review. This claim is based on an extremely minor resemblance between the spike protein from SARS-CoV-2, the virus that causes COVID-19, and a human protein named syncytin-1, which is crucial for forming the placenta. However, the similarities between the two proteins are so small that they can readily be found in many other human proteins. If this minute degree of similarity was sufficient to activate an immune response in women against the placenta, then researchers would have observed infertility in women who had COVID-19, an effect that has not been reported.

Finally, some individuals in the video claim that COVID-19 vaccines will cause antibody-dependent enhancement (ADE), an adverse reaction that occurs when antibodies cannot neutralize a virus but instead enhance its ability to infect cells^[7]. Although ADE is theoretically a potential side effect of a COVID-19, no study has reported an increased risk of severe COVID-19 in vaccinated animals or in participants from clinical trials, as Health Feedback explained in this previous review. However, researchers will continue to closely monitor vaccinated people to conclusively rule out ADE as a potential side effect of COVID-19 vaccines.

In summary, COVID-19 is a pandemic that has spread to every continent and country, causing millions of infections and deaths worldwide, contrary to the claims in the BrandNewTube video. Vaccine candidates, including those for COVID-19, must pass several stages of clinical trials to demonstrate a high level of safety and efficacy before being approved for public use, even in the case of emergency use. Clinical trials in thousands of people show that COVID-19 vaccine candidates, including those that use RNA technology, prevent viral infection with high efficacy and are generally safe. Therefore, the evidence does not support the claim that a COVID-19 vaccine is ineffective or causes autoimmunity, infertility, ADE, or other diseases.

READ MORE

The epidemiologist Gideon Meyerowitz-Katz, explains in this article how the process of vaccine safety testing works and the reasons behind the fast development of COVID-19 vaccine candidates.
This article by Lead Stories also debunks some of the claims included in the BrandNewTube video.

REFERENCES

• 1 – Jackson et al. (2020) An mRNA Vaccine against SARS-CoV-2 – Preliminary Report. New England Journal of Medicine.
• 2 – Anderson et al. (2020) Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults. New England Journal of Medicine.
• 3 – Walsh et al. (2020) Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. New England Journal of Medicine.
• 4 – Knoll & Wonodi. (2020) Oxford–AstraZeneca COVID-19 vaccine efficacy. The Lancet.
• 5 – Pardi et al. (2018) mRNA vaccines – a new era in vaccinology. Nature Reviews Drug Discovery.
• 6 – Schlake et al. (2012) Developing mRNA-vaccine technologies. RNA Biology.
• 7 – Arvin et al. (2020) A perspective on potential antibody-dependent enhancement of SARS-CoV-2. Nature.