CLAIM
“Nobody can know if the [COVID-19] the vaccine is safe and effective because the test is still ongoing; “Thousands of people who received the vaccine died or were seriously injured by it”
DETAILS
Erroneous: The fact that a clinical trial for a COVID-19 vaccine is underway even after the US FDA has authorized it for emergency use does not mean that the vaccine is not safe. Prior to approval, COVID-19 vaccines underwent rigorous clinical tests to demonstrate their effectiveness and safety during a follow-up of at least two months. Since most adverse events occur within six weeks after vaccination, a two-month period provides sufficient evidence that COVID-19 vaccines are generally safe.
Inadequate support: Even without vaccination, diseases and deaths will occur with a certain frequency in the general population. Just because one event occurred after the other does not mean that the two are causally linked. Therefore, the occurrence of adverse events and deaths after vaccination with COVID-19 does not necessarily mean that the vaccine caused them.
LEAD FROM THE KEY
No vaccine can receive Emergency Use Authorization from the United States Food and Drug Administration (FDA) unless clinical tests demonstrate that it is safe and can prevent disease in vaccinated individuals. Data from Phase 3 studies and continuous monitoring of vaccinated individuals show that FDA-approved COVID-19 vaccines have a high level of effectiveness and are generally safe. This evidence indicates that the benefits of COVID-19 vaccines in disease prevention far outweigh potential risks, such as allergic reactions in a small number of people with a previous history of allergies.
COMPLETE COMPLAINT: “Nobody can know if the [COVID-19] the vaccine is safe and effective because the trial is still ongoing; “Thousands of people who got the vaccine died or were seriously injured by it”; “Legally, all people who give vaccines are war criminals”
REVIEW
A video claiming that the COVID-19 vaccines are dangerous and that the health professionals who administer them are “war criminals” was published on February 2, 2021. The author of the video, entitled “old man in a chair”, is Vernon Coleman, a former doctor who has publicized conspiracy theories. The video went viral on Facebook, receiving more than 29,000 interactions, according to the social media analytics tool CrowdTangle.
The central claim of the video is that the COVID-19 vaccines currently in use have not been proven safe or effective, which is inaccurate. To obtain the US Food and Drug Administration (FDA) Emergency Use Authorization (USA), a vaccine candidate must undergo rigorous clinical tests to assess its safety and effectiveness before it can be administered to the public. Regulatory agencies review all data collected during these tests to assess whether the benefits of the vaccine in protecting people from the disease outweigh the risks.
To date, the FDA has approved the emergency use of two COVID-19 vaccines, one developed by Pfizer and BioNTech and the other by Moderna. The United Kingdom and the European Union have also approved the Oxford-AstraZeneca COVID-19 vaccine. Data from Phase 3 trials in tens of thousands of participants showed that these vaccines were generally safe and protected against COVID-19 with high effectiveness[1-3]. As with any other vaccine, the approval process for COVID-19 vaccines is rigorous and transparent. Findings from FDA clinical trials and reviews are publicly accessible (see full reports on Pfizer-BioNTech and Moderna vaccines).
Like any medical treatment or procedure, vaccines can cause side effects in some vaccinated individuals. The common side effects of COVID-19 vaccines include pain at the injection site, fever, headache and fatigue. However, these side effects are generally mild and only last for a few days.
Coleman said the COVID-19 vaccines are dangerous because “the study is still ongoing” and there is no long-term safety data. However, his argument is misleading. According to an October 2020 guideline for USA on COVID-19 vaccines, a two-month follow-up is considered sufficient to assess whether the benefits of the vaccine outweigh the potential risks:
“Data from Phase 3 studies should include an average follow-up period of at least two months after the completion of the full vaccination regimen to help provide adequate information to assess the risk-benefit profile of a vaccine.”
This specific monitoring period is not arbitrary. As the Health Feedback explained in this previous review, most side effects occur within the first six weeks after vaccination. Therefore, a two-month follow-up period allows researchers and regulatory agencies to identify the most serious potential adverse effects that can be caused by the vaccine. However, clinical trials generally continue for two years or more after a vaccine is approved and implemented to gather more data on the vaccine’s duration of effectiveness and safety.
Even after a vaccine is approved, countries continue to monitor the safety of the vaccine and collect data on suspected side effects. This continuous monitoring can reveal rare or very rare side effects, because the vaccine’s launch involves millions of people, unlike the thousands of people who were involved in clinical trials. An example is anaphylaxis after vaccination with COVID-19 in some people with a previous history of allergic reactions. However, evidence from clinical trials and continuous monitoring of vaccination shows that COVID-19 vaccines approved for emergency use are generally safe and are not associated with serious side effects.
In contrast, Coleman stated that “thousands of people who received the vaccine died or were seriously injured by it”. The “thousands” of adverse events attributed to COVID-19 vaccines are generally based on the number of notifications made in the US Vaccine Adverse Event Notification System (VAERS). VAERS is a platform for healthcare professionals and members of the public to report adverse events after vaccination, serving as an early warning system for potential vaccine problems. However, VAERS reports alone do not demonstrate that a vaccine caused the adverse event, as the health feedback explained in this previous review.
Specifically, Coleman repeated several claims about serious injuries and deaths wrongly attributed to COVID-19 vaccines that were previously made by third parties. Even without vaccination, a number of diseases and deaths occur in the population. COVID-19 vaccines are administered mainly to elderly adults and people with underlying health problems. Since these specific groups have a higher rate of adverse events than the general population, anecdotal events that occur shortly after vaccination can give rise to misunderstandings. However, most adverse events that occur after vaccination are simply not associated with the vaccine, but are the result of chance.
In light of the above explanations, Coleman’s claim that healthcare professionals are administering dangerous “experimental” COVID-19 vaccines without informed consent is unfounded. Although legally effective informed consent is not required by the USA, the FDA requires suppliers of the COVID-19 vaccine to include a USA Data Sheet for recipients to help them make informed vaccination decisions. This document is similar in purpose and content to the vaccine information statements (VISs) for licensed vaccines, but is specific to each authorized COVID-19 vaccine (see BioNTech / Pfizer and Moderna COVID-19 vaccine data sheets). USA Fact Sheet includes information on whether the vaccine has full FDA approval, the known and potential risks and benefits of the vaccine, alternative COVID-19 vaccines available and the possibility of refusing vaccination. It also includes information about COVID-19 and contact details for more information or to report adverse reactions.
Overall, the claim that COVID-19 vaccines are not safe is inaccurate. Data from Phase 3 studies and continuous monitoring of vaccinated individuals demonstrate that emergency-approved COVID-19 vaccines are generally safe and highly effective in protecting people from the disease. Rare adverse events can arise when very large populations receive the vaccine. However, the available evidence shows that COVID-19 vaccines are not associated with serious adverse events in the general population and their benefits far outweigh the potential risks. COVID-19 vaccine providers and healthcare professionals should provide vaccine recipients with as much information as possible about the potential benefits and risks of the vaccine, contrary to what Coleman says.