COVID-19 vaccines approved for emergency use prevent the disease and are generally safe based on rigorous clinical trials and ongoing monitoring

CLAIM

“No one can possibly know if the [COVID-19] vaccine is safe and effective because the trial is still underway; “Thousands of people who had the vaccine have died or been seriously injured by it”

VERDICT more about the rating framework

SOURCE: Vernon Coleman, Charlie Ward, 2 Feb. 2021  

DETAILS

Misleading: The fact that a clinical trial for a COVID-19 vaccine is ongoing even after the U.S. FDA authorized it for emergency use doesn’t mean that the vaccine isn’t safe. Before approval, COVID-19 vaccines went through rigorous clinical trials to demonstrate their efficacy and safety during at least a two-month follow-up. Because 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, illnesses and deaths will occur at a certain frequency in the general population. Simply because one event occurred after another doesn’t mean that the two are causally linked. Therefore, the occurrence of adverse events and deaths following COVID-19 vaccination doesn’t necessarily mean that the vaccine caused them.

KEY TAKE AWAY

No vaccine can receive Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) unless clinical trials demonstrate that it is safe and can prevent the disease in vaccinated individuals. Data from Phase 3 trials and continued monitoring of vaccinated individuals show that the COVID-19 vaccines approved by the FDA have a high level of efficacy and are generally safe. This evidence indicates that the benefits of the COVID-19 vaccines in preventing the disease largely outweigh potential risks, such as allergic reactions in a small number of people who have previous histories of allergies.

FULL CLAIM: “No one can possibly know if the [COVID-19] vaccine is safe and effective because the trial is still underway; “Thousands of people who had the vaccine have died or been seriously injured by it”; “Legally, all those people giving vaccinations are war criminals”

The central claim of the video is that the COVID-19 vaccines currently in use weren’t proven to be safe or effective, which is inaccurate. In order to obtain Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), a vaccine candidate must undergo rigorous clinical trials to assess its safety and efficacy before it can be administered to the public. Regulatory agencies review all data collected during these trials to evaluate whether the vaccine’s benefits in protecting people against the disease are greater than the risks.

So far, the FDA approved the emergency use of two COVID-19 vaccines, one developed by Pfizer and BioNTech and the other by Moderna. The U.K. and the European Union 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 a high efficacy^[1-3]. As with any other vaccine, the approval process for COVID-19 vaccines is rigorous and transparent. The findings of the clinical trials and FDA reviews are accessible to the public (see full reports for the Pfizer-BioNTech and Moderna vaccines).

Like any treatment or medical procedure, vaccines can cause side effects in some vaccinated individuals. 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 claimed that the COVID-19 vaccines are dangerous because “the trial is still underway” and there isn’t long-term safety data. However, his argument is misleading. According to an October 2020 guideline for EUA of COVID-19 vaccines, a two-month follow-up is considered sufficient to evaluate whether the benefits of the vaccine outweigh the potential risks:

“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile.”

This specific follow-up period isn’t arbitrary. As Health Feedback explained in this earlier 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 most potential serious adverse effects that might be caused by the vaccine. However, clinical trials usually continue for two years or longer after a vaccine is approved and rolled out to gather more data about the duration of vaccine efficacy and its safety.

Even after a vaccine is approved, countries continue monitoring vaccine safety and collecting data on suspected side effects. This continued monitoring may reveal rare or very rare side effects because the vaccine rollout involves millions of people as opposed to the thousands of people that were involved in the clinical trials. One example is anaphylaxis following COVID-19 vaccination in some people who have prior histories of allergic reactions. However, evidence from clinical trials and ongoing vaccination monitoring show that COVID-19 vaccines approved for emergency use are generally safe and not associated with severe side effects.

In contrast, Coleman claimed that “thousands of people who had the vaccine have died or been seriously injured by it”. The “thousands” of adverse events attributed to COVID-19 vaccines are generally based on the number of reports made in the U.S. Vaccine Adverse Events Reporting System (VAERS). VAERS is a platform for healthcare providers and members of the public to report adverse events occurring after vaccination, serving as an early warning system for potential problems with vaccines. However, VAERS reports alone don’t demonstrate that a vaccine caused the adverse event, as Health Feedback explained in this previous review.

Specifically, Coleman repeated several claims about severe injuries and deaths wrongly attributed to COVID-19 vaccines that were previously made by others. Even without vaccination, a certain number of illnesses and deaths occur in the population. COVID-19 vaccines are administered primarily to elderly adults and people with underlying health conditions. Because these particular groups have a higher rate of adverse events than the overall population, anecdotal events that happen shortly after vaccination can give rise to misunderstandings. However, most adverse events that occur after vaccination simply aren’t associated with the vaccine but are instead the result of chance.

In light of the explanations above, Coleman’s claim that healthcare workers are administering dangerous “experimental” COVID-19 vaccines without informed consent is baseless. Although a legally effective informed consent isn’t required under EUA, the FDA does require that COVID-19 vaccine providers include a EUA Fact Sheet for recipients to help them make informed decisions about vaccination. This document is similar in purpose and content to vaccine information statements for licensed vaccines but specific to each authorized COVID-19 vaccine (see the fact sheets for BioNTech/Pfizer and Moderna COVID-19 vaccines). EUA Fact Sheet includes information about 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 obtaining further information or reporting adverse reactions.

Overall, the claim that COVID-19 vaccines aren’t safe is inaccurate. Data from Phase 3 trials and ongoing monitoring of vaccinated individuals demonstrate that COVID-19 vaccines approved for emergency use are generally safe and highly effective at protecting people from the disease. Rare adverse events may emerge when very large populations receive the vaccine. However, available evidence shows that COVID-19 vaccines are not associated with severe adverse events in the general population, and their benefits largely outweigh the potential risks. COVID-19 vaccine providers and healthcare workers must give vaccine recipients as much information as possible about the benefits and potential risks of the vaccine, contrary to Coleman’s claim.

REFERENCES

• 1 – Polack et al. 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 – Voysey et al. (2020) Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet.