Hundreds of millions of people worldwide have received at least one dose of the COVID-19 vaccine; their safety and effectiveness are proven; The vaccines are not experimental

CLAIM

The COVID-19 vaccines are experimental

DETAILS

Misleading: So far, the three COVID-19 vaccines used in the US have received either full FDA approval (Pfizer-BioNTech) or emergency use authorization (Moderna and Johnson & Johnson). Their safety and effectiveness in humans have been demonstrated in clinical trials prior to public use. To call them “experimental” misrepresents our knowledge of the vaccines.

TAKE THE KEY WITH YOU

Data from clinical trials as well as post-marketing surveillance conducted on millions of people show that the COVID-19 vaccines have an excellent safety profile and are highly effective in keeping people out of hospitals and dying from COVID-19.

FULL CLAIM: “It’s a brand new virus and a brand new formula and the science is always evolving, but the White House wants us to keep injecting these experimental vaccines in our arms until they get it right and figure it out? NO!”

REVIEW

Political commentator Tomi Lahren posted a tweet on January 19, 2022, claiming that the COVID-19 vaccines are experimental. The tweet received more than 1,100 interactions. A screenshot of her tweet was also published on Lahren’s Facebook page, where it received another 7,500 user interactions.

Claims that the COVID-19 vaccines are experimental and/or that vaccinated individuals are guinea pigs are not new. They were circulated in early 2020, as reported by this previous Health Feedback review. At that time, three COVID-19 vaccines (Pfizer-BioNTech, Moderna, Johnson & Johnson) were approved for use under the US Food and Drug Administration’s Emergency Authorization Program. Since then, the Pfizer-BioNTech COVID-19 vaccine received FDA approval. Still, the claim that the vaccines are experimental is proving popular, as evidenced by multiple Health Feedback reviews of the same claim in viral social media posts by figures such as another political commentator, Candace Owens, and chiropractor Benjamin Benulis.

The safety and effectiveness of COVID-19 vaccines were demonstrated in clinical trials before they received EUAs

The FDA describes the concept of an EEA as follows:

Under an EUA, the FDA may permit the emergency use of unapproved medical devices or the unapproved use of approved medical devices for the diagnosis, treatment, or prevention of serious or life-threatening diseases or conditions if certain legal criteria are met, including those listed there are none adequate, approved and available alternatives.

An EUA can only be issued when the government declares a public health emergency. This description makes it clear that the EEA is specifically designed to address serious public health threats, such as those posed by the COVID-19 pandemic, when a rapid response is required.

More importantly, a vaccine candidate being considered for the EUA must have gone through clinical trials. Specifically, the FDA requires data from Phase 1, Phase 2 and Phase 3 clinical trials that demonstrate the safety and efficacy of the vaccine before an EUA can be issued. The data is then checked by a panel of experts in vaccines and infectious diseases, which determine whether the benefits of the vaccine outweigh its risks.

The FDA made the data from the clinical trials for the Pfizer BioNTech, modern, and Johnson&Johnson Vaccines publicly available, showing that the majority of adverse events observed are mild, short-lived, and characteristic of the body’s response to vaccination. These include redness and pain at the injection site, fever or headache. Serious adverse events were extremely rare, with less than 1% of volunteers experiencing such events. Significantly, such events occurred in equal proportions in the volunteers who received the vaccine and those who did not (control group). This strongly suggests that none of the serious adverse events observed during the studies were caused by the vaccine.

Clinical trial results for the RNA vaccines manufactured by Pfizer-BioNTech and Moderna, established through Phase 2 and Phase 3 clinical trials in tens of thousands of people, will be published in scientific magazines[1,2]. Phase 1 and Phase 2 studies of the Johnson & Johnson vaccine were published in New England Journal of Medicine, showing the vaccine to be sure[3], while an interim analysis of the phase 3 studies, which is currently being carried out in tens of thousands of people, for the same vaccine also showed that the vaccine protects adults safely and effectively against serious diseases.

There are also some who claimed or implies that testing for COVID-19 vaccines is not complete as the relevant entries on ClinicalTrials.gov, a database of clinical trial records maintained by the US Library of Medicine, lists an expected completion date in 2022 or 2023. This is a misunderstanding of what the estimated completion dates listed in the database mean; A study can achieve its set goals earlier than the projected completion date, and this is indeed the case for the Pfizer-BioNTech COVID-19 vaccine, which has already received approval.

Hundreds of millions of people around the world have already received at least one dose of the COVID-19 vaccine; their safety and effectiveness are well documented

It is standard practice that vaccines continue to be monitored even after they have been approved for public health use. Post-market surveillance, which can be part of it clinical trials (Phase 4) allows regulators to monitor safety even after a drug or vaccine is on the market. Such surveillance programs allow authorities to assess safety in an even larger population than those included in clinical trials. An example of post-market surveillance is the Vaccine Adverse Event Reporting System. The FDA outlined several other postmarketing surveillance programs here.

At the time of writing, more than 9.84 billion doses of COVID-19 vaccine have been administered worldwide, with the United States contributing 530 million doses to that number. The US Centers for Disease Control and Prevention’s COVID data tracker reported January 20, 2022 that 209.8 million people in the US are fully vaccinated and that more than 80.1% of the US population 5 years and older have received at least one vaccination (see below).


Figure 1. The CDC’s COVID Data Tracker on COVID-19 immunizations in the United States. Data retrieved on January 21, 2022 from this website.

Based on data from clinical trials and post-market surveillance of millions of people around the world, we know that COVID-19 vaccines have a high level of safety. Also, COVID-19 vaccines are not associated with an increased risk of pregnancy complications[4-7] or infertility[8], two other common false claims about COVID-19 vaccines.

It’s true that researchers have discovered certain serious side effects associated with COVID-19 vaccines, such as blood clots and heart inflammation. However, studies have shown that these complications are much more likely to occur when contracting COVID-19 than when contracting vaccines[9, 10], as reported by that BBC and National Geographic. Consequently, the benefits of vaccination outweigh the risks[11, 12].

Aside from its proven safety, we also have ample evidence from millions of people in different countries showing that the vaccines are highly effective in keeping people out of hospitals and dying from COVID-19 as the data from present Our world in data illustrated below.

Figure 2. The US weekly death rate from COVID-19 (per 100,000 population) based on immunization status. diagram of Our world in data. The number of fully vaccinated people in the US is estimated at about 209.1 million.

Figure 3. The US weekly death rate from COVID-19 (per 100,000 population) based on immunization status presented as a bar chart. diagram of Our world in data.

Figure 4. England’s weekly COVID-19 death rate (per 100,000 population) based on vaccination status. diagram of Our world in data. The number of fully vaccinated people in the UK is estimated at around 48.1 million.

Figure 5. England’s monthly COVID-19 death rate (per 100,000 population) based on vaccination status, presented as a bar chart. diagram of Our world in data.

REFERENCES

Comments are closed.