Hundreds of millions of people worldwide have received at least one dose of COVID-19 vaccine; their safety and effectiveness are established; the vaccines aren't experimental - Health Feedback

Claims that the COVID-19 vaccines are experimental and/or that vaccinated people are guinea pigs aren’t new.

At that time, three COVID-19 vaccines (Pfizer-BioNTech, Moderna, Johnson & Johnson) were authorized for use under the U.S.

Since then, the Pfizer-BioNTech COVID-19 vaccine received FDA approval.

More importantly, a vaccine candidate being considered for the EUA must have undergone 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 are then reviewed by a panel of experts in vaccines and infectious diseases who determine whether the benefits of the vaccine outweigh its risks.

The FDA made the data from the clinical trials for the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines publicly available, which showed that the majority of observed adverse events are mild, short-lived, and characteristic of the body’s reaction to vaccination.

The results of the clinical trials for the RNA vaccines produced by Pfizer-BioNTech and Moderna, and established by Phase 2 and 3 clinical trials in tens of thousands of people, are published in scientific journals[1,2].

Phase 1 and 2 trials of the Johnson & Johnson vaccine were published in the New England Journal of Medicine, showing the vaccine to be safe[3], while an interim analysis of the Phase 3 trials, currently underway in tens of thousands of people, for the same vaccine also showed that the vaccine is safe and effective at protecting adults from severe disease.

There are also some who claimed or implied that testing for COVID-19 vaccines aren’t completed, because the relevant entries on ClinicalTrials.gov, a database of clinical trial records run by the U.S.

This is a misunderstanding of what estimated completion dates listed in the database mean; a trial can achieve its set goals earlier than the projected completion date, and this is in fact the case for the Pfizer-BioNTech COVID-19 vaccine, which already received approval.

Post-marketing surveillance, which can be a part of clinical trials (Phase 4), allows regulatory agencies to monitor safety even after a drug or vaccine has reached the market.

Based on data from clinical trials and post-marketing surveillance of millions of people around the world, we know that COVID-19 vaccines demonstrate a high level of safety.

Apart from its established safety, we also have plenty of evidence in millions of people in different countries establishing that the vaccines are highly effective at keeping people out of hospitals and dying from COVID-19, as data presented by Our World in Data illustrates below.

COVID-19 weekly mortality rate (per 100,000 people) based on vaccination status.

COVID-19 weekly mortality rate (per 100,000 people) based on vaccination status, represented as a bar chart.

England’s COVID-19 weekly mortality rate (per 100,000 people) based on vaccination status.

England’s COVID-19 monthly mortality rate (per 100,000 people) based on vaccination status, represented as a bar chart