Can We Trust the Covid-19 Vaccines? What Phase IV Surveillance Studies Show
Scientific studies support vaccine safety, but certain individual reports don’t. Which side to trust?
A randomized controlled trial (RCT) is the gold-standard method for testing the safety and efficacy of a drug or biologic in humans. Because of RCTs, we know that the Covid-19 vaccines are safe and effective compared to the control group.
Beyond the clinical trial’s control group in the general population, however, we rely on observational studies to monitor vaccine safety and efficacy. We call this post-licensure or post-marketing surveillance. But as observational study design is inferior to RCT, can we trust that the Covid-19 vaccines are safe and effective outside of the RCTs?
As covering both vaccine safety and effectiveness are too extensive, I’ll focus on safety, especially the most commonly used mRNA and DNA vaccines.
Individual voices have raised concerns about vaccine safety. I’ll not name names here, but you most probably have heard or seen articles or videos declaring that Covid-19 vaccines are dangerous. They commonly cite the Vaccine Adverse Event Reporting System (VAERS), a surveillance system in the U.S. that relies on voluntary reporting from healthcare…
