New Study – mRNA Vaccines Safe

Clinical decision-making often follows a risk vs benefit model. We need to consider both the risks and benefits of medical interventions compared to other alternatives. An analytical approach would look at all the data in a qualitatively different way. The human intuitive approach is to just consider the risks of the intervention. We tend to be more risk averse than other people.

Vaccines have the best risk vs benefit ratio of any medical intervention. The benefits can be profound and multi-tiered, making one highly resistant to serious illness and reducing the risk of spread. A successful vaccine program can eliminate an infectious illness from a community and even eradicate it from the world. The risks are not zero.

Misinformation is the main cause of vaccine hesitancy, it is effective because people are risk averse. It is possible to gather massive data sets regarding most vaccines because they are a public health measure and are given to many people. It's possible to track correlations between getting vaccine and other events.

Pfizer and Moderna were the first two mRNA vaccines to be introduced. These were the first vaccines that used the new technology. They were both given emergency use authorization based on large clinical trials. The vaccines were rolled out based on this EUA before going through the full approval process because we were in the middle of a serious Pandemic. A new vaccine was being rushed into people without proper testing. The research had been completed prior to the EUA and the delay to full authorization was due to red tape. No one could ever promise zero risk, but we could make a rational risk vs benefit assessment because vaccine side effects typically emerge within 3 months. The vaccines have minimal risks.

We have the benefit of being more than a year into the vaccine program. The US alone has given more than That is what the study in the Lancet does. They look at the VAERS and v-safe reporting systems. The Vaccine Adverse Event Reporting System is a system that people use to report their vaccine side effects. V-safe is a voluntary but active monitoring system where people are sent texts and reminded to use an app to report their side effects after a vaccine dose. The summary is quick.

VAERS processed 340 522 reports: 313 499 (92·1%) were non-serious, 22 527 (6·6%) were serious (non-death), and 4496 (1·3%) were deaths. Over half of 7 914 583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose two (4 068 447 [71·7%] of 5 674 420 participants for local reactogenicity and 4 018 920 [70·8%] for systemic) than after dose one (4 644 989 [68·6%] of 6 775 515 participants for local reactogenicity and 3 573 429 [52·7%] for systemic).

There were over 300,000 reported side effects in VAERS, but the majority were mild. The side effects that were considered serious were mostly fleeting. There were no new phenomena revealed in this data. There are rare side effects of myocarditis and serious allergic reactions. The myocarditis side effect is rare and fleeting. All subjects recovered from anaphylaxis.

What about those 4,496 deaths? The anti-vaccine cranks have spread a lot of fear by assuming that the deaths were caused by the vaccine. This is only a correlation. What is the background death rate of the same population over a six month period? It would be the same. The older population had a higher mortality rate. The study did not detect any change in the mortality rate. The risk of death is not increased by the vaccines.

The data was very similar to the data found in the clinical trials used to obtain EUA. The data on myocarditis and anaphylaxis was new because they were too rare to be picked up in the initial trials. The current study did not detect any new risk signals.

This means that the vaccines are very safe. Most people can expect a day or two of uncomfortable symptoms, but they are not serious. COVID is a serious illness. Even if you are not in a vulnerable population, the risks of getting COVID are more than the risks of the vaccine. The risk vs benefit analysis is easy to understand. Get a vaccine.

• Steven Novella is an academic clinical neurologist at the Yale University School of Medicine. He is the host and producer of the popular weekly science show, The Skeptics, Guide to the Universe, and also the author of the daily neuroscience website, Neuro LogicaBlog. The Skeptics Guide to the Universe was published by Dr. Novella, as well as two courses with The Great Courses.

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