COVID-19 vaccine warnings don’t mean it’s unsafe – it’s proof the system to report side effects is working

While the COVID-19 vaccines currently available in the U.S. have been proved to be safe and effective, recent reports of rare adverse events, or side effects, have raised concerns. On July 12, 2021, the Food and Drug Administration approved an update to the Johnson & Johnson COVID-19 vaccine fact sheet to include an increased risk of the rare nerve condition Guillain-Barré syndrome. This follows previous reports linking the J&J vaccine with a rare blood clot.

While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working. They also highlight how the relative risks of rare side effects like these need to be put into context…

A rare adverse event may take months or years to identify for a simple reason: It’s rare. For some drugs that are less commonly used, new safety data takes longer to discover because a relatively small number of patients use the drug…For cases like the COVID-19 vaccine, however, millions of people will receive the drug shortly after it’s released to the public, and new issues or patterns often emerge more quickly.

This can lead to two problems.

First, not every reported adverse event is directly related to the vaccine…Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe.

In such extraordinary times as during a pandemic, it’s understandable that people may be hesitant to take on any more risk than they have to. But there are safety nets in place to monitor the COVID-19 vaccines, and they are still working as they should.

Being aware of the risks of a treatment, however rare, can help people make health decisions that work best for them…And in the case of the COVID-19 vaccines, they must be weighed against the consequences of remaining unvaccinated and letting the pandemic rage on.

Emphasis added.