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New COVID-19 vaccine warnings don't mean it's unsafe – they mean the system to report side effects is working - Yahoo News

New COVID-19 vaccine warnings don't mean it's unsafe – they mean the system to report side effects is working - Yahoo News

New COVID-19 vaccine warnings don't mean it's unsafe – they mean the system to report side effects is working - Yahoo News
Jul 19, 2021 2 mins, 24 secs

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.

Understanding how information about adverse events is collected and what it means for vaccine safety may help people make informed decisions about their health.

After the FDA reviews phase 1 data and deems the vaccine safe enough to be studied further, the vaccine moves on to phases 2 and 3, where it will be given to larger numbers of people over longer periods of time.

The Vaccine Adverse Event Reporting System (VAERS) is a national safety monitoring system run by the FDA and Centers for Disease Control and Prevention.

While certain types of adverse events, such as injuries during vaccine administration and serious complications, are mandatory for health care providers to report, anyone can submit a report.

Recent adverse events associated with the COVID-19 vaccine, including Guillain-Barré and thrombosis for Johnson & Johnson and myocarditis for Pfizer, were identified through VAERS.

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.

For example, many of the tens of millions of people who have received the Pfizer vaccine have likely experienced a sunburn.

Second, a plausibly identified adverse event does not necessarily make the vaccine unsafe.

Administering one vaccine to a huge sample of people can make it easier to identify a possible connection between the shot and a side effect.

But there are safety nets in place to monitor the COVID-19 vaccines, and they are still working as they should.

The COVID-19 vaccines are proven to be overwhelmingly safe for most people.

Some 0.4% of participants in the J&J trial experienced serious adverse events unrelated to COVID-19 infection.

In contrast, the trial demonstrated that people who get the vaccine are 85% less likely to get severe COVID-19 than those who remain unvaccinated.

The extremely rare side effects associated with the COVID-19 vaccines were discovered because safety reporting tools were used appropriately.

The Food and Drug Administration added a warning to Johnson & Johnson's COVID-19 vaccine noting that it had been linked in extremely rare cases to an autoimmune condition known as Guillain-Barre syndrome.

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