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Vaccine side effect comparison11/22/2023 ![]() Phase 1 typically introduces the vaccine to fewer than 100 people over several months under controlled conditions. In the first three phases, study investigators are the ones who identify, quantify and document safety issues. ![]() Vaccine clinical trials occur in four sequential phases. Every step is taken to ensure the vaccine is both safe and effective. ![]() An EUA can get a vaccine to the public more quickly by streamlining the regulatory process, but no shortcuts are taken. Regardless of whether a vaccine is approved through the typical FDA approval process or an emergency use authorisation ( EUA), the steps required to test a new drug for safety and effectiveness are the same. The FDA enforces rigorous testing and approval processes that manufacturers must follow before a new vaccine can be made available to the public. Tracking safety before, during and after approval Understanding how information about adverse events is collected and what it means for vaccine safety may help people make informed decisions about their health. They also highlight how the relative risks of rare side effects like these need to be put into context.Īs a pharmacist who has been managing operations for the University of Virginia Health System’s COVID-19 vaccine program for the past seven months, I’ve seen how uncertainty and fear over potential side effects can drive vaccine hesitancy. While reports like these can be scary, they’re a sign that the vaccine safety reporting system is working. This follows previous reports linking the J&J vaccine with a rare blood clot. ![]() 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. While the COVID-19 vaccines currently available in the US have been proved to be safe and effective, recent reports of rare adverse events, or side effects, have raised concerns. Representative photo: Hakan Nural/Unsplash ![]()
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