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These extra vaccine safety steps will help keep us safe.

Vaccines are some of the safest drugs on the market. How do we know? Let’s examine some of the details of vaccine safety.

Vaccines are held to a higher safety standard because healthcare providers give them to healthy people. Vaccines prevent disease spread. Most medications treat a disease once you have it.

So, what systems are in place to monitor vaccine safety? Learn what’s standard and what’s new for the COVID-19 vaccine. We marked new safety steps with an asterisks*.

Before a vaccine hits the market.

Clinical Trials: A manufacturer must meet certain standards before it can test the vaccine in people. Vaccines go through three trial phases. As vaccines progress through clinical trial phases, the test population increases. Volunteers sign up to be a part of these trials. Researchers look to see if the vaccine is safe, effective, and if side effects occur.

FDA licensure: The U.S. Food and Drug Administration looks at all the available research on the vaccine. It can enact an Emergency Use Authorization (EUA) during a health crisis. For a vaccine to receive an EUA, the manufacturer must ensure the benefits of getting the vaccine outweigh the risks to grant an EUA. The FDA closely follows the ongoing safety data.

Advisory Committee on Immunization Practices (ACIP) review: Medical and public health experts make up the ACIP. The committee reviews all information and research on the vaccine. The ACIP makes sure the vaccine is safe and effective. If the data look good, the committee recommends who should get the vaccine. The CDC director approves and publishes the recommendations.

*Western States Scientific Safety Review Workgroup: Scientists and medical professionals from Washington state, California, Colorado, Nevada, and Oregon, review all available data from vaccine manufacturers. This extra safety review is unique to the COVID-19 vaccine. The workgroup approved the first vaccine for use Dec. 13. As the workgroup deems other vaccines as safe and effective, the states will start distributing them for use.

Ongoing monitoring.

Once a new vaccine is on the market, the safety monitoring does not stop. This is true for COVID-19 vaccines, too. There are several new and existing systems to monitor for safety and rare side effects.

Vaccine Adverse Event Reporting System (VAERS): Anyone can enter data into VAERS, including parents, patients, and healthcare providers. It collects and analyzes reports and flags patterns. VAERS and the other safety systems cross-reference data to determine if cause-and-effect relationships exist.

*National Health Safety Network: Acute and long-term care facilities report any adverse reactions to VAERS.

Vaccine Safety Datalink and Post-Licensure Rapid Immunization Safety Monitoring: These systems analyze data from healthcare organizations across the U.S. They look for adverse effects after a vaccine.

*V-SAFE: A smartphone, after-vaccination health checker. CDC sends text messages and web surveys to vaccinated people. CDC calls people reporting a significant medical adverse event.

Clinical Immunization Safety Assessment Project: CDC and seven medical research centers conduct research studies on a vaccine. These studies help clinicians answer complex questions about vaccine safety.

All these systems work together to continuously monitor for vaccine safety. They give scientists real time data to act quickly if an adverse event is detected.

Many  safety systems are constantly at work to make sure all vaccines are safe. Even more safety checks are in place for the COVID-19 vaccine than ever before.

In the meantime, do your part to control the spread of COVID-19:

Learn more about  the COVID-19 vaccine, including the Department of Health’s phased distribution plan and updates on when it will be available to more people, check out our webpage.

Close Up of Medical Provider Administering Injection in Upper Arm