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Preparing for a COVID-19 vaccine

Steps to ensure a safe and effective protection against the disease

You’re probably hearing more about COVID-19 vaccine. Multiple vaccines are in different stages of development. Two have shown promising results from clinical trials.

This is great news because it means protection against the disease is coming and an eventual end to the pandemic. We don’t know yet when COVID-19 vaccine will become widely available. When it does, you can be confident the vaccine is safe and effective.

Vaccines are one of the greatest success stories in public health. They protect us from diseases like measles, mumps, and seasonal flu. They’ve eradicated other diseases like smallpox and polio.

How did we get here?

Operation Warp Speed allowed for quick development of COVID-19 vaccine. Even though it’s happening quickly, experts maintain the same safety standards. During normal vaccine development, the safety trials finish then manufacturers make the vaccine. For COVID-19 vaccine, vaccine manufacturing and clinical trials are still happening at the same time. This is so the vaccine is available to the public as soon as we know it’s safe and effective. Vaccines that don’t have successful clinical trials will be destroyed.

How do I know the vaccine will be safe?

Vaccines undergo multiple clinical safety trials before manufacturers seek approval for public use. Once they collect enough information from these trials, pharmaceutical companies will go to the Food and Drug Administration (FDA) and ask for an Emergency Use Authorization (EUA).

The FDA looks at many factors when making their decision. They will only grant an EUA if they have enough information to prove the vaccine is safe and effective. To get an EUA, the known and potential benefits of a vaccine must outweigh the known and potential risks. 

After the EUA:

  • Advisory Committee on Immunization Practices (ACIP) will recommend who should receive the vaccine and the timing and dose of the vaccine. The ACIP is part of the Centers for Disease Control and Prevention, which has the final say over vaccine approval.
  • After ACIP’s recommendations, Washington, Oregon, California, Colorado and Nevada—members of the Western State Pact—will meet to independently review the safety and efficacy data for each approved vaccine.

How do we continue to monitor for safety?

The safety system around vaccines is already very strong. We  monitor vaccines for safety in multiple ways once they are available to the public. Clinical safety trials will continue to enroll new participants and study the vaccine in different populations. Studies will also continue over time so we can see how long immunity lasts.

The Vaccine Adverse Event Reporting System (VAERS) is another way we monitor for safety. This national early warning system detects concerns about vaccines. Anyone can submit a report. Healthcare providers who will give COVID-19 vaccine must commit to report adverse events to VAERS.

The Centers for Disease Control and Prevention is also working on enhanced safety monitoring programs for COVID-19 vaccine. One of them is V-SAFE. It’s a smart phone-based system to conduct health checks on people who have received the vaccine. It will help to quickly identify any adverse reactions.

Where do I go for reliable COVID-19 vaccine information?

We have information on our website for the public and providers that we continue to update. We also encourage you to talk to your healthcare provider. We know you have lots of questions about these vaccines. We are committed to be a source of accurate information for our community. Find much more at www.tpchd.org/coronavirus.

Medical Provider Holds a Syringe