Explain the phases of vaccine trials. If you are like us, dear readers, you… | by CommunicateHealth | wehearthealthalliteracy
If you are like us, dear readers, you have been eagerly following COVID-19 vaccine trials updates. But of course, any benefit from a vaccine actually depends on the people. get he. And the latest Gallup poll has the percentage of Americans who say they would at just under 60. So we have work to do on this front!
With the blazing fast development times for COVID vaccines, people may fear experts are skipping safety steps. Often times, we can stick to a simple key message to solve this problem: “Experts are testing to make sure COVID vaccines are safe. By the time doctors start giving people a COVID vaccine, it will have been tested for safety with thousands of volunteers – so we will know it is safe for the general public.
In more detailed documents, it can help define the phases of vaccine trials. You are not sure of the different steps? Don’t worry, dear readers. We are here for you with some explanations in plain language! Use this cheat sheet to explain the phases of vaccine trials:
With a brand new vaccine, researchers are starting small. They give the vaccine to dozens of people – usually 20 to 100. The key question here is: Does the vaccine safe?
Phase 1 trials also help researchers determine the right dose (amount) for the new vaccine and detect any serious side effects.
Once they know the vaccine is unlikely to cause serious side effects, the researchers step it up and give it to hundreds of people. In this intermediate step, the researchers ask: The vaccine to work?
To answer this question, phase 2 typically uses a control group – or a group that receives an older vaccine or a placebo (an injection with no vaccine at all) instead of the new vaccine. This way, researchers can be sure that the vaccine is actually working to prevent the disease.
Phase 2 also builds on what researchers learned about safety in Phase 1. Researchers are learning more about short-term side effects and continue to focus on the best dose to use.
Phase 3 is the big show – the last step before researchers seek Food and Drug Administration (FDA) approval and start offering the vaccine to the general public. So they give the vaccine to thousands of people in order to answer once and for all the 2 key questions: Is the vaccine safe and does it work?
This phase always uses a control group. Researchers compare the number of people who received the vaccine and contracted the disease to the number of does not have get vaccinated and catch the disease. And that tells them how much the vaccine can protect us!
Since Phase 3 tests the vaccine in a much larger and more diverse group of people, it also detects less common side effects and confirms that it is safe and working well for everyone.
This step occurs after the vaccine is approved by the FDA. That’s right – even after researchers answer the big questions, they continue to study the vaccine. They collect long-term data to make sure the vaccine continues to work well and to learn more about long-term side effects.
Combined phases and breaks
Sometimes when a vaccine is urgently needed, researchers can combine phases to speed up the approval process. But that doesn’t mean they are skipping important steps. It just goes to show that researchers and public health organizations have teamed up in an extraordinary effort to bring safe and effective vaccines to the people who need them as quickly as possible.
In addition, researchers can put vaccine trials on hold if there are any issues along the way (this has actually happened several times recently). And while it might sound scary, it’s a good thing. Why? It means the system works to ensure our safety.
Bottom line: Explain the phases of vaccine trials to build public confidence in the process – and in a future COVID-19 vaccine.
Tweet about it: Want to build confidence in the # COVID19 vaccine approval process? Start by explaining the testing phases in #PlainLanguage. @CommunicateHlth has advice: https://bit.ly/37vPZ6p #communicateCOVID