Vaccine Clinical Trials

Are Vaccine Clinical Trials Safe? What You Should Know About the Process

At least four different American COVID-19 vaccinations are recruiting adult participants for Phase 3 clinical trials. The most recent of these — a trial for Janssen’s vaccine — plans to recruit up to 60,000 adults to test the vaccination’s safety and efficacy.

If you’re considering volunteering for COVID vaccine clinical trials, you may wonder about your safety. 

The good news is that the Food and Drug Administration (FDA) has placed strict regulations on clinical trials. These regulations ensure participants’ safety by requiring multiple phases and checkpoints. 

What are these phases and checkpoints, and how do they keep volunteers like you safe? We’re telling you everything you need to know about vaccine research next, so check it out. 

Phases of Vaccine Clinical Trials: Explained

Before a vaccine ever makes it to clinical trials, the FDA must approve it for pre-clinical research. This is when researchers perform studies on animal models. Pre-clinical studies must prove the safety and efficacy of the vaccine in animals.

Once a sufficient number of pre-clinical studies are complete, independent bodies must confirm that the pre-clinical studies do, in fact, give evidence that the vaccine is safe and effective. 

Phase 1 Trials

A vaccine Phase 1 clinical trial recruits small numbers of healthy patients to test the vaccine’s safety in humans. Researchers may administer the vaccine multiple times to determine an efficacious dose. 

If the vaccine is well-tolerated and produces an immune response, an Institutional Review Board (IRB) will approve the vaccine for Phase 2 trials. 

Phase 2 Trials

While Phase 1 trials only recruit 100 healthy volunteers, Phase 2 vaccine clinical trials enroll thousands of diverse subjects. Researchers investigate the efficacy of the vaccine again as well as how well it protects against the virus or pathogen it’s supposed to. 

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The results from Phase 2 trials must again go before an IRB. The IRB must agree with the researchers that the vaccine protects against the pathogen it’s supposed to before approving the vaccine for Phase 3 trials. 

Phase 3 Trials

Phase 3 trials are the last studies done before the general public can use the vaccine. These trials enroll tens of thousands of subjects in varying age groups and demographics.

The goal of a Phase 3 trial is to prove that the vaccine is significantly better at fighting its target virus than a comparator. A comparator drugs supplier provides placebos or active control drugs that the vaccine should outperform.

As long as the vaccination shows a significantly better response to the pathogen, the FDA will approve it for widespread use. 

Phase 4 Trials

Vaccine clinical trials don’t end at Phase 3. After the vaccine hits the market, researchers continue to collect information about its safety and efficacy. This is what’s known as Phase 4 of clinical trials. 

How Safe Are Clinical Trials? The Bottom Line

So, how safe are vaccine clinical trials? The FDA created the clinical trials system to ensure that vaccines are safe and effective against the pathogens they’re intended to treat.

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