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A vaccine must be proven to be safe and effective for humans before it can be distributed into the patient population. A step-by-step clinical trial process must be followed which starts with animal testing then moves to human testing with phases which gradually increase the number of subjects. Each phase moves towards proving safety and efficacy of the vaccine. Here are the phases of the Clinical Trial Process: Pre-clinical. Animals are used as subjects during this phase. The animal is given the vaccine and monitored for adverse events (AE). An AE is an undesirable side effect of the treatment that includes nausea, rash, headaches or even death. Death would be considered a Serious Adverse Event (SAE). All SAEs must be immediately reported to the FDA for decision whether the trial can continue. We want the vaccine to be safe and have low or no toxicity. After safety is established with the animals, we move on to efficacy. Efficacy is the effectiveness of the treatment answering the question: Does the vaccine work? The animal will be given or challenged with live virus and monitored to determine whether the symptoms of the virus appear. If the subjects show minimal AE's, no SAE's and the viral symptoms do not appear in 50% of the subjects, the FDA will allow the process to move forward into human trials. Phase I. A small sample of human subjects (30 to 50) participate in this phase. The purpose, as always, is safety and efficacy. The subjects are given a dose of the vaccine and monitored for AE's. The subjects resume their normal lives and are monitored for virus symptoms. For ethical reasons, humans are never challenged with live virus. If the subjects show minimal AE's, no SAE's and the viral symptoms do not appear in 50% of the subjects, the FDA will allow the process to move forward to Phase II. Phase II. A sample of 200 to 400 human subjects participate in this phase. Phase II will determine the best dose along with safety and efficacy. To determine best dose, patients start by getting small amounts of the vaccine, then the dose is slowly increased as new patients enter the trial. The dose can be increased by giving more at one time or by giving the same dose more often. Since larger numbers of patients receive the vaccine, there is more chance to observe unusual side effects. The best dose would be the safest dose with maximum efficacy. If the subjects show minimal AE's, no SAE's and the viral symptoms do not appear in 50% of the subjects, the FDA will allow the process to move forward to Phase III. The resulting best dose will be used in the Phase III trial. Phase III. A large sample of 3000-5000 human subjects will test the vaccine to answer the final question: Does it Work? Since larger numbers of patients receive the vaccine, there is more chance to observe unusual side effects. If an SAE occurred in the vaccine treatment arm, then an immediate report to the FDA must be made where they will determine whether the trial can continue. Clinical Trial data is collected during each monitoring visit where the patient is tested for the virus and possible side effects. If the vaccine treatment outperforms placebo by 80% or better by stopping the occurrence of the virus, then it is time to submit a New Drug Application (NDA) to the FDA. A New Drug Application (NDA) is submitted to the FDA to obtain your license to treat patients in the general public with your vaccine. You must submit all your trial information which demonstrates that your vaccine actually worked. The FDA will evaluate the results and come back with an answer of approved or disapproved. If approved, congratulations! You may treat patients and sell your vaccine! Phase IV trials are done after a drug has been shown to work and has been granted a license. Patients are monitored for AEs, SAEs and continued efficacy during large scale use. If the vaccine proves to be unsafe with large scale use, the FDA could withdraw the license to treat patients.

A vaccine must be proven to be safe and effective for humans before it can be distributed into the patient population. A step-by-step clinical trial process must be followed which starts with animal testing then moves to human testing with phases which gradually increase the number of subjects. Each phase moves towards proving safety and efficacy of the vaccine. Here are the phases of the Clinical Trial Process:

Pre-clinical. Animals are used as subjects during this phase. The animal is given the vaccine and monitored for adverse events (AE). An AE is an undesirable side effect of the treatment that includes nausea, rash, headaches or even death. Death would be considered a Serious Adverse Event (SAE). All SAEs must be immediately reported to the FDA for decision whether the trial can continue. We want the vaccine to be safe and have low or no toxicity. After safety is established with the animals, we move on to efficacy. Efficacy is the effectiveness of the treatment answering the question: Does the vaccine work? The animal will be given or challenged with live virus and monitored to determine whether the symptoms of the virus appear. If the subjects show minimal AE's, no SAE's and the viral symptoms do not appear in 50% of the subjects, the FDA will allow the process to move forward into human trials.

Phase I. A small sample of human subjects (30 to 50) participate in this phase. The purpose, as always, is safety and efficacy. The subjects are given a dose of the vaccine and monitored for AE's. The subjects resume their normal lives and are monitored for virus symptoms. For ethical reasons, humans are never challenged with live virus. If the subjects show minimal AE's, no SAE's and the viral symptoms do not appear in 50% of the subjects, the FDA will allow the process to move forward to Phase II.

Phase II. A sample of 200 to 400 human subjects participate in this phase. Phase II will determine the best dose along with safety and efficacy. To determine best dose, patients start by getting small amounts of the vaccine, then the dose is slowly increased as new patients enter the trial. The dose can be increased by giving more at one time or by giving the same dose more often. Since larger numbers of patients receive the vaccine, there is more chance to observe unusual side effects. The best dose would be the safest dose with maximum efficacy. If the subjects show minimal AE's, no SAE's and the viral symptoms do not appear in 50% of the subjects, the FDA will allow the process to move forward to Phase III. The resulting best dose will be used in the Phase III trial.

Phase III. A large sample of 3000-5000 human subjects will test the vaccine to answer the final question: Does it Work? Since larger numbers of patients receive the vaccine, there is more chance to observe unusual side effects. If an SAE occurred in the vaccine treatment arm, then an immediate report to the FDA must be made where they will determine whether the trial can continue. Clinical Trial data is collected during each monitoring visit where the patient is tested for the virus and possible side effects. If the vaccine treatment outperforms placebo by 80% or better by stopping the occurrence of the virus, then it is time to submit a New Drug Application (NDA) to the FDA.

A New Drug Application (NDA) is submitted to the FDA to obtain your license to treat patients in the general public with your vaccine. You must submit all your trial information which demonstrates that your vaccine actually worked. The FDA will evaluate the results and come back with an answer of approved or disapproved. If approved, congratulations! You may treat patients and sell your vaccine!

Phase IV trials are done after a drug has been shown to work and has been granted a license. Patients are monitored for AEs, SAEs and continued efficacy during large scale use. If the vaccine proves to be unsafe with large scale use, the FDA could withdraw the license to treat patients.

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