They try to discover what kinds of cells the BNV infects, how it kills those cells, and what happens to the surrounding cells.

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1 A Vaccine s Journey

2 2 A Journey From the time an idea blooms in someone s mind, to the time a nurse says give me your arm, the development of a vaccine takes10 or more years. The stages of development in the US are: Exploratory stage Pre-clinical stage Clinical development Regulatory review and approval Manufacturing Quality control

3 3 Exploratory Stage Let s say there s a virus called the Blue Nile virus (BNV). It causes high fever, severe vomiting, and, in some people, it can cause the heartbeat to slow to a dangerous level. We want a vaccine to prevent infection so that the disease is no longer a threat to humans. In the exploratory stage of vaccine development, scientists perform experiments on the virus itself, and how the virus infects and causes disease in people. This stage may last up to four years. They try to discover what kinds of cells the BNV infects, how it kills those cells, and what happens to the surrounding cells. These studies provide clues to scientists on how the virus works, and therefore how it may be stopped. For instance, if a part of the virus attaches to a part of a human cell as step one in killing the human cell, scientists may look for ways to interrupt that step maybe by targeting that part of the virus for destruction.

4 4 Pre-clinical Stage In the pre-clinical stage, tests are done based on the findings the scientists discovered while they were poking around in the exploratory stage. Let s imagine that in the first stage, scientists noted that one part of the Blue Nile virus attached to a particular part of a human cell. They believe that a vaccine could be produced to target that one part of the BNV and make it think it s attached to a human cell, so it will then assume its job is done and will stop working. Once it stops working, the virus will not be able to attach to human cells and will not cause harm. To test this idea, scientists will perform either in vitro or in vivo tests. In vitro means in glass in Latin. These tests are performed outside of a living body in a lab (for example, in a glass test tube). In vivo means in the living and these tests are performed in the living body of a plant or animal. During this pre-clinical phase, which generally lasts a couple of years, scientists are performing both in vitro and in vivo tests. The in vivo tests might be done on mammals, such as mice or monkeys, that react to the virus much like humans do. The scientists are looking to see if the candidate (trial) vaccine is basically safe and if it will do what they want it to do. In this case, that is to attach to the one part of the Blue Nile virus and deactivate it. To accomplish this, the researchers may vaccinate a mouse and then try to infect him with BNV. Most potential vaccines never make it past the pre-clinical stage.

5 5 Clinical Development When a trial vaccine seems safe and effective in animals, the next stages are studies in human volunteers. The manufacturer presents an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). In the application, the manufacturer proposes a series of studies in great detail, the process by which the vaccine will be made and tested, and includes all lab reports. All of this information is reviewed and requires approval by the FDA. The studies also get reviewed and approved by a board that represents the place where the clinical trial will be held, such as a university. Once the reviews are done, the FDA needs to approve the application before the manufacturer may start the trial. There are three phases to vaccine clinical trials in human subjects.

6 6 Phase I This phase is performed on adults usually fewer than 100 volunteers. Even if a vaccine is intended for children, the first clinical phase is performed on adults. Later testing will be on younger people, and eventually on the age group for which the vaccine is intended. The intent of this phase is to understand the vaccine s safety and to see what kind of immune response it gets.

7 7 Phase II In this phase, the vaccine is usually tested on fewer than 1,000 people. It s a randomized controlled trial with a placebo group. This means that about half of the group will receive the vaccine and half will receive a placebo (a harmless substance that s given to the individual as if it were the actual vaccine). The trial participants are randomly chosen to be in one group or the other. In this way, the scientists have no control over who gets the vaccine and who gets the placebo, so the results won t be biased. The scientists are testing: the safety of the vaccine how effective it is in causing the individual to develop immunity to the Blue Nile virus the dosage (how much should be given to an individual to achieve immunity) how often the vaccine should be given, and if it should be injected or sprayed or delivered by some other method.

8 8 Phase III This phase involves the largest number of participants, usually counted in the thousands or even tens of thousands. Phase III is a double-blind, randomized, controlled test using a placebo in one group and the vaccine in the other. When a trial is double-blind, it means that no one, not the scientists performing the trial or the individuals participating in the trial, know which group is receiving the vaccine and which is receiving the placebo. The purpose of this phase is to see how safe and effective the vaccine is. When a drug is given to a large group of people, side effects may occur that did not occur in the smaller trial groups. During this trial, scientists also test to see if the vaccine prevents infection and/or reduces the seriousness of illness if people are infected after vaccination.

9 9 Regulatory Review and Approval If phase III is a success, the next step is to submit a Biologics License application to the Food and Drug Administration (FDA). The FDA looks at several things when deciding whether or not to issue the license. They inspect the factory where the vaccine will be produced, review the vaccine s ingredients, consider the risks and benefits of the vaccine, go over all of the reports from the trials, and even approve the labeling. An external advisory board also reviews this information and makes recommendations to the FDA. Once the vaccine and the manufacturing process are approved, the vaccine can go into production. The FDA continues to keep an eye on the process. Periodically, inspections are made of the factory, and vaccine samples are tested for strength, purity, and safety. The FDA and other groups also carefully monitor the safety of the new vaccine after it is licensed and recommended for use in order to identify any safety problems that were not apparent in the clinical trials.

10 10 Manufacturing Way before a vaccine reaches the approval stage, or even phase III of the clinical trial phase, a manufacturing facility has to be identified or built. Once a vaccine is approved, millions of doses are required, and that takes a lot of space and equipment to produce. In addition to making the vaccine in huge quantities, the vaccine also has to be properly stored, shipped, and delivered to clinics and pharmacies and other end users. Healthcare professionals and the public have to be educated on the need for the vaccine, who should receive it, and how it works.

11 11 Quality Control After the vaccine is released and in use, its safety continues to be monitored by the FDA and others. In addition to outside monitoring, manufacturers may choose to conduct Phase IV trials to study the effect of the vaccine on various populations, and to see if there are any long-term side effects associated with the vaccine. The Vaccine Adverse Event Reporting System (VAERS) was set up as a way for any individual to report an adverse event (fever, soreness, chest pains, or any other event) that occurs after vaccination. It doesn t matter if the person believes the event happened because of the vaccination or was unrelated to the vaccination, they re encouraged to report an event that happens after vaccination. This broad reporting allows the Centers for Disease Control and Prevention (CDC) and the FDA to pick up on potential side effects of a vaccine, risk factors for certain populations, or issues with certain vaccine lots or batches. It also allows them to closely track new vaccines for any safety issues that might occur. The Vaccine Safety Datalink (VSD) is a large, linked database of confidential patient information that was developed by CDC and several managed care organizations. While keeping patient information safe, this database allows the VSD team to check millions of patients records for any health problems that might be associated with vaccinations. The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program is a large, linked database of confidential patient information run by the FDA, several large health insurance companies, and 10 state immunization registries. PRISM contains information on about 40 million patients, and, like the VSD, is used to study whether any health problems are associated with vaccination. Other large, linked databases of confidential patient information are run by the Centers for Medicare and Medicaid Services, Indian Health Services, Department of Defense, and Department of Veterans Affairs. These secure databases provide specially qualified research teams with information on tens of millions of people in special populations (elderly, Native Americans, military personnel, veterans) and are used to study whether any health problems are associated with vaccination. Rapid Cycle Analysis, a program of the VSD and used by these other systems, can look at real-time data to see if the adverse events in vaccinated people are the same as the adverse events among unvaccinated people. It s a valuable tool when tracking new vaccines.

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