Approve a new vaccine

Would you like to help us approve a new vaccine? To start, we recommend that you access the National Medicines Agency to learn more about your mission!

Now that you know your task and how vaccines work, let's start your research in the Biomedical Research Institute!

Dr. JAMES LIND is waiting for you in the Clinical Trials Unit; don't forget his name. We recommend that you click on this building to continue the research.

We recommend that you click on the Public Health Agency to continue your research. There you'll find a new application on the tablet! Remember the password to download it: JOHN SNOW.

You only have one stage left. We recommend that you attend the meeting with the Advisory Committee to finish your research. The meeting is in room 313; remember this number!

You have successfully approved the vaccine. Congratulations!

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You've started working in the National Medicines Agency and you have to do effectiveness, safety and quality trials for a new vaccine to decide whether to approve it for use in the population. Right now you have a meeting with the director of the Agency so that she can explain your task.

Welcome to the team, . It's a pleasure to meet you! You'll be in charge of researching whether we approve the vaccine against the virus Y, which is causing several deaths.

Consult these three resources before starting to work.

You've already consulted the three resources. Now, we'll leave them here in case you need them later.

You can consult these three resources as well as the other materials that we will provide in this briefcase, which will always be available for you.

Electronic tablet which contains a video about immunity and vaccines.

Newspaper with the latest news about the development of the Y virus vaccine.

Map which will help you plan the different stages of the process that you must follow in order to approve the vaccine.

Welcome, ! My team has identified a fragment of the Y virus, which we have called "antigen Y" that could be a good candidate for the vaccine. Now we have to prove if it is capable of activating an immune response in animals and if a substance called an adjuvant is needed in order to maximize this response.

We invite you to design the experiment to prove if antigen Y activates the generation of antibodies which protect against infection by the Y virus and to determine if it is necessary to use an adjuvant. These are the stages to follow in order to confirm it:

Click on the first stage to start the experiment.

Prepare the different versions of the vaccine and the control injection to immunize the different groups of mice in the second stage.

Very good! You've prepared the necessary vaccines. Click on the third stage to continue with the experiment.

Click on the fourth stage to finish the experiment and analyse the results.

Congratulations! You have demonstrated that the most immunogenic vaccine is the one that contains adjuvant.

With this experiment you have confirmed the effectiveness of the vaccine. My team has also conducted complementary trials with animals to determine the safest dose and we have sent them to the Agency.

Close the prospectus
Open up the prospectus
Yes
No

Welcome to the Clinical Trials Unit, . Would you be so kind as to tell us the name of the person you want to visit?

Hello . We conduct clinical trials to investigate the effectiveness and safety of vaccines in humans. To do these studies, we work with certain vaccines that have passed many quality controls and have received approval from the clinical research ethics committees.

We have researched the effectiveness and the safety of the new vaccine against the Y virus in Phase I, II and III clinical trials which include thousands of volunteers. This prospectus contains some of the results.

With all the previous information, would you approve the vaccine?

Very good! Approving the vaccine is a very good decision, as the immune response in humans is very good and the side effects are very mild and infrequent (resembling the effects of any other drug). The serious secondary effects are extremely rare.

Incorrect option! The vaccine meets the effectiveness, safety and quality standards in order to be approved. To continue with the other stages, the vaccine must be approved.

Why do you think that these types of studies are done? These studies are essential to evaluate the balance between the risks and the benefits. Thanks to the evidence that they provide, many vaccines have been approved which have helped prevent contagion from various infectious diseases, such as measles, diphtheria and whooping cough.

Get an idea of the balance between the risks and benefits of vaccination with this application that you'll find loaded in the electronic tablet.

You can proceed with the experiment now that you know more about the balance between the risks and benefits.

Network: AgenciaSP_guest
Collective
vaccination
Ring
vaccination

In the Public Health Agency we'll work with software simulations. Please, log in to the Wi-Fi network to continue.

Hello . Now we only have to investigate the vaccination strategy that we will follow. Connect to the application that we have developed to explain the basic concepts of epidemiology and decide the strategy based on scientific evidence.

¡Well done ! Now that you know the basic concepts of epidemiology, you can proceed with the experiment.

After learning all this, which vaccination strategy would you implement for the Y virus?

Correct! As the disease has occurred in isolated outbreaks, this strategy would be the most effective. Later, you can present the conclusions of your research to the Advisory Committee.

Incorrect option! It seems that ring vaccination could be the best option to stop this isolated outbreak and not have to vaccinate the entire population.

Researcher Representative of the Department of Health Industry representative Representative of the patients' associations

affirms that the new vaccine for the Y virus will be able to stop the outbreak and save many lives!

Advisory Committee Meeting

We welcome you again to the National Medicines Agency. Indicate the room number where the meeting with the Advisory Committee will take place.

The moment has arrived to present all the conclusions to the Advisory Committee and answer their questions. Continue to start the meeting.

Consult the different reports and choose the sentence that allows you to answer the following question 1 of 4.

Good answer, you can proceed with the next question.

Consult the different reports and choose the sentence that allows you to answer the following question 2 of 4.

Great, continue answering questions.

Consult the different reports and choose the sentence that allows you to answer the following question 3 of 4.

Perfect, go on with another question.

Consult the different reports and choose the sentence that allows you to answer the following question 4 of 4.

Congratulations! The meeting has been a complete success.

You have successfully approved the vaccine. Congratulations!

Hello ! I'm a researcher and I'd like to know how you've measured the immune response that the Y vaccine generates.

Answer

Hello ! I'm a researcher and I'd like to know why you claim that the vaccine is effective.

Answer

Hello ! I'm a representative from the Department of Health and I'd like to know if the vaccines are safe.

Answer

Hello ! I'm a representative from the Department of Health and I'd like to know the benefits of the vaccination for the population in general?

Answer

Hello ! I'm a representative from the Department of Health and I'd like to know if there is any type of vaccination strategy that allows you to not have to vaccinate the entire population.

Answer

Hello ! I'm an industry representative and I'd like to know if the vaccine works better when an adjuvant is added.

Answer

Hello ! I'm an industry representative and I'd like to know what are the components of the Y vaccine.

Answer

Hello ! I'm a representative of the patients' associations and some of our members cannot be vaccinated; I'm wondering if there is any way of protecting them against the Y virus.

Answer

Bear in mind this information as you will need it to access the next phase of the experiment.

To continue, you must complete all the fields of the form correctly.

If you have completed the previous stages, this information will appear on the home screen from which you can access the different stages of the experiment.

Incorrect option! The vaccine meets the effectiveness, safety and quality standards in order to be approved. To continue with the other stages, the vaccine must be approved.

Very good! Approving the vaccine is a very good decision, as the immune response in humans is very good and the side effects are very mild and infrequent (resembling the effects of any other drug). The serious secondary effects are extremely rare.

With the ELISA technique we have determined the amount of antibodies generated with the different versions of the vaccine. We have seen that the mice vaccinated with the antigen had generated protective antibodies against the Y virus, a fact which indicates a good immune response.

In the report from the Clinical Trials Unit we have seen that the vaccine against the Y virus shows high effectiveness, as 97% of the subjects to whom it has been administered have developed protective antibodies against the Y virus.

Although the vaccines can present certain secondary effect, in the vast majority of cases they are very mild and short-lived. Serious effects are extremely rare. Additionally, before reaching the population they have to pass many tests, which include thousands of volunteers, to investigate their effectiveness and safety. As such, we can say that they are one of the safest drugs that exist.

Vaccines save millions of lives and help to drastically reduce the incidence of many infectious diseases, such as smallpox, measles or diphtheria, which naturally can be fatal or cause serious harm to the people who are infected.

With a simulation we have confirmed that “ring vaccination”, which consists of quickly identifying the new cases of the disease and vaccinating everyone who has been exposed to the patient can be effective in stopping an isolated outbreak and eliminating the Y virus from a population.

With the experiment we have confirmed that the immune response has been significantly higher in the mice that had been immunized with the vaccine with adjuvant.

The Y virus vaccine is formed by the antigen, the suspension fluid, the preservatives and the adjuvant.

There are people such as newborns, the elderly, the infirm or immunosuppressed individuals who cannot be vaccinated. These people are only protected if the vaccination levels in the population are high enough to generate collective immunity. Not vaccinating yourself can weaken collective immunity and leave them unprotected against an infection.