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Development and clinical trials of new vaccines

  The development of new vaccines is a complex and time-consuming process that begins with basic research and ends with clinical trials and registration. This process is designed to ensure that new vaccines are safe and effective.


   Exploratory phase


  The first step in the process of developing a new vaccine is the exploratory phase. This phase involves laboratory studies that help scientists understand how pathogens cause disease. Scientists can discover which pathogen molecules can trigger an immune response.

   Preclinical development phase


  The next step is the preclinical phase, which involves testing a potential vaccine on cells or animals. This phase helps scientists understand how the vaccine affects the immune system and whether it elicits the desired immune response.

  

   Clinical trial phase

 

  If a vaccine shows promising results in the preclinical phase, it moves into clinical trials, which consist of three phases:

  • Phase I is designed to evaluate the safety of the vaccine and its ability to induce an immune response. This phase usually involves a small group of volunteers (20 to 100 people).

  • Phase II focuses on evaluating the dosage, dosing regimen and method of administration of the vaccine. This phase involves a larger group of participants (from several hundred to several thousand).

  • Phase III is the final phase of clinical trials and aims to evaluate the efficacy and safety of the vaccine in large groups of people (from several thousand to tens of thousands of people).


    Registration and monitoring


    Once clinical trials are completed, the vaccine can be registered and approved for use. Once the vaccine is on the market, it continues to be monitored for safety and efficacy.


    The stages mentioned above can take many years. However, emergencies, such as the COVID-19 pandemic, can speed up the process without compromising safety, thanks to international cooperation and intensive research.


    In summary, the development of new vaccines is a process that requires careful design and rigorous testing. Each new vaccine must go through a series of meticulous steps before it is approved for use, ensuring its safety and effectiveness.





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