VACCINE PRODUCTION

What are the vaccines that we face in our childhood, when an animal bites us, when we are cut, in short, more than once in our lives, and how do they work? With the recent introduction of Covid-19, vaccines, which we have heard more than in the past, are undoubtedly now a part of our lives. A vaccine is a medical product that enables a living being to gain immunity against other disease-causing organisms and infections. Vaccines are usually obtained by using weakened or killed versions of the viruses in question. The aim is for the treated organism to become immune and resistant to the virus by being exposed to the weakened form of the virus in advance.

But who was the first person to think of weakening a virus and injecting it into themselves? In fact, although there is no clear evidence, it is thought that vaccine-like attenuated viruses began to be used in ancient China and India as early as 200 BC. When the calendars show the year 1796, the British surgeon Edward Jenner invented the smallpox vaccine and therefore the first vaccine by using the Cowpox virus found in cows. Louis Pasteur, a French microbiologist, also made a major contribution to the development of vaccines with his rabies vaccine and many other studies.

How is a vaccine produced?

Research and Discovery Phase: 

Identification of the Pathogen:

The process starts with identifying the pathogen responsible for the disease. This can be a virus, bacteria, parasite or other microorganisms.

Preclinical Development:

Antigen Selection:

Scientists select specific antigens from the pathogen to be used in the vaccine. Antigens are parts of the pathogen that can stimulate an immune response.

Animal Experiments: 

The selected antigens are tested in animals, usually mice or monkeys. The purpose of these tests is to assess the safety of the antigens and their ability to induce an immune response.

Investigational New Drug (IND) Application:

If the preclinical results are promising, researchers file an IND application with regulatory authorities, such as the FDA (Food and Drug Administration) in the United States. This application includes data from the preclinical studies and outlines plans for clinical trials in humans.

Clinical Development:

Phase 1 Clinical Trials:

The vaccine is tested in a small group of healthy volunteers and its safety, dose and ability to induce an immune response are evaluated.

Phase 2 Clinical Trials:

The vaccine is tested in a larger group of volunteers and the safety and efficacy of the vaccine are further examined.

Phase 3 Clinical Trials:

Thousands of volunteers participate in these trials to determine the vaccine's effectiveness and monitor for rare side effects. Some participants receive the vaccine, while others receive a placebo.

Regulatory Approval:

If the results from clinical trials show that the vaccine is safe and effective, a New Drug Application (NDA) or Biologics License Application (BLA) is filed to obtain approval from regulatory authorities.

Production:

The vaccine is stored and transported in specialized containers that can be carefully manufactured to meet low quality control standards.

Distribution and Vaccination:

The vaccine is distributed to health providers and vaccination centers. Immunization campaigns are launched to vaccinate the targeted population.

Post-Marketing Surveillance:

After vaccine introduction, safety and efficacy monitoring continues. Adverse events are carefully monitored and investigated.

Global Distribution:

If the vaccine is effective and safe, efforts are made to distribute it globally, including in areas where the disease is widespread or poses a major threat.

It must be remembered that vaccines take years to produce and require many trials and approvals. So why are vaccines, including Covid-19, still controversial? Vaccines, like medicines, are medicinal products and their side effects vary from person to person, but they can cause fever, pain around the injection site and muscle aches. However, these side effects are usually mild. Some people may also be allergic to the components in the vaccine. Covid-19, on the other hand, has been much discussed because it was produced in a short period of time due to a global pandemic, before the long-term results of tests on the vaccine could be analyzed. Nevertheless, statistics show that the use of vaccines is a much more effective and accurate solution for many diseases than not using them at all.

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