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The Making of the Coronavirus Vaccine

Andrea Reinhardsdóttir

Vaccines offer hope in the COVID-19 pandemic. This article analyzes the complex five-stage development process, showing an unprecedented acceleration during a global pandemic. Hold on as we reveal the scientific battle against this deadly virus from lab research to public rollout.

As scientists race to find a cure to COVID-19(Coronavirus), and with the death toll increasing every single day, many people wonder when this crisis will be over. While this is uncertain, a vaccine could be the first step in defeating this virus. 

A vaccine is a substance containing weak or dead forms of the virus. In the vaccine are microorganisms of the disease or virus in a small quantity to encourage the body to produce antibodies for the virus. The immune system will then know what to do when it comes into contact with it, which then, in turn, makes the body immune to it. However, a vaccine takes time to develop; it usually takes 10-15+ years to make a vaccine.  

Although this will not be the case for the Coronavirus vaccine, the COVID-19 vaccine will be the fastest developed. Currently, the fastest developed vaccine is for mumps, which took four years. Currently, over 135 vaccines are in the process of being developed for Coronavirus. Consequently, the U.S. believes they will have a vaccine available by early 2021. 

A vaccine has many stages of development, each one regularly taking a few years. This process will speed up for COVID-19. Stage one is the exploratory stage; this includes starting lab research to treat or prevent the disease. This stage usually takes up to one to two years. However, many researchers have already completed this stage for the Corona vaccine. 

Stage two is the pre-clinical stage; most trials never reach this stage because most do not find a good or safe treatment for the disease. The pre-clinical trial stage includes testing on animals such as monkeys and mice. The pre-clinical trial needs a sign off from the FDA to continue to the next stage.  

Stage three is clinical development; this stage includes testing in humans. The clinical development stage includes three phases, which can take up to 15 years.  The first phase of the clinical development is Phase I, Phase I involves testing the vaccine on under 100 healthy people. The second stage involves testing the vaccine on hundreds of infected people with the disease. Phase II under normal circumstances can take up to at least two years. Even so, China reached Phase II of clinical development in April 2020; they expect to complete it in July 2020. Phase III Involves testing on a couple of thousands of people. Nevertheless, Moderna, a biotech company located in Massachusetts U.S.A., plans to enter this phase as soon as July 2020, and their trials will include up to 30,000 people. As of June 15th, there are over 125 vaccines in Preclinical Phase, eight in Phase I, eight in Phase II, and two in phase III.Stage four is Regulatory review and approval; during this part, the FDA and CDC study data of the research and trials. They decide if the vaccine can be released to be utilized safely against the virus. 

The fifth stage is manufacturing, and if all is successful, the vaccine will go into production. During this part, the FDA will have to inspect the production factory and approve the drug labels. 

The last stage is Quality control; this will last as long as the vaccine is out. The government and scientists keep track of the vaccine; its progress and safety. 

Even though there are over a hundred different vaccines in development, only a few will get past these trials. A German company called CureVac expects to release its vaccine in mid-2021. Nevertheless, if their human trials go well, their vaccine could receive approval in early 2021.  

In mid-May, a Biotech Company, Serrento Therapeutics announced it has an antibody that was successful in early testing with blocking COVID-19. This antibody could prevent infections to the Coronavirus; however, it could take many months for a treatment to be released, and even longer for the vaccine. Even Oxford University is working with a company called AstraZeneca to find a vaccine. They believe it will protect the body for about a year, and they are to begin Phase 2 and 3 simultaneously in June of 2020. During an interview, the Chief Executive Officer of AstraZeneca said, “We will be ready to deliver from October if all goes well.” If this is true, then people might be safe to continue with their lives until we find a permanent vaccine to protect us from the virus in the future. If the virus does not eradicate and continues on similar to the common flu, a vaccine might become a standard for everyone to take, even newborn babies.

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