Prichep says creating a vaccine expeditiously, without appropriate testing, could put healthy people at risk. "One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person," Prichep said.
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Traditionally, a vaccine for any disease is developed in four stages. In the first phase, a study is done on healthy people to evaluate the vaccine for safety and immune response. For COVID-19 trial, this would typically take one to two years. In the second stage, a study will be done on hundreds of random people. This will further evaluate the safety, assesses the efficacy and informs optimal dose and vaccine schedule. Typically, this would take two to three years. In the third phase, another randomised, placebo-controlled study of thousands of people to evaluate safety and efficacy. This will take two to four years to reach any conclusion. After this, a government body approves new vaccines reviews the trial data and other information in the licensing application. In the fourth phase, post-approval studies happen that monitor effectiveness in real-world conditions.
However, for COVID-19 vaccine, medical scientists are shaving several years from traditional vaccine development timelines. They are using the full genetic sequence of SARS-Cov2, the virus that causes COVID-19, to develop vaccines that will contain a small amount of genetic code. The human body cells will take up this genetic information and produce elements of the virus, not infecting the person but triggering the immune system to respond.
To create a coronavirus vaccine, scientists are creating DNA or RNA based vaccines that can be produced in the lab. This approach is faster and more reliable than traditional vaccine processing, which uses viruses grown in eggs or cell cultures. Gingko Bioworks has committed the capacity to manufacturing DNA or RNA based vaccines.
The innovative approach, applied for this vaccine, could change how scientists develop future ones. The discovery of COVID-19 vaccine could make production more reliable and vaccines potentially more cost effective. The Coalition for Epidemic Preparedness Innovations ( CEPI) has made an urgent call for $2 billion in funding to support coronavirus's vaccine development, trials and enhanced manufacturing capacity.
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