Hi, My name is Dr. Marta Gabryelska and today I will answer the question whether the COVID-19 vaccine is safe if it was developed and approved in such a short time. This presentation was created with BioRender. Vaccine development is usually measured in decades. So having access to approved vaccines available for large scale distribution before the end of 2020 was unprecedented. However, new manufacturing platforms structure based antigen design, computational biology, protein engineering and gene synthesis have provided the tools to speed up the whole process. Additionally, global collaboration between researchers, manufacturers and distributors allowed proceeding with necessary steps side by side, not one after another, accelerating vaccine development without compromising safety and effectiveness. The earliest studies that allowed quick development of COVID-19 vaccine started already in 2002, with epidemic of SARS, followed by epidemic of MERS in 2012. Scientists knew back then that such Coronaviruses were very similar to each other and current SARS-Cov-2, can pose a threat in the future. In the meantime, the work started on new types of mRNA vaccines and six years later, these research we’re in advanced stages. So when the threat of the new Coronavirus emerged in the end of 2019, scientists were ready. Development of current vaccines was initiated when the genetic sequence of the virus became available in early January 2020 and has moved at an unprecedented speed. A phase 1 trial started in March 2020. And in September, there were more than 180 vaccines at various stages of development. First vaccine for COVID-19 was approved in USA by Food and Drug Administration in December 2020. Although it was approved in an emergency pathway, the vaccine had to undergo all normal stages of vaccine development. Most COVID-19 vaccine development activity is in North America, followed by China, Europe, and Asia and Australia. Already in April 2020, the global COVID-19 vaccine research and development landscape included 115 vaccine candidates. Novel platforms based on DNA or mRNA offer great flexibility in technological manufacturing, and potential for speed. And indeed, Moderna started clinical testing of its mRNA based vaccine just two months after the sequence identification. In February 2021, there were over 300 different vaccines being tested against COVID-19. Successful vaccination strategies have already provided significant protection against more than 30 human diseases, an extraordinary impact on human health. Initial vaccines in the early 20th century, were not regulated at all. Currently, each vaccine including recently accepted COVID-19 vaccines had to go for strictly regulated stages of development. It all starts with the laborious research and development in the laboratory. The big question to be answered is how to measure the effectiveness of the vaccine in the target populations. The use of animal models in preclinical stage can mimic human disease and establish proof of principle. In clinical phases 1-3 increasing number of volunteers are vaccinated. Phase 1 studies are focused on safety. Phase 2 concentrates on establishing a proof of concept and dose ranging and phase 3 is focusing to evaluate whether the dosing and vaccination schedule can deliver the desired impact on the clinical problem with an acceptable safety profile. Efficiency, concentration of ingredients, number of doses, time between them, side effects, are strictly monitored and reported. And only after satisfactory result, vaccine manufacturer can apply for approval and vaccine can be used upon acceptance. After that point the results of vaccinations efficiency and side effects are continued to be monitored. Although, currently COVID-19 vaccines were accepted in emergency pipeline, they had to undergo and satisfy all demands of safety and efficiency. When adverse events are recorded, evaluating whether there is any casual relationship with the vaccine administration, or wherever it is just coincidental, is vital. The risk assessment is being done and side effects are reported according to how often they are reported to occur. The side effects can be very common, occurring in more than 10% of vaccinated people, common occurring from 1 to 10% of vaccinated individuals, uncommon from 0.1 to 1%, rare from 0.01 to 0.1% of vaccinated individuals or very rare, which is happening in less than 0.01% of individuals. For example, rare blood clots after receiving Astra Zeneca vaccine are currently reported to happen in one in 100,000 vaccinated people, which is 0.001% it can be classified as a very rare event. To put things into perspective, I compared this risk to not vaccine related causes of death. In comparison to risk of dying due to car accident in India, which is also the average for the world, it is 17 times higher than the risk of developing rare blood clots. What is more, the risk of dying due to cardiovascular diseases in India is 272 times higher than developing mentioned blood clots. However, if you’re still worried about getting vaccinated, please watch our other videos about vaccinations against COVID-19. Thank you for watching with STEMcognito. Find more videos using the search box or the drop down menus above. If you think there’s something wrong with this video, please use the Report button to inform the STEMcognito team. Questions about the video content should be directed to the researcher. You can find their details below. Go to our submission pages to find out how to submit your own video and don’t forget to follow us on social media.
