[아이팜뉴스] The Ministry of Food and Drug Safety (Director Kang-Rip Kim) said that in consideration of the high public interest in the Corona 19 vaccine, it will continue to provide information on the safety and effectiveness of the vaccine, and strive to create an environment in which the Korean people can receive the vaccine with confidence. . We began to explain the data on the characteristics and principle of action of the Corona 19 vaccine. In addition, it announced that it plans to do its best to ensure that the public can use a safe vaccine through a thorough review and management of the safety and effectiveness of the vaccine applied for approval.
The Ministry of Food and Drug Safety said on the 7th that rapid development of the Corona 19 vaccine is being promoted worldwide, and various vaccine platform technologies are being used. These vaccine platforms include ▲viral vector vaccines ▲RNA vaccines ▲recombinant vaccines and ▲inactivated vaccines.
‘Vaccine platform’ is a basic technology for developing vaccines by changing only specific antigens or genetic information in a vaccine, and using this can greatly shorten the vaccine development period.
◆Viral vector vaccine is a vaccine that induces an immune response by injecting an antigen gene into another virus template, such as adenovirus*, which is harmless to the human body, and producing an antigenic protein in the body. Representative vaccines from AstraZeneca and Janssen (Johnson & Johnson) Vaccines are available and will be introduced in Korea.
* AstraZeneca vaccine uses adenovirus that only infects chimpanzees as a carrier.
Compared to RNA vaccines, it is relatively stable to heat, but since it uses live adenovirus, a cold chain equivalent to live vaccine (4℃) is required, and Janssen’s Ebola vaccine is the approved vaccine.
▶ AstraZeneca’s vaccine was approved for emergency use on December 30, 2020 in the UK, and the European Medicines Agency (EMA) is known to be undergoing preliminary review since October last year.
In Korea, a permit was applied (2021.1.4.) and is currently under review by the Ministry of Food and Drug Safety.
▶ The Janssen (Johnson & Johnson) vaccine is undergoing phase 3 clinical trials from September 2020, and there have been no cases of overseas approval until now.
In Korea, a preliminary review of non-clinical and quality data has been requested (2020.12.22.) and is under review.
▶ As for domestic development, the Celide vaccine is undergoing phase 1/2 clinical trials.
◆RNA vaccines inject antigen genes in the form of RNA to produce antigenic proteins in the body to stimulate immune responses.
Representative vaccines from Pfizer and Modena are expected to be introduced in Korea.
Short production period allows mass production quickly and within a short period of time, but the stability is poor because RNA, the main component of RNA degrading enzyme (RNase), is easily decomposed, so it is a cold chain of frozen ((ex) -20℃ or -75±15℃) It is necessary, and in this way, the Corona 19 vaccine was first commercialized.
* RNA (Ribonucleic acid): One of two types of nucleic acids in the nucleus of cells that mediate gene information and regulate gene expression.
Pfizer’s vaccines are currently approved for emergency use in the UK (2020.12.02.), the United States (2020.12.11.), and Canada (2020.12.09), and Switzerland (2020.12.19.) and Europe (EU). (2020.12.21.), it was granted conditionally.
The World Health Organization (WHO) has also approved emergency use (December 31, 2020) and is using Pfizer’s vaccine worldwide, which has a positive meaning that it is universally available for reference.
In Korea, a preliminary review of non-clinical and clinical data has been requested (2020.12.18.) and is under review.
Modena’s vaccine is currently approved for emergency use in the United States (December 18, 2020) and conditionally licensed in Europe (EU) (1.6. In Korea, it is before prior review and application for product permission.
Currently, as a domestically developed vaccine, a DNA vaccine in a form similar to an RNA vaccine is being developed by Genexine and Genewon Life Sciences, respectively, and clinical phase 1/2 is in progress.
* DNA (Deoxyribonucleic acid): It is one of two types of nucleic acids in the nucleus of cells that store and preserve genetic information.
◆ Recombinant vaccine is one of the most widely used vaccine platforms as it induces immune responses by directly injecting antigenic proteins made using genetic recombination technology.
Recombinant antigen protein alone may have a low immune response, so a formulation containing an adjuvant (aluminum salt, etc.) is generally required, and it is known as a highly safe vaccine due to long-term use.
Recombinant vaccines include hepatitis B vaccine and human papillomavirus vaccine (HPV (cervical cancer vaccine)).
As a Corona 19 vaccine, there is a vaccine from NovaVax, and a phase 3 clinical trial is in progress as of September 2020, and there have been no cases of overseas approval so far, and SK Bioscience vaccine is in phase 1/2 clinical trial for domestic development.
◆Inactivated vaccine is a traditional vaccine platform that induces an immune response by killing a virus and injecting it into the body as an antigen. There are a number of vaccines developed.
When securing an infectious virus, rapid development is possible, the manufacturing method is simple, and it is characterized by excellent induction of neutralizing antibodies, but for the corona 19 virus, a BL3 class* production facility is required.
* Biosafety level (BL): This refers to the level of shielding required to safely handle infectious pathogens and is classified from BL1 to BL4 according to the risk level.
Examples of inactivated vaccines include hepatitis A vaccine, polio vaccine for injection, and death vaccine for Japanese encephalitis.
There is a vaccine from China’s Sinopharm as a corona 19 vaccine, and it was approved in China on July 22, 2020.
In addition, according to the WHO (COVID-19 Candidate Vaccine Update), various types of Corona 19 vaccines are being developed at Kanshino (Virus Vector Vaccine) and Russia Gamalea Research Institute (Virus Vector Vaccine). * Source: WHO DRAFT landscape of COVID-19 candidate vaccines
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Reporter Lee Young-bok 48yblee
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