On December 29, last year, Navy Sergeant John London was vaccinated against a new coronavirus infection (Corona 19) at Brian D Allgood Army Hospital in Pyeongtaek Camp Humphreys. The U.S. military in Korea began vaccinating the Corona 19 vaccine’Modena’ for essential personnel such as medical staff from this day.
AstraZeneca submitted review data such as the results of a vaccine clinical trial for a novel coronavirus infection (Corona 19) to the government, and the government initiated the approval and review process. In Korea, vaccination is expected to begin at the end of February.
On the 4th, the Ministry of Food and Drug Safety said, “AstraZeneca Corona 19 Vaccine (codename AZD1222) has received an application for product approval, and the approval and review work has begun.”
“The vaccine that AstraZeneca applied for permission is a viral vector vaccine manufactured by putting the corona 19 virus surface antigen gene into a chimpanzee adenovirus template. The viral vector vaccine is another viral gene used as a delivery vehicle.” AstraZeneca vaccine is manufactured by inserting a virus antigen gene that causes an infectious disease into human cells and mass-producing it. AstraZeneca vaccine uses adenovirus that only infects chimpanzees as a delivery vehicle to deliver the corona 19 virus surface antigen gene into human cells, and the delivered corona antigen gene It synthesizes antigenic proteins in the body and induces the production of neutralizing antibodies, which neutralizes and removes when the Corona 19 virus invades.”
How to make a corona vaccine. Graphic = Reporter [email protected]
There is a Janssen (Johnson & Johnson) vaccine in the United States as a COVID-19 vaccine developed using the virus vector method. The only vaccine made in this way and currently in use is the Ebola virus vaccine. It is not a traditional vaccine. According to the Ministry of Food and Drug Safety, the expected recipients are 18 years of age or older, and will be administered twice 4 to 12 weeks after one vaccination. This is the same as the usage and dosage approved for emergency use in the UK and the storage conditions are 2~8℃.
Most of the COVID-19 vaccines in the world are still under development. Based on the results of the phase 3 test, which is the last stage of the clinical trial, the vaccine is given for temporary use. AstraZeneca is currently conducting phase 3 clinical trials in 10 countries including the UK, Brazil and the US. Clinical trials were conducted on healthy people over 18 years of age, and among them, those over 65 in the UK and Brazil were included. “The clinical trial was suspended on September 6 last year due to the occurrence of an unexpected serious abnormality and transverse myelitis during the clinical trial,” said Kim, the director of the Ministry of Food and Drug Safety. In September, in the US, clinical trials resumed in October.”
The UK confirmed the preventive effect on 11,636 people in the AstraZeneca vaccine clinical trial and approved it for emergency use on December 30 last year. The vaccination is scheduled from the 4th (local time). In addition, the European Medicines Agency has been conducting preliminary reviews since October last year. The World Health Organization (WHO) has also applied for the list of drugs for emergency use, and the global vaccine supply procedure is also underway.
Unlike the clinical evaluation of general medicines that show therapeutic effects, it is important to evaluate the effectiveness of vaccines to prevent infection after vaccination in healthy people. The prophylactic effect in clinical trials is calculated based on the proportion of infected individuals who developed each after vaccination in the vaccination group and placebo (fake drug) vaccination group. For example, in a phase 3 clinical trial in which 10,000 people each vaccinated and placebo vaccinated, 10 confirmed cases out of the vaccinated group and 100 confirmed cases out of the placebo vaccinated group occurred, the probability of the vaccinated group becoming infected is the placebo group. Compared to, it is 1/10, so the effect of preventing Corona 19 infection is calculated as 90%. WHO recommends that the standard of preventive effect of the corona 19 vaccine be at least 50% in considerations when evaluating the corona 19 vaccine. The average effectiveness of the AstraZeneca vaccine is 70.4%, slightly inferior to Pfizer (95%) and Modena (94.5%). The advantage is that the price is low and the distribution and storage are convenient.
The government has concluded a vaccine contract with AstraZeneca, a vaccine developer for the novel coronavirus infection (Corona 19). yunhap news
Director Kim said, “We aim to shorten the existing processing period (180 days or more) by forming a dedicated team for expedited screening and process it within 40 days. In addition, the national shipment approval, which takes 2-3 months, will be shortened to about 20 days.” Director Kim said, “Even a day, we are trying to quickly decide whether to grant permission. The timing of the vaccine introduction or the vaccination plan is not in the area of the Ministry of Food and Drug Safety, and I cannot tell you, but the approval work will be completed by mid-February.”
The AstraZeneca vaccine is expected to be the first of the four vaccines scheduled to be introduced in Korea in the first quarter of next year. A total of 10 million people will be introduced sequentially from February. The key is when and how many vaccines come in. Since the inoculation should be done twice every 4-12 weeks, a smaller initial dose will affect the overall inoculation plan.
Jung Eun-kyung, head of the Central Defense Countermeasures Headquarters, said, “Currently, in the case of AstraZeneca vaccine, we are currently setting a supply schedule to receive the initial supply in the first quarter. In addition, we are negotiating to receive the products produced by SK Bioscience for the first quantity of the initial quantity. “Since the production is already in progress at SK Bio, there will be no difficulty in receiving the initial quantity. Discussions with the headquarters are ongoing for such a more confirmed schedule. “For 10 million people and 20 million doses (ash), which we decided to supply to Korea, we requested that we receive products produced in Korea if possible.”
General Manager Jung said, “At the end of February, vaccine vaccination for Corona 19 will begin in Korea. The first goal of vaccination, starting in February, is to maintain the health care system and to prevent death or severe illness in high-risk groups. From the end of February, vaccinations are scheduled to begin with workers in high-risk medical institutions, living in groups such as nursing hospitals and nursing facilities, and seniors living in group facilities. We are working on identifying the list and preparing in advance.”
Reporter Esther [email protected]