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The Ministry of Food and Pharmaceutical Safety announced the results of the first expert advisory group discussion on the results of the clinical trial of the AstraZeneca Corona 19 vaccine conducted the day before. The day before, the Ministry of Food and Pharmaceutical Safety held a meeting of the ‘Corona 19 Vaccine Safety and Efficacy Verification Advisory Group’ (verification advisory group) in which 8 experts participated, including specialists in infectious medicine, vaccine experts, and clinical statistics experts.
62% effective AZ vaccine … Many older people can get vaccinated
The verification advisory group said: “It showed a 62% preventive effect” regarding the effectiveness of AstraZeneca’s COVID-19 vaccine. This is a level that meets national and international standards (prevention effect of 50% or more) related to the evaluation of the effectiveness of the COVID-19 vaccine as the World Health Organization (WHO). This result was confirmed for 8,895 adults 18 years or older who tested negative for Corona 19 virus (4,440 vaccine groups, 4,455 control subjects). In the test, 27 people in the vaccine group and 71 people in the control group were confirmed as COVID-19.
The validation advisory group viewed the safety of the AstraZeneca vaccine as “acceptable”. However, for the occurrence of adverse events related to the nervous system, including transverse myelitis, a clue was attached that follow-up is necessary after permission. Transverse myelitis is a symptom associated with inflammation of the spinal cord caused by an immune-mediated reaction. During the clinical trial period, serious adverse events were reported in 0.7% of the vaccine group (79 patients) and 0.8% of the control group (89 patients). In the vaccine group, there were fever (1 case) and transverse myelitis (1 case) as serious adverse events that could not be excluded from the administration of the vaccine.
Many of the verification advisory groups commented on whether or not to restrict vaccination in the elderly interest group, that “administration to the elderly cannot be excluded simply because the number of elderly among the subjects is small.” However, there are some opinions that further confirmation of the results is necessary due to the lack of data on older people. That is why the entire verification advisory group could not conclude that it is possible to vaccinate the elderly. Kim Sang-bong, head of the Biopharmaceutical Office of the Ministry of Food and Drug Safety, said: “There is no conclusion or part that all participants agree on,” he said. “The Central Pharmacy Review Committee (Central Pharmacy Review) We will discuss again and draw a final conclusion.” The Ministry of Food and Pharmaceutical Safety will open the Central Center for Pharmaceutical Affairs on the 4th, receive a second expert advice and release the results on the same day.
A large number of advisory groups “Confirmation of the effectiveness of prevention in all subjects, including the elderly”
Many of the verification advisory groups heard that the clinical trial plan was designed to confirm efficacy and safety in subjects 18 years of age or older on the basis of ‘possible vaccination for the elderly’, and that the preventive effect is confirmed in all subjects. even over 65. Here, a binding antibody, which means the amount of antibody that binds to the Corona virus 19 antigen (99.3% for adults-100% for the elderly), and a neutralizing antibody that can induce a preventive effect by neutralizing infectivity of the virus. by binding to the surface of the virus particle (the fact that the immune response after vaccination for the elderly, such as 80.7% for adults and 64% for the elderly) was similar to that of adults it became the basis for possible vaccination for all ages.
The verification advisory group also considered that it would be appropriate to administer the AstraZeneca vaccine twice as a standard dose every 4 to 12 weeks. It means that the second standard dose is not recommended after the first low dose (half the standard dose). In particular, with regard to administration to pregnant women, he cautioned that “dosing during pregnancy is not recommended.” On the other hand, the Ministry of Food and Pharmaceutical Safety will open on the 5th the ‘Final Inspection Committee’, which is the final consultation procedure for the Corona 19 ‘Rekironaju’ treatment, and will finally decide whether to approve Rekkironaju, and the results will be will report the same day.
On the other hand, the US Pfizer vaccine, which is expected to be the first corona19 vaccine in Korea, is expected to arrive after mid-February with 117,000 doses (approximately 60,000 people) through the COVAX Facility (purchase project joint vaccine). In a regular briefing on day 1, Jung Eun-kyung, head of the quarantine countermeasures headquarters, said: “Since the quantity of Pfizer vaccines received through COVAX facilities has been confirmed, the special procedure import will proceed quickly. ” “Pfizer vaccine will be administered first from medical personnel treating confirmed patients.” The AstraZeneca vaccine through the Cobax Facility is expected to be delivered in a minimum of approximately 2.6 million doses (for approximately 1.3 million people) and a maximum of approximately 4.4 million doses (for approximately 2, 2 million people) in the first half.
