|
[이데일리 노희준 함정선 기자] Experts advised that AstraZeneca’s Corona 19 vaccine should be granted a license as a condition of submitting final results reports in the future. Regarding whether the controversial vaccination limit for elderly people over 65 years old, many experts thought that the AstraZeneca vaccine could be administered to elderly people as well. However, there were some opinions with disagreeing, so the entire advisory group could not reach a conclusion.
The Ministry of Food and Drug Safety announced on the 1st the results of the discussion of the first expert advisory group on the results of the AstraZeneca Corona 19 vaccine clinical trial held the day before. The day before, the Ministry of Food and Drug Safety held a meeting of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ (verification advisory group) in which 8 experts including infectious medicine specialists, vaccine experts, and clinical statistics experts participated.
62% of AZ vaccine effectiveness…Many, elderly people can be 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 satisfies domestic and international standards (prevention effect of 50% or more) related to the evaluation of the effectiveness of the COVID-19 vaccine such as the World Health Organization (WHO). This result was confirmed for 8895 adults 18 years of age or older who were negative for the Corona 19 virus (4440 vaccine groups, 4455 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 saw AstraZeneca vaccine safety as “acceptable”. However, for the occurrence of adverse events related to the nervous system, including transverse myelitis, a clue was attached that monitoring is necessary after permission. Transverse myelitis is a symptom related to 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 vaccine administration.
Many of the verification advisory groups commented on whether or not to restrict vaccination in the elderly group of interest, that “the administration to the elderly cannot be excluded just because the number of elderly persons among the subjects is small”. However, there are some opinions that additional confirmation of results is necessary due to the lack of data on the elderly. This is the reason why the entire verification advisory group could not conclude that it is possible to inoculate the elderly. Kim Sang-bong, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said, “There is no conclusion or part that all participants agreed,” he said. “The Central Pharmacy Review Committee (Central Pharmacy Review) will discuss again and draw a final conclusion.” The Ministry of Food and Drug Safety will open the Central Pharmaceutical Affairs Center on the 4th, receive a second expert advice, and disclose the results on the same day.
A large number of advisory groups “Confirmed 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 the efficacy and safety in subjects 18 years of age or older on the basis of’possible vaccination for elderly people’, and that the preventive effect was confirmed in all subjects including 65 years of age or older. Here, a binding antibody, which means the amount of antibody that binds to the Corona 19 virus antigen (99.3% for adults-100% for the elderly), and a neutralizing antibody that can induce a preventive effect by neutralizing the 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 became the basis for’all age vaccination possible’.
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. This means that it is not recommended to administer the second standard dose after the first low dose (half the standard dose). In particular, regarding the administration of pregnant women, he advised that “dosing during pregnancy is not recommended.” On the other hand, the Ministry of Food and Drug Safety will open the’Final Inspection Committee’, which is the final consultation procedure for the Corona 19 treatment’Rekironaju’ on the 5th, and finally decide whether to approve Rekkironaju, and the results will be disclosed on the same day.
Separately, the US’ Pfizer vaccine, which is expected to become the nation’s first corona19 vaccine, is expected to arrive after mid-February with 117,000 doses (approximately 60,000 people) through COVAX Facility (vaccine joint purchase project). At a regular briefing on the 1st, Jung Eun-kyung, head of the central quarantine countermeasures headquarters, said, “Since the quantity of Pfizer vaccines received through COVAX facility has been confirmed, the special import procedure will proceed quickly.” “Pfizer vaccine will be given first from the medical staff who treat confirmed patients.” AstraZeneca vaccine through Cobax Facility is expected to be supplied at a minimum of about 2.6 million doses (for about 1.3 million people) and a maximum of about 4.4 million doses (for about 2.2 million people) in the first half.