Corona 19 Vaccine The European Union (EU) executive committee officially approved the conditional sale of a novel coronavirus infection (Corona 19) vaccine jointly developed by multinational pharmaceutical company AstraZeneca and Oxford University in the UK on the 29th of last month (local time). London AFP=Yonhap News
Amid controversy over the effect of AstraZeneca vaccine vaccination for the elderly, the Ministry of Food and Drug Safety’s verification advisory group suggested the position that “the administration to the elderly cannot be excluded only because the number of elderly people participating in the clinical trial is small.”
The Ministry of Food and Drug Safety announced the results of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting on the results of a clinical trial for AstraZeneca’s novel coronavirus infection (Corona 19) vaccine.
A number of experts in the verification advisory group said that △The clinical trial plan was designed to confirm the efficacy and safety in subjects 18 years of age or older, and △The prevention effect was confirmed in all subjects, including 65 years of age or older, △Immune response after vaccine administration in adults The opinion that administration to the elderly could not be excluded was presented only because the number of elderly persons among the participants was small when comprehensively considering the similarities with △good safety profile.
On the other hand, a few experts believed that the prevention effect was not proven due to insufficient data on the elderly, who are high-risk groups. Only 7.4% of the elderly aged 65 or older participated in the AstraZeneca vaccine clinical trial. Compared to the 22% of the elderly aged 65 or older who participated in the Pfizer vaccine, this is extremely low. Experts who presented the opposite opinion also said that the seroconversion rate in immunogenicity (the degree to which a substance causes an immune response) is not different from that of adults, but the antibody titer is lower than that of adults under 65 years of age, and the correlation between immunogenic response and preventive effect. He pointed out that it is desirable to reflect in the approval matters after confirming additional results such as clinical trials, since this has not been established.
The verification advisory group is a procedure in which the Ministry of Food and Drug Safety collects advisory opinions on clinical, non-clinical, and quality areas from 8 external experts including infectious medicine specialists, vaccine specialists, and clinical statistics specialists prior to consulting the Central Pharmacy Review Committee. The meeting took place the day before.
Jinjoo Kim reporter [email protected]
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