Lee Dong-hee, head of the Korea Food and Drug Administration, and Yoo-hwan, chairman of the Central Pharmacist Review Committee (center), are presenting the results of an advisory meeting of the Central Pharmacy Review Committee for AstraZeneca’s novel coronavirus infection (Corona 19) vaccine at the Ministry of Food and Drug Safety in Cheongju, Chungcheongbuk-do on the morning of the 5th. . yunhap news
At the 2nd Advisory Committee meeting of the Ministry of Food and Drug Safety for AstraZeneca vaccine approval, a conditional authorization recommendation was made that vaccination could be given as a condition of submitting the results of additional clinical trials. However, the judgment was postponed regarding the’elderly people 65 years of age or older’ vaccination.
On the 5th, the Ministry of Food and Drug Safety announced that the AstraZeneca vaccine was “advised to be able to grant product approval on the condition of submitting the results of clinical trials currently in progress,” as a result of a meeting of the Central Pharmacy Review Committee (Central Pharmacy Review), a legal advisory body on the previous day. . It is the result that the vaccination is possible for subjects 18 years of age or older, as in the first round. In addition, it was judged appropriate to administer twice at intervals of 4 to 12 weeks at the standard dose whose effect was confirmed.
However, with regard to vaccination for the elderly over 65 years of age, which was the main issue, it was concluded that the caution that “there is not enough data on the effect and should be carefully determined” should be put in, and whether or not vaccination should be further discussed at the vaccination committee.
On the other hand, the advisory group said that the adverse cases were acceptable for the side effects of the vaccine. However, there was an opinion that monitoring is necessary after permission for the occurrence of abnormal cases related to the nervous system including’transverse myelitis’. For pregnant women, it was judged that it is not recommended to inoculate during pregnancy.
Reporter Woorim Lee [email protected]