KFDA verification advisory meeting including external experts
Disclosure of advisory results on February 1
Interest in recognizing the effects of the elderly
Reporter Song Yeon-ju = The first external expert advisory meeting for the approval of the AstraZeneca Corona 19 vaccine will be held today as a closed meeting.
On the afternoon of the 31st, the Ministry of Food and Drug Safety met with the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting to evaluate the effectiveness and safety of the Corona 19 vaccine (product name’AstraZenecacovid-19 vaccine’) applied for approval by AstraZeneca Korea. Open.
The results of the meeting will be announced on February 1.
The Ministry of Food and Drug Safety has prepared a’triple consultation with external experts’ procedure to verify the vaccine and treatment for Corona 19. In the past, if only the advice of the ▲Central Pharmacy Review Committee (Central Pharmacy Review), the legal advisory body of the Ministry of Food and Drug Safety, has been consulted, for corona-related drugs, ▲safety/effectiveness verification advisory group and ▲final inspection committee.
This meeting is the first step of the verification advisory meeting.
The part of interest is whether or not the effect is recognized for the elderly. It is pointed out that the number of participants in the clinical trial of this vaccine is insufficient, so the Ministry of Food and Drug Safety is also analyzing the efficacy and safety in the elderly over 65 years of age.
On the 28th (local time), the vaccination committee under the Robert Koch Institute (RKI), which is a German disease control agency, recommended vaccination only for those under the age of 65. In contrast, in December last year, the UK approved that the vaccination was possible regardless of age.
In addition, the European Commission (EU) officially approved the conditional sale of the vaccine on the 29th (local time). Earlier that day, the European Medicines Agency (EMA) recommended the conditional marketing approval of the vaccine to targets 18 years of age or older. EMA said that it was found to be safe and effective in preventing over 18 years of age when combined with clinical trial results. Most of the clinical participants are 18 to 55 years old, and although there are still no sufficient clinical results for the effects of the elderly, he mentioned that it is expected to be effective in the elderly according to the precedent of other vaccines.
In a press release on the 30th, the Ministry of Food and Drug Safety said, “It is not currently decided or direction has been decided on whether to vaccination for the elderly over the age of 65.” “Corona 19 Vaccine Safety and Effectiveness Verification Advisory Committee held on the 31st for AstraZeneca Vaccine ‘We plan to thoroughly verify through three-fold advisory meetings such as meetings.”
In a vaccination plan briefing on the 28th, Kim Sang-bong, head of the Bio-Pharmaceutical Bureau, said, “We plan to thoroughly verify the appropriateness of administration for the elderly in the context of limited clinical data for the elderly.” Do. We will check the application for European permits together.”
AstraZeneca Korea applied for permission for the first dose (0.5ml) to adults over the age of 18 and then the second dose (0.5ml) after 4-12 weeks.
Data from four clinical trials in the UK and Brazil were submitted. Based on this result, the prevention effect is reviewed. Safety will be evaluated by integrating the results of four vaccinated clinical subjects in the UK (2 cases), Brazil and South Africa.
AstraZeneca vaccine is expected to be supplied to Korea by 1.5 million people as early as next month. Vaccines received through the international joint purchase project’COVAX facility’ will also be AstraZeneca and Pfizer. The Ministry of Food and Drug Safety is aiming for approval in the second week of February.
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