[사회]”AZ vaccine, inadequate data on effectiveness over 65 years old”… postponed judgment

[사회]”AZ vaccine, inadequate data on effectiveness over 65 years old”… postponed judgment

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[앵커]

The Ministry of Food and Drug Safety has discussed whether AstraZeneca’s COVID-19 vaccine will be given to elderly people over 65, but it has not reached a conclusion.

It was recommended to discuss at the Vaccination Specialist Committee, saying that data are insufficient to determine the effectiveness of the vaccine.

Reporter Park Hong-gu on the report.

[기자]

The Ministry of Food and Drug Safety’s Central Pharmacy Review Committee advised on the approval of the product, subject to additional submission of clinical trial results for AstraZeneca.

However, it has not been determined whether the controversial elderly 65 or older can be vaccinated.

We ordered that the precautions for use reflect the fact that there are insufficient data on the effectiveness of vaccination for persons 65 years of age or older, and that they must be carefully determined.

He then recommended that the Immunization Committee discuss this matter.

[오일환 / 중앙약사심의위원장 : 규제기관으로서 식약처는 이 백신에 대한 사용을 허가한 내용이고, 구체적인 실시 방안에 대한 구체적 계획은 예방접종에 관련된 전문가자문위원회가 결정하도록 (할 것입니다.)]

According to clinical data submitted by AstraZeneca to the Ministry of Food and Drug Safety, the proportion of the elderly aged 65 and over is 7.4%.

The Central Yak-Shim Committee explained that the current clinical results have limited data on elderly people, so the effectiveness of the vaccine cannot be verified.

However, he added that it did not find any problems in safety.

The Central Yak-Shim Committee’s decision is evaluated to have stepped back from the results of the Assurance Advisory Committee meeting that the elderly can also administer AstraZeneca.

[백순영 / 가톨릭 의대 명예교수 : 처음에는 EMA(유럽의약품청)에서 승인을 했기 때문에 큰 문제가 없어 보였는데 독일, 프랑스, 스위스, 스웨덴 이런 나라들에서 속속 승인을 보류함에 따라서 좀더 나아간 임상 데이터가 필요한 시점이기는 합니다.]

The Ministry of Food and Drug Safety is planning to open a final review committee, the final expert advisory stage, to decide whether to approve AstraZeneca vaccine.

The Korea Centers for Disease Control and Prevention announced that it would decide on the vaccination plan for the elderly through the process of its own advisory group and the Vaccination Specialized Committee along with the results of the review by the Ministry of Food and Drug Safety.

This is YTN Park Hong-gu.

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