[종합] AstraZeneca vaccine can be vaccinated even for the elderly… “The doctor decides carefully”

[서울=뉴스핌] Reporter Park Da-young = The Ministry of Food and Drug Safety has approved the AstraZeneca vaccine for the first time among the novel coronavirus infection (Corona 19) vaccines. While the vaccination is permitted for those aged 18 or older, the controversial elderly 65 or older can receive the vaccination.

Elderly people are determined to be vaccinated at the site under a doctor’s “careful judgment,” but the Ministry of Food and Drug Safety has not been able to come up with specific standards for this. The AstraZeneca Corona 19 vaccine will be approved for shipment by the country next week, and vaccination is expected to begin on the 25th.

The Minister of Food and Drug Safety, Kang-rip Kim, speaks at a briefing on the results of the AstraZeneca Final Inspection Committee on the 10th. [사진=식품의약품안전처]

As a result of the meeting of the final inspection committee on the 10th, the Ministry of Food and Drug Safety granted an item permission on the condition of submitting the results of additional clinical trials for the’Korea AstraZeneca Covid-19 vaccine’, a corona 19 vaccine of AstraZeneca Korea.

The Ministry of Food and Drug Safety believes that there is no problem with safety and immune response when the elderly 65 years of age or older receive this vaccine. However, it is a view that it is difficult to believe that it has a preventive effect due to the lack of clinical participants so far.

Instead, it was decided that additional clinical data should be submitted, and the precautions for use should state that’the use for the elderly over the age of 65 should be carefully decided.’ At the end of April, the results of an interim analysis of phase 3 clinical trials involving a large number of elderly people will be submitted. If the data proves effective, the precautions may be deleted and administered to the elderly.

Kim Kang-rip, head of the Ministry of Food and Drug Safety, said in a briefing on the presentation of the results of the final inspection committee meeting held at the Food and Drug Administration in Osong, North Chungcheong Province.

The criteria for vaccinating doctors to make a’careful decision’ have yet to be established. Later, the Vaccination Committee of the Korea Centers for Disease Control and Prevention will discuss vaccination standards.

Director Kim said, “It is not a situation where we can say specific standards or examples (available for vaccination),” and said, “The vaccination committee will comprehensively judge the contents discussed while reviewing the permission matters and precautions for use, and make a reasonable vaccination plan. Will establish.”

The AstraZeneca vaccine remains in the state shipment approval procedure until it is administered at the medical site after product approval.

Vaccines are items that require special attention in terms of health and hygiene and must undergo a quality inspection called national shipping approval before being distributed to the market. These include potency tests and virus particle content tests. The Ministry of Food and Drug Safety is planning to finalize the national shipment approval next week.

Normally, it takes 35 to 40 days after product approval, but for the Corona 19 vaccine, part of the national shipment approval process is also underway while reviewing the product approval in consideration of the epidemic situation.

“The national shipment approval is currently in progress, so I think it will be finalized next week. The most important thing in the approval process is safety. It will be a process of examining whether a product can be used effectively and safely in quality. “He said.

If the Ministry of Food and Drug Safety finally decides to approve the shipment in the next week, the vaccination is expected to begin on the 25th. At the back briefing of the Central Defense Countermeasures Headquarters on that day, an official from Bang Dae-bon said, “If you request how many vaccines are needed in which hospital before 24 days, we will sequentially supply the amount to the public health center.” You can start the vaccination,” he said.

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