First expert for approval of AstraZeneca on the 31st… Results released on the 1st: Dong-A Science

Ministry of Food and Drug Safety

Courtesy of AstraZeneca

AstraZeneca vaccine. Courtesy of AstraZeneca

On the 31st of this month, the Ministry of Food and Drug Safety will hold the first expert advisory meeting for permission to use the AstraZeneca vaccine, which is expected to be introduced in Korea. In order to obtain permission for use of a novel coronavirus infection (COVID-19, Corona 19) vaccine from the Ministry of Food and Drug Safety, a total of .3 expert consultations, including the Verification Advisory Group, the Central Pharmacy Review Committee, and the Final Inspection Committee, are required. Is held today. The results of the meeting will be released on February 1.

At the verification advisory meeting, clinical experts focused on infectious medicine will participate to discuss the safety and effectiveness of AstraZeneca vaccine, clinical significance, and appropriateness of target patients. There is a controversy that AstraZeneca vaccine is lacking in clinical trial data on the efficacy of the elderly over 65 years of age, and this is expected to be reviewed in particular.

On the 28th (local time), the vaccination committee under the Robert Koch Institute (RKI), which is currently the German disease control agency, recommended that the AstraZeneca vaccine be given only to those aged 18 to 64 years old. On the other hand, the European Medicines Agency (EMA) approved vaccinations to the elderly over the age of 65 on the 29th, and accordingly, the European Union’s executive committee launched a’conditional sale’ that allowed the AstraZeneca vaccine to be sold to 27 member states for one year. Approved.

If the Ministry of Food and Drug Safety limits the age of AstraZeneca vaccine to 18 to 64 years old, the government may have to revise the vaccination plan announced on the 28th of this month. According to the vaccination plan, 8.5 million elderly people over the age of 65 can be vaccinated from May. Currently, Janssen and Modena vaccines are expected to be introduced in the second quarter (April-June) and Pfizer vaccines in the third quarter (July-September).

In an interview with the Dong-A Ilbo on the 29th, an official from the quarantine authorities said, “We are reviewing everything from the United Kingdom, which is already vaccinating, Germany, which recommended vaccinations for only 18 to 64 years old, EMA, and the World Health Organization (WHO). “We are not ruling out the possibility of making the same decision.”

Korea has signed a vaccine purchase contract with AstraZeneca for 10 million people, and plans to introduce some of them in February. The health authorities believe that AstraZeneca vaccine can be stored and distributed at about 2 to 8 degrees Celsius, and the supply and demand will not have any abnormality at the moment, as it plans to receive a vaccine that has contracted with SK Bioscience, a domestic company, to produce it.

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