Controversy over the successive efficacy of AstraZeneca vaccine… Ministry of Food and Drug Safety Disclosure of Consultation Results Tomorrow

Germany and Italy ban vaccination for senior citizens
Expected to supply 1.5 million people in Korea
Ministry of Food and Drug Safety releases consultation results tomorrow

AstraZeneca's COVID-19 vaccine.  Photo = Reuters Yonhap News

AstraZeneca’s COVID-19 vaccine. Photo = Reuters Yonhap News

Controversy about the efficacy of a novel coronavirus infection (Corona 19) vaccine jointly developed by AstraZeneca, a multinational pharmaceutical company in Europe, and Oxford University in the UK are continuing. Due to the lack of clinical research on the elderly, in Europe, vaccinations for the elderly are not permitted.

The Korean government has secured 10 million AstraZeneca vaccines. The Ministry of Food and Drug Safety held a meeting of 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 permission by AstraZeneca Korea. Opened. The results of the meeting will be announced on February 1.

The countries that have banned the AstraZeneca vaccine from vaccinating the elderly so far are Germany and Italy, and it is known that France is also considering this. The European Medicines Agency (EMA) recommended the use of the AstraZeneca vaccine on the 29th (local time), and the EU Commission accepted the recommendation and officially approved the use of the vaccine. AstraZeneca is the third Corona 19 vaccine approved for use in Italy after Pfizer-Bioentech and Modena.

Depending on the country, the elderly are reluctant to vaccination. On the 27th, the immunization committee of the Robert Koch Institute (RKI) in Germany issued a recommendation that the AstraZeneca vaccine should be administered only to those under the age of 65, saying there is insufficient data that it is effective for the elderly.

The Italian Medicines Agency (AIFA) approved the use of the AstraZeneca Corona 19 vaccine for adults over the age of 18 on the 30th (local time). However, AIFA recommends first use of the AstraZeneca vaccine in adults until the age of 54. For those over 55 years old, Pfizer or Modena vaccine was given first.

President Moon Jae-in visited SK Biosciences in Andong-si, Gyeongbuk on the 20th and toured the COVID-19 vaccine production facility and listened to the explanation of plant manager Lee Sang-gyun.  SK Bioscience is consigning production of AstraZeneca, a Corona 19 vaccine that is to be introduced in Korea. / Source = Hankyung DB

President Moon Jae-in visited SK Biosciences in Andong-si, Gyeongbuk on the 20th and toured the COVID-19 vaccine production facility and listened to the explanation of plant manager Lee Sang-gyun. SK Bioscience is consigning production of AstraZeneca, a Corona 19 vaccine that is to be introduced in Korea. / Source = Hankyung DB

In France, President Emmanuel Macron has questioned the efficacy of the AstraZeneca vaccine. President Macron said at a meeting with reporters in the office of the Elysee Palace on the 29th, “We believe that the AstraZeneca vaccine is hardly effective for people over the age of 65.” “The initial results.” France is reportedly scheduled to announce early next week whether its own health authorities will approve the AstraZeneca vaccine.

AstraZeneca has conducted clinical trials in the UK and Brazil mainly for adults under the age of 55. Researchers at Oxford University also revealed that data on efficacy related to elderly infections in the clinical results data published in Lancet on December 8 last year are still limited.

However, it is actively responding to questions about effectiveness raised by countries. “According to the latest data from clinical trials, the company’s vaccine has also been effective in people over the age of 65,” said AstraZeneca spokesman. Pascal Sorio AstraZeneca, CEO of AstraZeneca, said in an interview, “We have data that very strong antibodies have been formed in the elderly, similar to those found in young people.”

When the situation became like this, the government became busy. The Ministry of Food and Drug Safety held a safety and effectiveness evaluation meeting for AstraZeneca vaccine on the 31st and reviewed the availability of vaccination for the elderly aged 65 or older. The plan is to establish a’triple consultation with external experts’ procedure and undergo thorough verification. Previously, only the advice of the Central Pharmacist Review Committee (Central Pharmacopoeia), the legal advisory body of the Ministry of Food and Drug Safety, added advice from the Safety and Effectiveness Verification Advisory Group and the Final Inspection Committee for corona related drugs.

Photo = Yonhap News

Photo = Yonhap News

The part of interest is whether it is effective 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. The Ministry of Food and Drug Safety is scheduled to announce the results on the 1st (tomorrow).

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. 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’ are also expected to be AstraZeneca and Pfizer. The Ministry of Food and Drug Safety is aiming for approval in the second week of February.

Hankyung.com reporter Kim Hana [email protected]

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