European Medicines Agency recommends AstraZeneca vaccine approval… Target 18 years old or older

European Medicines Agency recommends AstraZeneca vaccine approval… Target 18 years old or older

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Third COVID-19 vaccine available in EU when officially approved

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[로이터=연합뉴스 자료사진]

(Brussels = Yonhap News) Correspondent Kim Jong-un = The European Medicines Agency (EMA) recommends conditional marketing approval for a novel coronavirus infection (Corona 19) vaccine jointly developed by multinational pharmaceutical company AstraZeneca and Oxford University in the UK on the 29th (local time). Revealed.

The EMA recommended that the vaccine should be administered to persons 18 years of age or older.

This is the third COVID-19 vaccine that EMA recommended conditional use in the EU, following a vaccine developed by US pharmaceutical company Pfizer-German Bioentech and US Modena.

The final decision is now made by the European Commission, the executive branch of the European Union, and once official approval is granted, vaccinations can be initiated within EU member states.

The EU approved the previous two vaccines a few hours after the EMA recommendation.

EMA said that when combined with the results of clinical trials conducted in the UK, Brazil and South Africa, the AstraZeneca vaccine has been shown to be safe and effective in preventing COVID-19 in people over the age of 18.

The EMA added that most of the participants in the vaccine trial were between 18 and 55 years of age, and there are still not enough results to provide a measure of how well the vaccine will work in the ages over 55.

EMA, however, expects to have a protective effect based on experience with other vaccines, taking into account the immune response seen at that age group.

Earlier, some observations have been made that the EMA may recommend vaccination only to those under the age of 65.

The vaccination committee under the Robert Koch Institute (RKI), a German disease control agency, said that the previous day, the AstraZeneca-Oxford vaccine was not sufficiently clinically tested on 65 years of age or older. Said.

In addition, EMA added that the vaccine should be administered in the first and second doses, and the vaccination interval should be 4 to 12 weeks.

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The EU’s conditional marketing approval is a procedure to quickly respond to emergencies that threaten public health such as COVID-19, allowing pharmaceuticals to be sold for one year in 27 member states and can be renewed annually.

The EU previously approved the conditional sale of the Modena vaccine in the EU earlier this month following the COVID-19 vaccine jointly developed by US pharmaceutical company Pfizer and Bioentech on the 21st of last month according to EMA’s recommendation.

Accordingly, in EU member states, Pfizer-Bioentech vaccination began on the 27th of last month.

The AstraZeneca vaccine was approved for emergency use in India, Argentina, and Mexico starting in the UK on the 30th of last month.

The average preventive effect of this vaccine is 70.4%, which is inferior to that of Pfizer (95%) and Modena (94.5%).

The EU has signed a contract to purchase 400 million vaccine doses with AstraZeneca on behalf of the member states.

However, even if the vaccine is officially approved, the EU must resolve the issues surrounding the initial supply with the pharmaceutical company.

When AstraZeneca announced on the 22nd that the initial supply to Europe would decrease due to a disruption in the production of the Corona 19 vaccine, the EU demanded that the UK-produced vaccine be returned to the EU, causing friction between the two sides.

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2021/01/30 00:54 sent

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