EMA "AZ Vaccine Safe"... Germany, France, Italy Resume Vaccinations
[Asia Economy Reporter Park Byung-hee] The European Medicines Agency (EMA) concluded on the 18th (local time) after reviewing cases of thrombosis following AstraZeneca vaccine administration that the vaccine is not associated with an overall increased risk of blood clots. Accordingly, the EMA decided to maintain its recommendation for approval, stating that the AstraZeneca vaccine is a "safe and effective vaccine." Major European countries including Germany, France, Italy, and Spain immediately decided to resume AstraZeneca vaccinations.
According to foreign media such as AP, the EMA held an extraordinary meeting of the Safety Committee on the same day, and after drawing conclusions from the information collected so far, stated that the benefits of the vaccine outweigh the risks of side effects in relation to reports of blood clots in some vaccinated individuals.
EMA Chief Executive Emer Cook said at a press conference, "AstraZeneca is a safe and effective vaccine."
However, Chair Cook stated that the "link to a very rare specific type of blood clot cannot be definitively excluded" and recommended adding explanations about these cases to vaccine information so that patients and healthcare workers can be informed. In this regard, the EMA noted that the vaccine may be associated with very rare cases of thrombosis related to thrombocytopenia, mentioning cerebral venous thrombosis and disseminated intravascular coagulation. The EMA added that although causality with the vaccine has not been proven, there is a very small possibility and further analysis is needed.
Cook explained that among about 20 million people vaccinated with this vaccine in the UK and the European Economic Area (EEA), there were 25 such rare cases, of which 9 people died. Most of these cases were women under 55 years old. The EMA stated that before and after the vaccine's approval, 469 cases of thrombosis were reported among people vaccinated with this vaccine in these regions, which is lower than the number expected in the general population.
The World Health Organization (WHO) also recommended continuing AstraZeneca vaccinations on the 17th, stating that the benefits of the COVID-19 vaccine outweigh the risks.
Following the EMA's announcement, major European countries such as Germany, France, Italy, and Spain, which had suspended AstraZeneca vaccinations as a precaution, announced that they would immediately resume vaccinations.
German Health Minister Jens Spahn held a press conference and said, "After consultations with the federal government, 16 states, and the vaccine approval authority Paul Ehrlich Institute (PEI), it was decided to resume vaccinations starting tomorrow."
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French Prime Minister Jean Castex also announced at a press conference that AstraZeneca-Oxford vaccinations would immediately resume from the afternoon of the 19th. Italy also decided to resume AZ vaccine vaccinations from the 19th. Spain announced that AstraZeneca vaccinations would resume on the 24th of this month, according to Health Minister Carolina Darias.
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