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Third COVID-19 vaccine available in the EU when officially approved
The European Medicines Agency (EMA) announced on the 29th (local time) that it recommends conditional marketing approval for a new vaccine against coronavirus infection (Corona 19) jointly developed by the multinational pharmaceutical company AstraZeneca and the University of Oxford in the United Kingdom.
The EMA recommended that the vaccine be given to people 18 years of age and older.
This is the third Corona 19 vaccine recommended by the EMA for conditional use in the EU, after a vaccine developed by the American pharmaceutical company Pfizer-German Bioentech and the American 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 begin within EU member states.
The EU approved the two previous vaccines a few hours after the EMA’s recommendation.
The 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 the majority of participants in the vaccine trial were between the ages of 18 and 55, and there are not yet enough results to provide a measure of how well the vaccine will work at ages over 55.
However, EMA expects to have a protective effect based on experience with other vaccines, taking into account the immune response observed in that age group. EMA scientific experts said the vaccine could also be used in older people.
Previously, some observations have been made that the EMA may recommend vaccination only for those under 65 years of age.
The vaccination committee of the Robert Koch Institute (RKI), a German disease control agency, said the day before, the AstraZeneca-Oxford vaccine had not been sufficiently clinically tested in people 65 and older.
In addition, the EMA added that the vaccine should be administered in the first and second doses, and the vaccination interval should be 4 to 12 weeks.
The EU conditional marketing approval is a procedure to respond quickly to emergencies that threaten public health such as COVID-19, allowing pharmaceutical products 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 after the Corona 19 vaccine jointly developed by the US pharmaceutical company Pfizer and Bioentech on the 21st of last month in accordance with the EMA’s recommendation.
Consequently, in the EU member states, the Pfizer-Bioentech vaccination started 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%, lower than that of Pfizer (95%) and Modena (94.5%).
The EU has signed a contract to purchase 400 million doses of vaccines with AstraZeneca on behalf of the member states.
However, even if the vaccine is officially approved, the EU must resolve the problems related to the initial supply with the pharmaceutical company.
When AstraZeneca announced on the 22nd that the initial supply to Europe would be reduced due to a disruption in COVID-19 vaccine production, the EU demanded that the UK-produced vaccine be returned to the EU, causing friction between both parts. .
/ yunhap news
