European Medicines Agency "AstraZeneca Applies for COVID Vaccine Approval" (Comprehensive)
Conclusion Expected by the End of This Month... Third Vaccine Usable Within the EU Upon Approval
The United Kingdom will be the first in the world to begin administering the novel coronavirus (COVID-19) vaccine jointly developed by Oxford University and AstraZeneca, according to reports by The Guardian and others on the 3rd (local time). On the 30th of last month, the UK government granted emergency approval for the AstraZeneca COVID-19 vaccine and distributed 530,000 doses nationwide. Vaccinations will simultaneously start on the 4th at major hospitals and local GP clinics. The photo shows the AstraZeneca COVID-19 vaccine at a hospital in Haywards Heath, southern England, taken on the 2nd.
The European Medicines Agency (EMA) announced on the 12th (local time) that the multinational pharmaceutical company AstraZeneca has submitted an application for conditional marketing authorization for its COVID-19 vaccine.
The EMA plans to conduct an expedited evaluation process and added that discussions on the vaccine approval will take place by the 29th, when the EMA expert committee meeting is scheduled.
The EU's conditional marketing authorization is a procedure designed to respond quickly to public health emergencies such as COVID-19, allowing the medicine to be sold in the 27 member states for one year, with the possibility of annual renewal.
If the EMA recommends conditional marketing authorization, the European Union (EU) will make the final decision, and once official approval is granted, vaccinations can begin within EU member states.
In this case, the AstraZeneca vaccine, co-developed with the University of Oxford, will become the third vaccine available for use within the EU, following the COVID-19 vaccines developed by the US pharmaceutical company Pfizer-Germany's BioNTech and the US company Moderna.
Earlier, following the EMA's recommendation, the EU approved the conditional marketing authorization of the Moderna vaccine earlier this month, after the Pfizer-BioNTech COVID-19 vaccine was approved on the 21st of last month.
Accordingly, vaccinations with the Pfizer-BioNTech vaccine began in EU member states on the 27th of last month.
The AstraZeneca vaccine received emergency use authorization starting on the 30th of last month in the UK, India, Argentina, Mexico, and other countries.
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The EU has signed a purchase agreement for 400 million doses of the AstraZeneca vaccine on behalf of its member states.
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