European Medicines Agency Reviews Pfizer Vaccine Booster Shot Approval Application

"Review of Clinical Trial Results for Pfizer Booster Shot Submission"
Whether a booster shot is needed and the target recipients to be reviewed over several weeks

[Image source=AP Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The European Medicines Agency (EMA) announced that it has begun reviewing Pfizer's application for an additional COVID-19 vaccine booster shot. A comprehensive evaluation of the booster shot's efficacy, necessity, and target recipients is expected to take place over several weeks. Already, Germany and France within Europe are known to be planning booster shot campaigns targeting the elderly, and if the EMA approves the booster shot, it is anticipated that countries within the European Union (EU) will actively join the booster shot efforts.

On the 6th (local time), the EMA stated in a press release, "The EMA is reviewing whether individuals aged 16 and older who have completed their second dose should receive a booster shot after six months," adding, "This review is an evaluation of Pfizer's application for booster shot approval to determine whether the booster is truly necessary and how effective it is."

The EMA further explained, "We are reviewing clinical trial data from Pfizer involving 300 healthy adults who received a third dose of the COVID-19 vaccine, and a conclusion is expected within the next few weeks. The EMA is assessing Pfizer's application and clinical data to verify if there is sufficient evidence to support additional doses. Separately, data regarding the necessary vaccine dosage for additional shots in severely immunocompromised patients is also being evaluated."

Earlier, France and Germany announced that they would prioritize administering a third COVID-19 vaccine dose to the elderly starting this month. If the EMA formally approves the booster shot, Europe is expected to follow Israel and the United States in launching full-scale booster shot campaigns.

The booster shot was first initiated worldwide in Israel on July 30, and various countries are currently considering its implementation. The U.S. Food and Drug Administration (FDA) is also reviewing related data submitted by Pfizer. The U.S. government is reportedly planning to begin additional COVID-19 vaccinations starting on the 20th of this month.

This content was produced with the assistance of AI translation services.