'Single-dose' Janssen applies for European approval... Results expected mid-next month

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[Asia Economy Reporter Cho Hyun-ui] Janssen, a subsidiary of the US pharmaceutical company Johnson & Johnson, has applied for conditional marketing authorization for its COVID-19 vaccine to the European Medicines Agency (EMA). If approved, it will become the fourth vaccine available for use in Europe.

On the 16th (local time), EMA announced this on its website and stated, "We have expedited the evaluation of the vaccine ahead of the usual schedule and plan to announce the results around mid-next month."

EMA has already reviewed some data on the Janssen vaccine. With this application, it will evaluate efficacy, safety, and quality.

The EU has already secured 400 million doses of the Janssen vaccine. Considering that it requires only one dose, unlike existing vaccines that require two doses, this amount is sufficient to vaccinate 400 million people.

Vaccines approved by EMA and recommended for emergency use are supplied to the European market after approval by the European Commission. So far, three vaccines have received EMA supply approval: Pfizer, Moderna, and AstraZeneca.

Earlier, on the 4th, Janssen applied for emergency use authorization from the US Food and Drug Administration (FDA). The average preventive efficacy of the Janssen vaccine is 66%. According to phase 3 clinical trials conducted by Janssen in eight countries worldwide, the efficacy was highest in the US at 72%, and 66% and 57% in Latin America and South Africa, respectively.

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