'Single Dose' Janssen Applies for Emergency Use Authorization of COVID-19 Vaccine to FDA (Update)

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Janssen, a subsidiary of the U.S. pharmaceutical company Johnson & Johnson, announced on the 4th (local time) that it has applied for emergency use authorization of its vaccine to the U.S. Food and Drug Administration (FDA). If approved, it will be the first single-dose COVID-19 vaccine.

Janssen conveyed this through its website on the same day, stating, "If approved, we will immediately begin supplying to the U.S. government." It added, "We plan to supply 100 million doses to the U.S. by the first half of this year."

Unlike existing vaccines that require two doses, the Janssen vaccine only requires one dose. It is easy to store and remains effective for more than three months at regular refrigeration temperatures. Janssen described the emergency use application for the single-dose vaccine as "an important step toward ending COVID-19."

Janssen will also apply for emergency use authorization from the European Medicines Agency (EMA) next week. Janssen stated, "We will supply the vaccine as soon as possible once approvals are granted not only by the FDA but also by other countries currently reviewing the vaccine."

Previously, on the 29th of last month, Janssen announced that its global clinical trials conducted in eight countries showed an average efficacy of 66%. By region, the U.S. showed the highest efficacy at 72%, followed by 66% in Latin America and 57% in South Africa.

South Korea has contracted to receive 6 million doses of the Janssen vaccine starting from the second quarter of this year.