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

[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 the Janssen vaccine is approved, it will become the third vaccine available for use in the U.S. following Pfizer and Moderna vaccines, and the world's first single-dose vaccine.

Janssen conveyed this through its website on the same day and stated, "Once FDA approval is granted, we will immediately begin supplying to the U.S. government."

Janssen plans to supply 100 million doses to the U.S. by the first half of this year. Considering that the existing vaccines require two doses, the single-dose nature of this vaccine means it can cover 100 million people.

It is also easy to store, maintaining efficacy for more than three months at regular refrigeration temperatures. It can be used in regions with weak transportation infrastructure and insufficient distribution and storage facilities, such as developing countries. Paul Stoffels, Vice Chairman and Chief Scientific Officer (CSO) of Johnson & Johnson, described the emergency use application for the single-dose vaccine as "an important step toward ending COVID-19."

Janssen plans to apply for emergency use authorization from the European Medicines Agency (EMA) next week. Vice Chairman Stoffels said, "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 it," adding, "We plan to start shipping immediately once the review is completed."

Earlier, on the 29th of last month, Janssen announced that its Phase 3 clinical trials conducted in eight countries worldwide showed an average efficacy of 66%. By region, the U.S. showed the highest efficacy at 72%, while Latin America and South Africa showed 66% and 57%, respectively.

South Korea has contracted to receive 6 million doses of the Janssen vaccine starting from the second quarter of this year. Janssen's Korean branch, Korea Janssen, applied for a preliminary review to the Ministry of Food and Drug Safety on December 22 of last year. The Ministry is currently reviewing toxicity, pharmacology, and quality data of the Janssen vaccine.