Janssen Applies for Booster Shot Approval from US FDA

"100% Prevention of Severe Cases"

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] Janssen, a subsidiary of Johnson & Johnson (J&J), has applied for emergency use authorization of a COVID-19 booster shot from the U.S. Food and Drug Administration (FDA). Since it is a single-dose vaccine, the second dose serves as the booster shot.

On the 5th (local time), Janssen announced in a statement that it had applied for booster shot approval for individuals aged 18 and older. According to the Phase 3 clinical trial results submitted to the FDA by Janssen, the booster shot administered 56 days after the first dose showed a 94% effectiveness in preventing symptomatic cases and 100% effectiveness in preventing severe cases.

So far, Pfizer is the only vaccine authorized for booster shot use in the U.S. Following Pfizer, Moderna also applied for emergency use authorization for its booster shot last month. The FDA’s vaccine advisory committee is scheduled to discuss whether to recommend approval for Moderna and Janssen booster shots on the 14th and 15th.

Meanwhile, AstraZeneca applied to the FDA on the same day for emergency use authorization of AZD7442, a COVID-19 preventive treatment.

Originally developed to treat acute COVID-19 symptoms, AZD7442 showed little effectiveness as a treatment in clinical trials but demonstrated a 77% effectiveness in preventing symptomatic cases.

The main users are expected to be those who have been vaccinated but did not generate sufficient antibodies or those who could not receive the vaccine due to allergic reactions or other reasons.