An application for Emergency Use Authorization (EUA) has been submitted by Janssen Biotech for its investigational single-dose vaccine against coronavirus disease 2019 (COVID-19). The Food and Drug Administration (FDA) has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for February 26, 2021 to discuss the emergency use request.
The EUA submission is based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial, which included 44,325 adults in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States (US). Participants were randomly assigned to receive JNJ-78436725, a recombinant vector vaccine, or placebo intramuscularly as a single dose.
An interim analysis (based on 43,783 participants and 468 symptomatic cases) showed that the vaccine candidate was 66% effective in preventing moderate to severe COVID-19 at 28 days post-vaccination among all participants, including those infected with an emerging viral variant; onset of protection was observed as early as day 14. The vaccine candidate was also found to be 85% effective in preventing severe/critical disease and demonstrated complete protection against COVID-19 related hospitalization and death at 28 days post vaccination.
“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” said Acting FDA Commissioner Janet Woodcock, MD.
According to Paul Stoffels, MD, Johnson & Johnson’s Vice Chairman of the Executive Committee and Chief Scientific Officer, shipment of the vaccine will begin immediately once authorization is granted. The Company expects to supply 100 million doses to the US in the first half of 2021. The product is estimated to remain stable for 2 years at -20°C (-4°F) and at least for 3 months at 2-8°C (36°F–46°F).
- Johnson & Johnson announces submission of application to the US FDA for Emergency Use Authorization of its investigational single-shot Janssen COVID-19 vaccine candidate. [press release]. New Brunswick, NJ: Johnson & Johnson; February 4, 2021.
- FDA Announces advisory committee meeting to discuss Janssen Biotech Inc.’s COVID-19 vaccine candidate. [press release]. Silver Spring, MD: US Food and Drug Administration; February 4, 2021. February 4, 2021.