J&J submits Janssen COVID-19 vaccine to WHO for emergency use listing

By The Science Advisory Board staff writers

February 22, 2021 -- Johnson & Johnson announced it has submitted Janssen's investigational single-dose COVID-19 vaccine candidate to the World Health Organization (WHO) for emergency use listing.

The submission, which includes interim efficacy and safety results from the phase III Ensemble clinical trial, marks the completion of the firm's rolling submission of its vaccine candidate to the WHO.

The emergency listing is a prerequisite to supply vaccines to the new Covax facility to procure and distribute COVID-19 vaccines in 190 participating countries, including 92 lower-income countries.

The firm has rolling submissions for the investigational single-dose COVID-19 vaccine initiated in several countries.

The next generation of COVID-19 vaccines: Gallo on next steps
What will the next generation of COVID-19 vaccines look like? In the first of a two-part series, The Science Advisory Board spoke with pioneering...
Janssen's COVID-19 vaccine submitted to EMA for emergency use
Johnson & Johnson announced that Janssen has submitted a conditional marketing authorization application to the European Medicines Agency (EMA) for...
Janssen files EUA for COVID-19 vaccine, FDA sets advisory meeting date
Johnson & Johnson announced that Janssen Biotech has submitted an application to the U.S. Food and Drug Administration (FDA) requesting emergency...
J&J single-shot COVID-19 vaccine meets end points
Johnson & Johnson released efficacy and safety data from its phase III Ensemble clinical trial, which demonstrates that the investigational single-dose...
Top biopharma companies form data exchange nonprofit
Ten of the world's largest biopharmaceutical companies publicly launched a new nonprofit corporation, Accumulus Synergy. The aim is to support interactions...

Copyright © 2021 scienceboard.net


Register below for our weekly Letter from the Editor to receive the latest Science news and insights.
Email
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter