OR WAIT null SECS
November 24, 2020
HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.
November 23, 2020
An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.
Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.
November 19, 2020
A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.
Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.
Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.
November 18, 2020
Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.
November 10, 2020
FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.
The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.
November 09, 2020
Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.