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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 20, 2020
November 18, 2020
Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.
November 17, 2020
Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.
November 16, 2020
The new facility, which is expected to be operational by mid-2026, will utilize cell-based technology to produce influenza vaccines for influenza pandemics and seasonal vaccination programs, both in Australia and globally.
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 03, 2020
In the wake of its efforts to develop a COVID-19 vaccine candidate, the company has secured two additional properties in the Gaithersburg, MD area.
Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.