Vaccines

Johnson & Johnson Starts Second Global Phase III Clinical Trial of Janssen COVID-19 Vaccine

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 Show Strong Immune Responses and Better Tolerability in Older Adults for AZD1222

November 19, 2020

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

EMA Starts Rolling Review of Moderna’s COVID-19 Vaccine Candidate

November 19, 2020

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

FDA Commits to Transparency in EUA Reviews

November 18, 2020

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

Lilly’s COVID-19 mAb Treatment Receives EUA

November 10, 2020

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

FDA Grants Fast Track Designation to Novavax’s COVID-19 Vaccine Candidate

November 10, 2020

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.

Pfizer: COVID-19 Vaccine Shows High Efficacy

November 09, 2020

Interim efficacy data suggests the Pfizer/BioNTech has an efficacy rate above 90%.

EDQM Releases Document on Recombinant Viral Vectored Vaccines for COVID-19

November 03, 2020

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

GMPs Guide COVID-19 Vaccine Manufacturing

November 03, 2020

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

COVID-19 Vaccine Distribution Raises Multiple Challenges

November 02, 2020

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.