Pfizer and BioNTech submit for EUA of COVID-19 vaccine with FDA
The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
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The companies suggest if the Emergency Use Authorization (EUA) is approved, high-risk patients in the US could begin receiving the BNT162b2 vaccine by the end of December 2020.
The European Directorate for the Quality of Medicines & Healthcare has announced three new guidelines outlining how to test the quality of COVID-19 vaccines.
The University of Oxford and AstraZeneca COVID-19 vaccine candidate is effective in healthy adults aged 56-69 and those over 70 years of age, a Phase II study has demonstrated.
The concluded Phase III study of BNT162b2 met all primary efficacy endpoints, with a consistent 95 percent efficacy across all patient populations.
Reports have found that the COVID-19 pandemic is providing new opportunities for contract and development manufacturing organisations (CDMOs).
J&J has initiated a global Phase III clinical trial to study JNJ-78436735, a vaccine candidate for the prevention of COVID-19.
The EMA's safety monitoring plan outlines how new information after authorisation of COVID-19 vaccines will be collected and reviewed.
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
The nOPV2 vaccine has received emergency use listing and will be used to combat outbreaks of circulating vaccine-derived polio viruses (cVDPVs).
The analysis reveals that mRNA-1273 was generally well tolerated and prevented COVID-19 with an efficacy of 94.5 percent in a Phase III study.
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
Russia’s Sputnik V, a potential COVID-19 vaccine, was 92 percent effective at protecting people from the coronavirus, interim results have shown.
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
The FDA has given Fast Track Designation to NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, created using recombinant nanoparticle technology.
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.