EMA initiates rolling review of Moderna’s COVID-19 vaccine
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.
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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).
Researchers say the promising results warrant larger trials evaluating fluvoxamine as a potential intervention to prevent COVID-19 patients developing severe symptoms.
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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.
This article explores how COVID-19 has impacted clinical investigation sites and what companies could do to mitigate the effect on trials moving forwards.
Russia’s Sputnik V, a potential COVID-19 vaccine, was 92 percent effective at protecting people from the coronavirus, interim results have shown.
AstraZenaca reveals Calquence (acalabrutinib) did not increase the proportion of hospitalised COVID-19 patients who remained alive and free of respiratory failure.
The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
Subject to regulatory approval, EU member states will be supplied with the potentially highly effective BNT162b2 COVID-19 vaccine candidate.
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
The trial was stopped because the data suggested that injections of the long-acting antiretroviral drug cabotegravir (CAB LA) are highly effective for HIV pre-exposure prophylaxis (PrEP) in women.
The COVID-19 vaccine candidate BNT162b2, made by Pfizer and BioNTech, has demonstrated over 90 percent efficacy in its first interim analysis during its Phase III trial.
The interim Phase I data suggests CVnCoV can safely induce a neutralising antibody response similar to that of convalescent COVID-19 patients with two 12μg vaccine doses.
Developers suggest that the potency, stability and manufacturability of the nanoparticle vaccine candidate could enable vaccination against COVID-19 on a global scale.