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Coronavirus Notebook: Moderna Claims 94.5% Vaccine Efficacy, Janssen Starts Second ENSEMBLE Trial

 
• By Ian Schofield

The European Medicines Agency has begun a rolling review of Moderna’s mRNA vaccine, and its new executive director, Emer Cooke, has taken up her role with a promise to make tackling COVID-19 her “number one priority.” 

EU Coronavirus vaccine, Europe. Covid-19 vaccination, flu prevention, immunization concept. Vial dose and medical syringe, European Union flag background. 3d illustration
Moderna's COVID-19 vaccine is now under rolling review in the EU • Source: Shutterstock

The big news of the week – and it’s only Monday – is that the US firm Moderna, Inc. is claiming an efficacy rate of 94.5% for its mRNA COVID-19 vaccine following an interim analysis of the Phase III COVE trial data.

The results put Moderna slightly ahead of both the Pfizer Inc./BioNTech SE and Russian Sputnik V vaccines, which have recently claimed efficacy rates of 90% and 92% respectively....

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More from Europe

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

More from Geography

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.