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Coronavirus Notebook: UK Supplying Bivalent Spikevax Via Special Mechanism, Next-Generation BA.4/BA.5 Vaccines Filed In EU

 
• By Ian Schofield

The European Medicines Agency could make an EU approval recommendation on two bivalent Omicron BA.1-targeting vaccines on 1 September. 

Mutated coronavirus SARS-CoV-2 flu disease pandemic
How will the new vaccines fare against virus variants? • Source: Shutterstock

The first batches of Moderna, Inc.’s bivalent booster version of its Spikevax COVID-19 vaccine, which received its first approval worldwide in the UK earlier this month, will enter the supply chain by the end of August.

The bivalent vaccine consists of 25mcg of elasomeran (the original Spikevax), an mRNA molecule that encodes the viral spike protein of the SARS-CoV-2 virus, and 25mcg of

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More from Europe

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.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
• By Neena Brizmohun

Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

More from Geography

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

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.