1. Pink Sheet
  2. >>Geography
  3. >>Europe

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Europe

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

BioMarin Fights Back After NICE Blocks English Funding For £500K Batten Disease Drug

 
• By Neena Brizmohun

The health technology assessment institute, NICE, said the price BioMarin was asking for Brineura was too high, even though its appraisal committee applied a cost-effectiveness threshold ten times higher than usual.

Dutch HTA Calls For “Socially Acceptable” Price For Gene Editing Therapy Casgevy

 
• By Francesca Bruce

Vertex and Biogen are working with the Dutch government to ensure access for eligible patients.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

More from Geography

Japan To Cut Leqembi Price By 15% Following Cost Effectiveness Review

 
• By Lisa Takagi

While Japanese government announces 8-15% price cuts for four drugs, including Leqembi, industry groups urge operational improvements to national cost effectiveness assessment scheme.

Precigen’s Papzimeous Approval Allows US FDA CBER Director To Emphasize Flexibility

 
• By Bridget Silverman

Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.