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

SK Bioscience Pulls EU Filing For COVID Jab As Regulators Shift Focus To XBB Vaccines

 
• By Eliza Slawther

The European Medicines Agency’s CHMP was set to adopt opinions on SK Bioscience’s COVID-19 vaccine and Mycovia/Gedeon’s Vivjoa for vulvovaginal candidiasis during its September meeting, but both marketing authorization filings were voluntarily withdrawn.

Withdrawn Stamp
• Source: Shutterstock

South Korea’s SK Bioscience voluntarily withdrew its EU conditional marketing authorization application (MAA) for SKYCovion/GBP510, a recombinant COVID-19 vaccine, on 1 September, ahead of this week’s meeting of the European Medicines Agency’s human medicines committee, the CHMP.

A spokesperson for SK Bioscience told the Pink Sheet that this decision was made following guidance from the World Health Organization and international regulators in May that only COVID-19 vaccines designed to target the more recent XBB strains of SARS-CoV-2 should be used

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

More from Geography

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.