GSK’s Walmsley On US v. EU COVID-Flu Combos, RSV Branding, And Investing In Infectious Disease

COVID vaccine makers already licensed in the US will have a leg up on in the combination respiratory vaccine space since aspiring new entrants like GSK will have to do efficacy work to get FDA approval. CEO Walmsley offers insight into the company’s vaccine strategy.

Vaccine vials with GSK logo in background
GSK executives touted the company’s vaccine plans at the site of its new acquisition Affinivax along BIO 2023. • Source: Shutterstock/Golden Shrimp

The US Food and Drug Administration’s data expectations for combination COVID and flu vaccines are higher than those of its European counterparts, creating potential difficulties for sponsors, GSK plc’s Philip Dormitzer, the company’s senior VP and global head of vaccines research and development, said.

Key Takeaways
  • EU standards for combo flu-COVID vaccines may be easier for new entrants than FDA’s.
  • GSK considering challenge studies, post-licensure studies in EU to help obtain data for US approval of combo product

The US will likely require new COVID vaccine entrants to conduct efficacy studies for their combo product, while immunological studies should be acceptable in the EU

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

More from Vaccines

More from Pink Sheet

Few Takers For EMA’s OPEN Pathway Prompts Rethink

 
• By 

While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.