Novavax Files COVID-19 Vaccine Candidate With UK Regulator

Product Still Under Rolling Review In EU

The company says it expects a “positive decision” on the first approval application for a protein-based coronavirus vaccine in the UK. If approved, NVX-CoV2373 would become the fifth COVID-19 jab to reach the market there.

Close-up view of searching information on COVID 19 vaccine on the internet
A fifth COVID-19 vaccine could soon be approved by the MHRA • Source: Alamy

Novavax, Inc. has completed its rolling regulatory submission to the UK regulator, the MHRA, for the approval of its COVID-19 vaccine NVX-CoV2373. If approved, it will join the four other coronavirus vaccines already on the market.

The filing is noteworthy for two reasons, one being that it is the first for a protein-based coronavirus vaccine in...

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 Europe

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

More from Geography

Global Pharma Guidance Tracker - July 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Research Advances And Filings Prompt EMA To Revise Alzheimer’s Trial Guideline

 

Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By 

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.