1. Pink Sheet
  2. >>Geography
  3. >>Europe
  4. >>United Kingdom

Coronavirus Notebook: UK On Cusp Of First Vaccine Approval, Moderna To File mRNA-1273 in US & EU

 
• By Ian Schofield

Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.

Corona virus vaccine
The UK is preparing for COVID-19 vaccine roll-out • Source: Shutterstock

The UK has bought another two million doses of the Moderna, Inc. coronavirus vaccine, bringing the total on order to seven million. It will now have enough of Moderna's mRNA-1273 to immunize about 3.5 million people, and if it is approved, the seven million doses could start to be delivered to the UK as early as spring 2021, “the same timetable as other countries in Europe,” the government said. The UK now has access to a total of 357 million doses from seven different developers.

Moderna announced on 30 November that it was about to request an emergency use authorization from the US Food and...

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 United Kingdom

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

 
• By Urtė Fultinavičiūtė

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

 
• By Eliza Slawther

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.

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.

UK Medicines Shortages Inquiry Eyes Full Reshoring of Drug Manufacturing

 
• By Neena Brizmohun

A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.

More from Europe

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

England: Pharma Firms To Benefit From Parallel HTA And Regulatory Pathway

 
• By Eliza Slawther

The UK drug regulator and England’s health technology assessment agency have joined forces under an information sharing agreement, aimed at accelerating patient access to newly approved medicines by three to six months.