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

Coronavirus Notebook: EU Moots Emergency Use Authorization Scheme For Vaccines, Janssen Product Up For 11 March Approval

 
• By Ian Schofield

Celltrion’s regdanvimab is undergoing an emergency use procedure in Europe, the European Medicines Agency and the health authorities in Canada have jointly published clinical data on the Moderna vaccine, and Canada has approved two versions of the AstraZeneca/Oxford University jab.

Smart technology of drone brings coronavirus(covid-19) vaccine to Around the world.
Efforts are being made to speed up COVID-19 vaccine availability • Source: Shutterstock

The European Commission is looking at the possibility of introducing an EU-level mechanism for issuing emergency use authorizations to speed up the availability of COVID-19 vaccines amid criticism of the slow pace of the roll-out across the bloc.

At present, all COVID-19 vaccines undergo a full centralized evaluation by the European Medicines Agency, although the process is accelerated...

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

EMA Learns Hard Lessons From US-Inspired Streamlining Pilot

 
• By Vibha Sharma

The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.

UK Drug Pricing Scheme Talks Collapse: Industry Braces For Another Year Of High Rebates

 
• By Eliza Slawther

Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.

EFPIA Rallies EU To Shield Innovative Drugs After US Tariff Cap Is Confirmed 

 
• By Neena Brizmohun

Europe’s research-based pharma industry group, EFPIA, is pressing EU policymakers to protect innovative medicines after the EU-US trade deal confirmed a 15% tariff on pharmaceutical exports. Generic products, meanwhile, have secured an exemption.

Project Orbis: Annual UK Approvals Down Since 2022, But MHRA Touts Advantages

 
• By Eliza Slawther

The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.

More from Geography

US FDA Suspends Valneva’s Ixchiq Based On Four New Serious AE Reports

 
• By Sue Sutter

After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.

Generic Industry Looking For Expanded Inspections As US FDA Rehires Staff

 
• By Grace Moser

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

US Strategic Reserve Bulking Up: New Order Focuses On API Stockpile

 
• By Laura Helbling

The White House is directing the Health and Human Services Department to replenish stockpiles of active pharmaceutical ingredients for “especially critical” medicines.