1. Pink Sheet
  2. >>Vaccines

AstraZeneca's COVID-19 Vaccine On Hold: A Reminder Product Development Is Never Straightforward

Phase III Trial Stopped A Week After Initiation

 
• By Jessica Merrill

AstraZeneca – one of the frontrunners in the race to develop a COVID-19 vaccine – has voluntarily put a hold on the Phase III trial due to an adverse event.

Stop barrier
AZ/OXFORD COVID-19 VACCINE IS ON HOLD • Source: Shutterstock

AstraZeneca and the University of Oxford have put a voluntary clinical trial hold on the Phase III trial testing their COVID-19 vaccine due to an adverse event. The companies confirmed the move in the evening on 8 September, only about a week after initiating the Phase III trial.

While the development of several COVID-19 vaccines across the industry has been moving at an unprecedented pace and remarkably smoothly...

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 Vaccines

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 
• By Alaric DeArment

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

Double Duty At US FDA: Tidmarsh Will Temporarily Lead Both CDER And CBER

 
• By Sarah Karlin-Smith

Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.

More from Pink Sheet

Lilly’s Price Deal For Mounjaro In UK A Harbinger Of The MFN Future?

 
• By Cathy Kelly

The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.

GDPR Clarity For Pharma: Industry Code Nears EU-Wide Approval After Six-Year Journey

 
• By Vibha Sharma

The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.

UK Initiative Steps Up Efforts To Tackle Recruitment Bottlenecks In Dementia Trials

 
• By Anabel Costa-Ferreira

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.