Coronavirus Update: Pfizer Vaccine Candidates Gain Fast-Track Status

Two mRNA Candidates Selected

The granting of fast-track status is a clear signal that the US FDA wants to maintain its high standards of drug and vaccine appraisal.

Face covering
Face coverings will be mandatory in England's shops from 24 July, bringing it into line with Scotland and other European nations such as Spain, Italy and Germany.

Two of the four investigational COVID-19 vaccine candidates being developed by Pfizer Inc. and BioNTech have gained fast track designation from the US Food and Drug Administration.

The two candidates using the mRNA-based vaccine platform are BNT162b1 and BNT162b2 and are the most advanced in the partners’ ongoing Phase I/II clinical studies in the US and Germany....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 COVID-19

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By 

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Arcturus and CSL Take on Pfizer With Longer-Lasting COVID Vaccine

 
• By 

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Under-Pressure Moderna Banks $590m To Speed Up Bird Flu Vaccine

 
• By 

A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.

Stock Watch: Q3, Bonfire Of The Vaccine Manufacturers

 
• By 

Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.

More from Scrip

Bayer Has BI In Its Sights With Priority Review For HER2 Lung Cancer Drug

 
• By 

Sevabertinib gets onto the FDA's approval fast track three months after zongertinib.

InflaRx Stock Sinks As Vilobelimab Fails Phase III Skin Trial

 
• By 

A study of the German biotech's intravenous complement factor C5a antibody for pyoderma gangrenosum was stopped for futility.

In partnership with

Podcast Series: Navigating Regulatory Changes & Market Dynamics: CRO Perspectives on the Future of Clinical Trials

Insights from Novotech on Evolving Trends Impacting Global Clinical Development