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AstraZeneca’s COVID Vaccine US Filing Is Delayed – Really Delayed. Here Are Two Theories Why

 
• By Derrick Gingery

Based on the historical time between Phase III results and filing announcements, AstraZeneca is way behind the pace. The firm will soon have waited longer to submit its EUA to the US FDA than the three already-authorized products waited combined.

Aerial overhead view of trailer trucks delivering a vaccine. 3D rendering
AstraZeneca has now waited longer to file an EUA request for its COVID-19 shot than the FDA took to authorize any of the three vaccines already being used in the US. • Source: Shutterstock

AstraZeneca PLC still intends to apply for a US Food and Drug Administration emergency use authorization of its coronavirus vaccine, but preparations are taking longer than predecessors, potentially influenced by the appearance of rare blood clots among recipients.

Thirty-one days have passed since the company announced positive interim Phase III data for its proposed vaccine, AZD1222, on 22...

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• By Sue Sutter

Pediatric Advisory Committee will weigh the FDA's recommendation that routine safety monitoring continue for Merck & Co's Gardasil and Sanofi's Fluzone and Dengvaxia despite a political climate that has been unkind to vaccines.

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COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By Sue Sutter

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

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EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

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Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.