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US FDA's Spikevax Review By The Numbers

 
• By Sue Sutter

A timeline of the development and approval of Moderna's mRNA vaccine, and a listing of FDA reviewers on the biologics license application.

Drug Review Profile: Spikevax Chronology
Moderna's COVID-19 vaccine moved from pre-IND meeting to full approval in less than two years. • Source: Alamy

Elsewhere in this Drug Review Profile, the Pink Sheet examines how the US Food and Drug Administration took the Omicron variant's predominance into account in its review and January approval of Moderna, Inc.'s COVID-19 vaccine Spikevax.(Also see "COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US" - Pink Sheet, 4 May, 2022.)

Below is the clinical development review timeline and a table of the agency reviewers involved.

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
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By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

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• By Vibha Sharma

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