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ACIP Nod For Novavax’s COVID Vaccine Comes With Criticism On Lack Of Expiration Date Packaging

 
• By Sue Sutter

Providers will have to look up the expiration date for vials of the protein-based vaccine on a website because it is not printed on the carton or packaging; omission sparks ACIP members’ frustrations with FDA and manufacturers about inadequate packaging for some other recently authorized vaccines.

novavax covid label
Novavax attributed the lack of an expiration date to logistical issues, “and we’re working toward providing labeling which is more complete.” • Source: Nielsen Hobbs; the Pink Sheet | CDC, Shutterstock images

A US Centers for Disease Control and Prevention advisory committee on 19 July unanimously recommended Novavax, Inc.’s COVID-19 vaccine for use as a primary series in adults, but panelists reiterated frustrations at what they viewed as ongoing deficiencies in packaging and labeling for COVID-19 vaccines under emergency use authorization.

In addition, members of the Advisory Committee on Immunization Practices sought more clinical guidance on the use of Novavax’s protein-based

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AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.