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Moderna’s COVID-19 Second Booster Authorization Largely Thanks To Pfizer/BioNTech Data

 
• By Sue Sutter

Safety and effectiveness of an mRNA-1273 second booster dose was inferred in large part by extrapolation from reported evidence following use of the Pfizer/BioNTech COVID-19 vaccine in individuals 60 years and older in Israel, FDA review memos show.  

Piggy back
Moderna piggybacked on Pfizer/BioNTech's data for a second booster shot. • Source: Alamy

The US Food and Drug Administration’s recent authorization of a second booster dose of Moderna, Inc.’s COVID-19 vaccine largely piggybacked on Israeli data specific to Pfizer Inc./BioNTech SE’s competing mRNA product.

“Safety and effectiveness of the Moderna COVID-19 vaccine second booster dose is inferred in large part by extrapolation from reported evidence following use of the Pfizer/BioNTech COVID-19 vaccine in...

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• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.

US FDA Meeting Drought Ends … With A Vengeance

 
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EU Pharma Reform Package Clears Big Political Hurdle After Council Adopts Position

 
• By Neena Brizmohun

The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
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Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.