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Moderna's COVID-19 Vaccine Booster US FDA Panel Nod Driven By Pragmatism

 
• By Sue Sutter

Despite lack of enthusiasm with immunobridging study data, the panel endorsed emergency use in certain at-risk populations, in part because it would be hard to turn down the Moderna booster when an identical EUA had been issued for Pfizer/BioNTech's mRNA vaccine.

Against a wall
FDA panel members may have felt like they'd been backed into a wall with the Moderna booster EUA recommendation so closely following the Pfizer/BioNTech authorization. • Source: Alamy

A US Food and Drug Administration advisory committee on 14 October unanimously recommended emergency use authorization of a booster dose of Moderna, Inc.’s COVID-19 vaccine for select populations – an endorsement made not so much out of enthusiasm about the data but rather “gut feeling” and pragmatism.

The Vaccines and Related Biological Products Advisory Committee voted 19-0 that the safety and effectiveness data support use of a 50 mcg booster dose of mRNA-1273 under EUA in three at-risk populations based upon age,

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• By Eliza Slawther

European pharma trade associations EFPIA and EUCOPE outline their respective views on how the EU’s pharma legislation overhaul should tackle antimicrobial resistance, and why transferable exclusivity vouchers alone will not suffice as incentives.

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.