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Novavax’s Pending EUA Likely Less Important Than Future Updates

 
• By Derrick Gingery

Upcoming booster, adolescent data may be more commercially significant for the vaccine, which would enter a US market with few willing adults still unvaccinated. The tough prospects for one of the first COVID vaccines in development is a lesson in the importance of avoiding regulatory delays.

COVID-19 injection
Data on booster shots for Novavax's COVID-19 vaccine already has been submitted, the FDA said. • Source: Shutterstock

An emergency use authorization for Novavax, Inc.’s COVID-19 vaccine would be a major step forward, but the likely more important information, such as data on boosters and safety and efficacy in children, is yet to come.

Novavax has requested an EUA only for a two-dose primary series of its vaccine in adults 18 and older. And...

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

 
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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 Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

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

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.