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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 questions already have been asked about how the vaccine will...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine Advice

 
• 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

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

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

 
• By Sue Sutter

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.

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How Pharma Companies Can Mitigate The Impact Of US Tariffs On The Supply Chain

 
• By Ewan Townsend

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

‘The Question Is, What’s Going To Happen Next?’ – The Future For Biosimilars In Europe

 
• By Dave Wallace

With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.