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Novavax Vaccine Approval Delayed Amid New Trial Requirements

4/29/2025

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Summary

Story summary

Novavax's COVID vaccine, granted emergency use in August 2022, is delayed in full FDA approval due to new trial requirements.
FDA Commissioner Marty Makary suggested that updated vaccines may also need new trials, raising approval concerns.
This vaccine is the sole protein-based option for individuals aged 12 and older.
Political interference and regulatory changes have complicated the approval process.
Experts fear these hurdles may slow vaccine updates amid ongoing COVID-19 mutations.

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Story summary

Novavax's COVID vaccine, granted emergency use in August 2022, is delayed in full FDA approval due to new trial requirements.
FDA Commissioner Marty Makary suggested that updated vaccines may also need new trials, raising approval concerns.
This vaccine is the sole protein-based option for individuals aged 12 and older.
Political interference and regulatory changes have complicated the approval process.
Experts fear these hurdles may slow vaccine updates amid ongoing COVID-19 mutations.