FDA Delays Full Approval Determination On Novavax’s COVID-19 Vaccine – Novavax (NASDAQ:NVAX)

In September 2024, the U.S. Meals And Drug Administration (FDA) granted Emergency Use Authorization to Novavax Inc.’s NVAX COVID-19 Vaccine, Adjuvanted (2024-2025 Formulation) (NVX-CoV2705) for lively immunization to stop COVID-19 in people aged 12 and older.

Novavax’s vaccine was included within the suggestions issued by the U.S. Facilities for Illness Management and Prevention (CDC) on June 27, 2024.

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Based on a media report on Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax’s shot.

Benzinga reached out to Novavax for feedback.

Earlier this week, Peter Marks resigned from his function on the FDA’s Heart for Biologics Analysis and Analysis.

Marks was a prime regulator on the FDA and performed a key function in pushing fast approvals of vaccines throughout the COVID-19 pandemic.

The Wall Road Journal writes that the company is now delaying the choice and has reportedly requested for extra knowledge and that the appliance is not more likely to be permitted quickly, in keeping with sources.

The FDA set an April 1 deadline for a call.

Novavax reported fourth-quarter 2024 gross sales of $88.31 million, in comparison with $291 million a 12 months, beating the consensus of $84.35 million. The lower was resulting from decrease product gross sales underneath APA agreements.

The COVID-19 vaccine maker reported an incomes lack of 51 cents per share, down from $1.44 a 12 months in the past, in line with the Wall Road Estimate.

The information comes after vaccine shares got here underneath strain final week following stories that the Trump administration plans to finish monetary help for vaccine alliance Gavi, which helps purchase vaccines for kids in growing nations. The Trump administration reportedly plans to chop billions in world well being initiatives.

Value Motion: NVAX inventory is up 1.25% at $6.09 on the final examine on Wednesday.

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