Vaxcyte Says FDA Grants Fast-Track Designation to Invasive Pneumococcal Disease Vaccine

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By Michael Dabaie

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Vaxcyte Inc. said the US Food and Drug Administration granted fast-track designation to VAX-24, the company’s vaccine candidate to prevent invasive pneumococcal disease in adults.

The designation is an FDA process to facilitate the development and expedite the review of drugs that treat or prevent serious conditions and fill an unmet medical need.

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The clinical-stage vaccine company said it completed a pre-investigational new drug meeting with the FDA regarding the VAX-24 pediatric program. Vaxcyte said it got positive written feedback from the FDA supporting the initiation of a pediatric study that proceeds directly into infants.

Pneumococcal disease an infection caused by Streptococcus pneumoniae bacteria. It can result in IPD, including meningitis and bacteremia, and noninvasive PD, including pneumonia, otitis media and sinusitis. Despite universal vaccination for PD in infants and in many adults in the US, the overall incidence of PD is substantial and is driven by emerging serotypes not covered by currently available vaccines, the company said.

Vaxcyte in July said it completed enrollment in the Phase 2 portion of the continuing Phase 1/2 proof-of-concept study evaluating VAX-24 in healthy adults age 50 to 64. The company also said it dosed the first participants in a separate Phase 2 study of VAX-24 in healthy adults 65 years and older.

Write to Michael Dabaie at [email protected]

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Credit: www.marketwatch.com /

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