Vaxcyte (PCVX) Jefferies Global Healthcare Conference 2025 summary

Recent clinical and regulatory updates

• Positive first clinical data in infants for the 24-valent vaccine disclosed in March, confirmed by external experts as promising for future success.

• Regulatory environment remains supportive, with consistent FDA engagement and no changes to the established approval pathway for pneumococcal conjugate vaccines (PCVs).

• Ongoing interactions with FDA leadership have been stable, with regulatory teams and review processes unchanged through recent transitions.

Adult and pediatric market outlook

• Adult PCV market currently represents 15-20% of an $8 billion global category, with recent U.S. policy changes expanding eligibility to adults 50+, increasing the addressable population by 65 million.

• International markets are following the U.S. lead, with countries like Germany and Australia moving toward universal adult vaccination, expected to drive significant market growth.

Clinical development and data insights

• Phase III adult VAX-31 study is on track to start by mid-year, with data expected next year; breakthrough therapy designation enables frequent FDA interaction.

• VAX-24 infant data showed strong immunogenicity and safety, with higher doses improving responses; some serotypes showed lower responses, but these were not clinically significant.

• Upcoming VAX-31 infant study will test higher doses, aiming for broader coverage and improved immune responses, with results anticipated next year.