Pfizer and BioNTech: Slightly Lowering Our MRNA Vaccine Forecast Due to US Policy Headwinds

The US Food and Drug Administration’s Vinay Prasad issued a memo on Aug. 25 detailing the agency’s evolving thoughts on the coadministration of vaccines and approval requirements. A meeting of the Advisory Committee on Immunization Practices is scheduled for Sept. 18-19.

Why it matters: Pfizer’s PFE and BioNTech’s BTNX covid vaccine Comirnaty still makes up roughly 8% of Pfizer’s top line and the majority of BioNTech’s profits, and while international sales are protected by multiyear contracts through at least 2026, vaccine hesitancy and US policy changes could affect US demand.

• The memo, along with the recent departure of CDC Director Susan Monarez and the defunding of mRNA research, are some of the latest indicators that Secretary of Health and Human Services Robert F. Kennedy Jr. is continuing to erect barriers to the administration and development of vaccines in the US.
• If the ACIP does not provide a recommendation for covid vaccinations at the September meeting, pharmacists in some states may not be allowed to administer the vaccines this season, and insurers won’t be required to cover them.

The bottom line: After reducing our sales forecasts for Comirnaty and a phase 2 mRNA-based influenza vaccine, we’re lowering our fair value estimates for narrow-moat Pfizer to $36 from $38 and for no-moat BioNTech to $100 from $126.

• We’ve lowered our 2025 US covid vaccine revenue forecast to $1.8 billion from $2.2 billion, as we’re concerned that barriers to access, as well as confusion about access, will further limit US uptake.
• With the safety of coadministration of vaccines being questioned, we no longer assume that Pfizer/BioNTech and Moderna will be able to launch a differentiated covid/flu vaccine. We had previously thought this could help covid vaccination rates reach the nearly 50% level seen for influenza.