EquityResearch

USA|LargeCapPharmaMay20,2025

PFE/BNTX:updatedCOVIDvaccineapproval

frameworkisinlinewithexpectations

FDAsupdatedframeworkonCOVIDvaccineapprovalswasinlinewithour

expectations:immunogenicity-baseddatawillcontinuetobeusedforapproval

inadults65yrsinpersons6moofagew/oneormoreriskfactors.

Whiletheremainingpopw/oriskfactorswouldneedpbo-controlledstudies

forapproval,giventhatrevsprimarilycomefromthe65yrpop,wedont

expectthenewguidelinetohaveamaterialimpactonPFEs/BNTXsCOVIDrev

expectations.

InanarticlepublishedatNEJM,FDACommissionerDr.MartyMakaryandFDA’snewvaccinechief

Dr.VinayPrasadoutlinedthenewframeworkfortheCOVIDvaccineapprovalsgoingforward.We

highlightthefollowing:

#1)COVIDvaccineswillcontinuetogetapprovedbasedonimmunogenicitydatainolderadults

(65yrsold)inpersonswithriskfactors

ThearticlenotedthatFDAexpectstomakebenefit/riskdecisiononthebasisofimmunogenicity

datainolderadults(65years)andinpersonsabovetheageof6monthswithoneormorerisk

factorsthatputthemathighriskforsevereCovid-19outcomes.Thisissimilartotheexisting

approvalframeworkwithinthesimilarpopulation.NotethatthemajorityofcurrentCOVIDvaccine

uptakeandrevsessentiallycomefromthispopulation,andtheupdatedframeworkdoesnotbring

materialchangesintheapprovalprocesswithinthatpopulation.VRBPACisscheduledtomeet

onMay22todiscussthevariant-adaptedCOVID-19vaccinesforthe2025-2026vaccination

seasoninth