Pfizer's RSV Vaccine Abrysvo Achieves Positive Phase III Results, Paving the Way for Expansion to Adults Aged 18–59

Apr 10, 2024 08:31 CST Updated 08:31

Pfizer

Pharmaceutical R&D Developer

April 9,PfizerAnnouncement of EvaluationRespiratory Syncytial Virus (RSV)VaccinePF-06928316 (Trade Name:Abrysvo) Immunogenicity and Safety in High-Risk Adult Populations with RSV InfectionThe pivotal Phase III MONeT study met its primary endpoint.

This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluateAbrysvoCompared with placebo18-59Prone to illness at the age ofCaused by RSV infectionLower Respiratory Tract Diseases(LRTD) HighRiskAdultsPreventive Effect in Populations. Among them,Sub-study A was a double-blind study that enrolledChronic disease group (n=681), participants received a single dose (120µg) vaccination;Sub-study B is an open-label study, enrolling immunocompromised populations (n=200),SubjectPatientReceived two doses（120µg）Vaccination。

The results showed that the study met its co-primary immunogenicity endpoints and primary safety endpoint:

AbrysvoThe neutralization response to RSV-A and RSV-B is non-inferior in Phase III.The level in the RENOIR study.
Vaccination withVaccineCompared to before, the subjects were vaccinatedAbrysvoOne month later, the serum neutralization titers for RSV-A and RSV-B increased at least fourfold.
During the trial period,AbrysVO'sWell tolerated, with safety results consistent with previous studies.

In addition, Pfizer inA diverse group was recruited in the study.These data also reflect the diversity of the U.S. population and can represent the balance under basic medical conditions.

Pfizer plans to submit these data to the regulatory authorities and apply forAbrysApplicable Population of VOExpanded from adults aged 60 and above to those aged 18 and above.

AbrysvoIt is a bivalent RSV vaccine that was first approved for marketing in the United States in May 2023, used to prevent RSV infection in people over 60 years old.In August of the same year, the vaccine added a new applicable population, namely pregnant women,To prevent infants from birth to 6 months old from RSV infection.

In addition to the high-risk adult population, Pfizer is also evaluatingAbrysvoIn high-risk children and adolescent populations (2-17Year) in preventive effects.

RSVIs an infectious virus and also the cause ofCommon Causes of Respiratory Diseases.The virus can affect the lungs and breathing of those infected.Path, and canCan lead to young children, the elderly andCertainChronicPatients with ComplicationsSevere Disease.In the United States, RSV infections occur annually among the elderly.Approximately 6-16Ten ThousandExample PatientHospitalization and 6000-13000 patientsDeath.RSVThere are twoMain SubType——RSV-AAndRSV-B，These two sub-TypeWill cause respiratoryDisease, and can vary between different epidemicsSeasonCommon BetweenOr alternatePathogenic。

Studies have shown that,Suffering fromCertainChronicDisease(such as patients with asthma, diabetes, and chronic obstructive pulmonary disease)AdultsInfectionRSVAnd appearLRTDOrThe risk of hospitalization will alsoIncrease。In the United States,9.5%18-49 years oldAdultsSuffering from chronicDisease,24.3%50-64-Year-Old ElderlyPersonIt is also a chronic disease.Population，These people were infected with RSVAnd appearSevereThe risk of the disease is also high.However,Not yet availableUsed for18-59Adults agedRSVVaccine Approved for Marketing。

Currently, there are two RSV vaccines approved globally, the other one beingArexvy（GSK）。The market competition between the two vaccines is extremely intense.Abrysvo andARexvy generated sales of $8.9 billion and $15 billion respectively last year.From the current sales performance,Arexvy is still in a dominant position. WithAbrysvo's market penetration in pregnant women and the elderly population is continuously increasing, and its market share is likely to catch up or even surpass in the future.Arexvy。However,ModernaRSV VaccinemRNA-1345On the way to entering the market competition,And through RSV neutralizing antibodiesNirsevimab (Trade name:Beyfortus）Open the marketSanofiis also developing a nasal spray RSV vaccine (see:February 2024 | 15 Innovative Drugs Enter Phase III, 5 from Chinese Pharmaceutical Companies). The competition in the RSV track is becoming increasingly fierce.

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