Pfizer has just received approval from the European Commission (EC) for its groundbreaking vaccine, Abrysvo. This vaccine, targeting the respiratory syncytial virus (RSV), is set to revolutionize protection for both vulnerable infants and older adults. The approvals are for two critical use cases:
Infant Protection Through Maternal Immunization: Abrysvo offers a shield against lower respiratory tract disease (LRTD) caused by RSV in infants from birth until six months old. This safeguard is achieved through maternal immunization during pregnancy, setting the stage for a healthier start in life.
Elderly Defense: Recognizing the vulnerability of older adults, the vaccine is also authorized for active immunization of individuals aged 60 years and above. This initiative aims to prevent the onset of LRTD due to RSV in this age group.
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“The approval of ABRYSVO in Europe marks significant progress in the scientific community’s efforts to provide meaningful protection against RSV, a common respiratory virus that could potentially be severe and even life-threatening, especially for infants and older adults. Last year’s significant number of newborns, children, and adults being hospitalized across Europe demonstrated the immense need for protection against severe RSV cases. The approval of the vaccine for both older adults and infants through maternal immunization is a triumph for public health and we hope to see a tremendous impact for future seasons.”
– Annaliesa Anderson, Ph.D., Senior Vice President and Head Vaccine Research and Development, Pfizer
The path to this momentous achievement was paved by a recent favorable evaluation from the Committee for Medicinal Products for Human Use (CHMP), validating the vaccine’s safety and efficacy. The authorization extends across all 27 EU member states, alongside Iceland, Liechtenstein, and Norway, offering a broad reach to maximize protection.
Abrysvo marks a significant milestone as the inaugural licensed vaccine tailored and rigorously studied for maternal immunization. Expectant mothers in the EU can now consider administering a single vaccine dose between weeks 24 and 36 of gestation, reinforcing protection for both them and their newborns. Moreover, Abrysvo has been exhaustively studied among adults aged 60 and above, with the authorization encompassing single-dose application for this demographic as well.
The pivotal decision by the EC is underpinned by comprehensive evidence derived from two Phase 3 clinical trials: RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) and MATISSE (MATernal Immunization Study for Safety and Efficacy).
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The RENOIR study (NCT05035212) conducted globally employed a randomized, double-blind, placebo-controlled approach to assess the efficacy, immunogenicity, and safety of a solitary vaccine dose in individuals aged 60 years and older. Meanwhile, the MATISSE trial (NCT04424316) followed a similar methodology to ascertain the effectiveness, safety, and immunogenicity of RSVpreF in preventing LRTD, including severe cases, in infants born to vaccinated healthy individuals during pregnancy.
Crucially, the outcomes of both RENOIR and MATISSE have been documented in The New England Journal of Medicine, underscoring the scientific rigor and transparency of the process. The RENOIR study remains ongoing, with the collection of efficacy data spanning the second RSV season in the research.
RSV, a highly contagious virus, imposes a substantial global health burden. It is a primary cause of respiratory illnesses, particularly affecting the lungs and airways. The statistics are alarming: in the EU, the virus leads to around 245,000 yearly hospitalizations for children below five years, with infants under one year at greatest risk. Furthermore, older adults also face significant challenges, with over 270,000 hospitalizations and about 20,000 deaths attributed to RSV among those aged 60 years and older annually.
Pfizer’s Abrysvo stands as a beacon of hope, offering targeted protection for the most vulnerable among us and potentially altering the course of RSV-related health outcomes. This groundbreaking achievement not only showcases the power of scientific innovation but also promises a brighter, healthier future for generations to come.
