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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
If approved, Beyfortus (nirsevimab) would be the first and only single-dose passive immunization for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.
MEDI8897 (nirsevimab) is an investigational long-acting antibody aiming to protect all infants from birth entering their first RSV season with a single dose.x,xi,xii is designed to provide direct RSV protection to all infants via an antibody to help prevent LRTI caused by RSV.
Data confirmed Adjuvanted recombinant protein-based COVID-19 vaccine candidate’s universal potential to boost neutralizing antibodies 18- to 30-fold across all vaccine platform. Cohort 2 included 1,500 participants. VAT02 results will be published in a peer-reviewed journal.
Lead Product(s):
Adjuvanted Recombinant Protein-Based COVID-19 Vaccine
Results from prespecified pooled analysis of MELODY and Phase 2b MEDI8897 (nirsevimab) trials demonstrated an efficacy of 79.5% against medically attended LRTI, such as bronchiolitis or pneumonia, caused by RSV in infants born at term or preterm entering first RSV season.
Nirsevimab is the first investigational immunization designed to protect all infants across the RSV season with a single dose, showed a 74.5% reduction in lower respiratory tract infections caused by RSV requiring medical care in healthy infants.
Data from Phase 3 VAT08 and VAT02 efficacy study showed that two doses of Sanofi-GSK booster vaccine SP0253 or GSK4353001A (SARS-CoV-2 recombinant protein vaccine) generated an efficacy of 100%, 75%, 57.9% against severe COVID-19 disease.
Lead Product(s):
SARS-CoV-2 Recombinant Protein Vaccine,AS03
Preliminary results from the VAT0002 (SARS-CoV-2 Recombinant Protein Vaccine) clinical trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received or all age groups tested.
Lead Product(s):
SARS-CoV-2 Recombinant Protein Vaccine
Nirsevimab is a long-acting antibody, using AstraZeneca’s proprietary YTE technology, and being developed by AstraZeneca and Sanofi, with the potential to provide immunity directly to infants and offer immediate protection against RSV.
The Phase 3 study follows the interim Phase 2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates.
Lead Product(s):
SARS-CoV-2 recombinant protein vaccine
Nirsevimab reached its primary endpoint, achieving a statistically significant absolute reduction of LRTI caused by RSV in healthy preterm and term infants compared to placebo through a typical RSV season.