Sanofi, AstraZeneca Report Promising RSV Pediatric Data Ahead of Pfizer Adcomm

BIOMARKER

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1. Sanofi and AstraZeneca's Phase IIIb HARMONIE trial demonstrates that nirsevimab reduces hospitalizations due to respiratory syncytial virus (RSV) by 83.21% and severe RSV-related lower respiratory tract disease (LRTD) by 75.71% in infants under 12 months.

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2. The RSV antibody candidate also lessens the overall incidence of all-cause LRTD hospitalization by 58.04%.

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3. HARMONIE is a large-scale European study evaluating the efficacy of a single nirsevimab dose at eliciting RSV protection, as compared with no immunization, with an estimated enrollment of 22,000 infants.

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4. Nirsevimab consistently demonstrated protection levels of around 80% against medically attended RSV infections across Phase III MELODY and Phase II/III MEDLEY trials and other Phase IIb data.

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5. Pfizer's RSV hopeful Abrysvo will be reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on May 18.

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6. Pfizer's Phase III MATISSE trial demonstrates a vaccine efficacy rate of 66.7% against RSV-associated lower respiratory tract illness (LRTI) with two or more symptoms and 85.7% against severe LRTI.

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7. The FDA will decide on Abrysvo's fate in the pediatric setting by August 2023.

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8. GSK won the FDA's first approval for an RSV vaccine for older adults aged 60 years and above last week.

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9. GSK had to suspend three maternal trials due to safety concerns in February 2020, making Pfizer and Sanofi/AstraZeneca the frontrunners in the RSV vaccine race for kids.

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10. Nirsevimab is an investigational long-acting antibody that induces passive immunity against RSV by binding to the part on the virus that it uses to attach to its target cells.

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