Speaker Credentials
OMS-II
Speaker Credentials
BS
College
Dr. Kiran C. Patel College of Osteopathic Medicine, DO
Medical Specialty
Infectious Disease
Format
Poster
Start Date
November 2024
End Date
November 2024
Track
1
Abstract
Efficacy and safety profile of the maternal RSV vaccine, Abrysvo Dhanvi Patel1, Jyotsna Chawla2, Cyril Blavo3 Department of Medicine, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Clearwater, USA Department of Foundational Sciences, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Clearwater, USA Department of Public Health, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Clearwater, USA Abstract: Objective: To study the vaccine efficacy and safety of the FDA-approved maternal respiratory syncytial virus (RSV) vaccine, Abrysvo, manufactured by Pfizer. Background: RSV-associated lower respiratory infections are the leading cause of hospitalizations in infants globally. Abrysvo is a recombinant protein vaccine that targets RSV’s pre-fusion protein and prevents it from fusing to host cells. When administered in pregnant women between 32 to 36 weeks of gestation, the transplacental cross of antibodies confers passive immunity to the fetus. Methods: Pfizer's phase 3 clinical trial, MATISSE (Maternal Immunization Study for Safety and Efficacy), was conducted to evaluate the efficacy and safety. The trial enrolled pregnant women under 49 years of age from 18 countries with uncomplicated, singleton pregnancies at 24 to 36 weeks of gestation to assess any adverse events. Additionally, data from the Vaccine Adverse Event Reporting System (VAERS), managed by the CDC and FDA, was analyzed looking at reports from vaccine recipients between the ages of 0 and 39.
Results: The MATISSE trial demonstrated that Abrysvo effectively prevented medically attended severe RSV-associated lower respiratory tract illness in infants, with an efficacy of 81.8% within 90 days of birth and 69.4% within 180 days of birth. Common adverse events reported include preterm birth, low birth weight, and pre-eclampsia. Similarly, VAERS indicated that preterm births and pre-eclampsia were the most frequently reported. Conclusion: Abrysvo has been proven to be safe and efficacious with the benefits of RSV prevention in infants outweighing the adverse effects. Grants: No financial sponsorships to report Keywords: Respiratory syncytial virus, vaccine, adverse events, pregnancy, FDA approved, Abrysvo
Included in
Efficacy and safety profile of the maternal RSV vaccine, Abrysvo
Efficacy and safety profile of the maternal RSV vaccine, Abrysvo Dhanvi Patel1, Jyotsna Chawla2, Cyril Blavo3 Department of Medicine, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Clearwater, USA Department of Foundational Sciences, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Clearwater, USA Department of Public Health, Dr. Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Clearwater, USA Abstract: Objective: To study the vaccine efficacy and safety of the FDA-approved maternal respiratory syncytial virus (RSV) vaccine, Abrysvo, manufactured by Pfizer. Background: RSV-associated lower respiratory infections are the leading cause of hospitalizations in infants globally. Abrysvo is a recombinant protein vaccine that targets RSV’s pre-fusion protein and prevents it from fusing to host cells. When administered in pregnant women between 32 to 36 weeks of gestation, the transplacental cross of antibodies confers passive immunity to the fetus. Methods: Pfizer's phase 3 clinical trial, MATISSE (Maternal Immunization Study for Safety and Efficacy), was conducted to evaluate the efficacy and safety. The trial enrolled pregnant women under 49 years of age from 18 countries with uncomplicated, singleton pregnancies at 24 to 36 weeks of gestation to assess any adverse events. Additionally, data from the Vaccine Adverse Event Reporting System (VAERS), managed by the CDC and FDA, was analyzed looking at reports from vaccine recipients between the ages of 0 and 39.
Results: The MATISSE trial demonstrated that Abrysvo effectively prevented medically attended severe RSV-associated lower respiratory tract illness in infants, with an efficacy of 81.8% within 90 days of birth and 69.4% within 180 days of birth. Common adverse events reported include preterm birth, low birth weight, and pre-eclampsia. Similarly, VAERS indicated that preterm births and pre-eclampsia were the most frequently reported. Conclusion: Abrysvo has been proven to be safe and efficacious with the benefits of RSV prevention in infants outweighing the adverse effects. Grants: No financial sponsorships to report Keywords: Respiratory syncytial virus, vaccine, adverse events, pregnancy, FDA approved, Abrysvo