Favorable Nonclinical Safety Profile of RSVpreF Bivalent Vaccine in Rats and Rabbits DOI Creative Commons
Jun Zhou, Christopher Bowman,

Vicki R. Markiewicz

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 13(1), P. 26 - 26

Published: Dec. 31, 2024

Background: Respiratory syncytial virus (RSV) infections usually cause mild, cold-like symptoms in most people, but are a leading infectious disease causing infant death and hospitalization can result increased morbidity mortality older adults at-risk individuals. Pfizer has developed Abrysvo®, an unadjuvanted bivalent recombinant protein subunit vaccine containing prefusion-stabilized fusion (F) proteins representing RSV A B subgroups (RSVpreF). It is the only approved for both maternal immunization to protect infants active of (≥60 years) 18–59-year-old individuals with high-risk conditions prevention disease. Methods: Nonclinical safety studies, including repeat-dose toxicity (RDT) study rats combined developmental reproductive (DART) rabbits, were conducted support early clinical development. Study designs parameters evaluated these studies consistent principles practices as outlined relevant regulatory guidelines. RSVpreF vaccine, or without Al(OH)3, was administered intramuscularly (IM) at 2× human dose animals studies. Results: Locally tolerated, reversible, inflammatory responses injection sites draining lymph nodes observed typical findings following vaccination. No effect RSVpreF, on female fertility embryo–fetal postnatal survival, growth, development DART study. In robust immune antigens observed, especially Al(OH)3 formulation. Conclusions: well-tolerated locally systemically any adverse effects endpoints.

Language: Английский

Experience of patients in Germany with the post-COVID-19 vaccination syndrome DOI Creative Commons

Kerstin Wüstner

Open Health, Journal Year: 2025, Volume and Issue: 6(1)

Published: Jan. 1, 2025

Abstract The coronavirus disease 2019 (COVID-19) pandemic seems to have been overcome and replaced by other issues that influence risk perception, communication, behaviour. However, for some people, the aftereffects continue reverberate, either because they suffer from “long COVID” or side effects of COVID-19 vaccination. aim this article is examine experiences patients in Germany who attribute health problems A literature search was conducted using four engines, but no publications were found shed light on topic. This indicates there remains a gap research landscape. discussion considers what factors might patient experience contribute lack

Language: Английский

Citations

0
Favorable Nonclinical Safety Profile of RSVpreF Bivalent Vaccine in Rats and Rabbits DOI Creative Commons
Jun Zhou, Christopher Bowman,

Vicki R. Markiewicz

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 13(1), P. 26 - 26

Published: Dec. 31, 2024

Background: Respiratory syncytial virus (RSV) infections usually cause mild, cold-like symptoms in most people, but are a leading infectious disease causing infant death and hospitalization can result increased morbidity mortality older adults at-risk individuals. Pfizer has developed Abrysvo®, an unadjuvanted bivalent recombinant protein subunit vaccine containing prefusion-stabilized fusion (F) proteins representing RSV A B subgroups (RSVpreF). It is the only approved for both maternal immunization to protect infants active of (≥60 years) 18–59-year-old individuals with high-risk conditions prevention disease. Methods: Nonclinical safety studies, including repeat-dose toxicity (RDT) study rats combined developmental reproductive (DART) rabbits, were conducted support early clinical development. Study designs parameters evaluated these studies consistent principles practices as outlined relevant regulatory guidelines. RSVpreF vaccine, or without Al(OH)3, was administered intramuscularly (IM) at 2× human dose animals studies. Results: Locally tolerated, reversible, inflammatory responses injection sites draining lymph nodes observed typical findings following vaccination. No effect RSVpreF, on female fertility embryo–fetal postnatal survival, growth, development DART study. In robust immune antigens observed, especially Al(OH)3 formulation. Conclusions: well-tolerated locally systemically any adverse effects endpoints.

Language: Английский

Citations

0