Nirsevimab is a recombinant human IgG1κ monoclonal antibody directed against the F protein of the respiratory syncytial virus (RSV) in its prefusion conformation. It is a long-acting antibody that has been modified by a triple amino acid substitution (YTE) in the Fc region to prolong its serum half-life.
It is a new treatment developed for the prevention of RSV infection in infants and young children at increased risk of severe disease. Galicia pioneeringly included this monoclonal antibody in the immunization schedule.
Monoclonal antibodies are generated by a complex process in which specialized cells, usually mouse cells or hybridoma cells, are engineered and fused to create a hybrid cell line that produces a specific type of antibody in large quantities. These hybrid cells are grown in a controlled environment, such as a bioreactor, where they multiply and secrete the desired antibody. They are then purified and genetically engineered to ensure consistency and efficacy. The resulting monoclonal antibodies are highly specific for a particular target, in this case respiratory syncytial virus (RSV).
Beyfortus
The Xunta de Galicia has awarded the successive supply of the monoclonal antibody nirsévimab (Beyfortus®) against respiratory syncytial virus. The winner is the pharmaceutical company Sanofi – Aventis SA for 3.36 million euros, according to what has just been published by the Autonomous Administration Contracting Platform.
SERGAS thus goes one step further in fulfilling its promise. This spring the Government of Galicia said that the country will become the pioneer among the autonomous regions by integrating the innovative monoclonal antibody.
This antibody is intended to prevent the spread of the respiratory syncytial virus (RSV), which affects 90% of infants under two years of age. RSV can cause bronchial disorders and pneumonia. The Xunta argues that these problems generated around 1,000 hospitalizations in Galicia with an average stay of six daysas well as more than 10,000 annual pediatric consultations.
The efficacy of the monoclonal antibody nirsevimab in protecting against RSV infection has been proven by international authorities in the United States and the EU. According to a clinical analysis, this antibody dramatically reduced the risk of hospitalization due to RSV by 90%. In addition, the risk of death associated with RSV also decreased by 80%.
SIDE EFFECTS OF THE VACCINE
The purchase was executed through a tender from the General Directorate of Public Health of Galicia. The announced plan is to begin its distribution during the fall, in anticipation of the season with the greatest viral impact.
Nirsévimab is generally well tolerated. The most common side effects are pain at the injection site, fever, chills, headache, fatigue, and diarrhea.
The inclusion of the monoclonal antibody nirsevimab in the Galician vaccination scheme represents an important advance in the prevention of RSV.
In addition to the nirsevimab monoclonal antibody, in recent years Galicia has added other vaccines to the immunological calendar. These vaccines include immunization against meningococcus B for infants from two months of age, the HPV vaccine for boys 12 years of age, and the quadrivalent influenza vaccine for all children under five years of age.
2023-08-08 11:59:00
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