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Pfizer‘s vaccine, which protects infants from respiratory syncytial virus, could receive Food and Drug Administration approval by the end of this summer.
Pfizer said Tuesday the FDA is expediting review of the vaccine. The agency is expected to make a decision on whether to delete the shot in August, just ahead of the respiratory virus season.
The single-dose vaccine is given to expectant mothers in the late second to third trimester of their pregnancy. The antibodies raised by the injection are passed to the fetus and protect infants from RSV from birth through the first six months of life, when they are most vulnerable.
According to data from Pfizer’s clinical trial, the vaccine was 82% effective in preventing severe RSV disease in newborns in the first 90 days of life. The shot was about 70% effective in the baby’s first six months.
There is currently no vaccine to protect against RSV. Infants younger than 6 months are also too young to get most vaccinations recommended by the Centers for Disease Control and Prevention.
According to epidemiologists, RSV is the leading cause of hospitalization for infants in the United States. Almost all children become infected with RSV by age 2, and in most cases the virus causes a mild, cold-like illness. However, infants are at a higher risk of serious illnesses.
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RSV can cause inflammation of the small airways in the lungs and pneumonia. Infants hospitalized with RSV often require oxygen support and IV fluids, and may need to be put on a ventilator to support their breathing.
Symptoms in infants with RSV can include irritability, decreased activity and appetite, and pauses in breathing longer than 10 seconds. The virus does not always cause a fever.
RSV exploded last fall when the public largely stopped wearing masks and practicing social distancing as the Covid-19 pandemic eased. Many children did not contract RSV during the pandemic due to public health measures and, as a result, were not immune to previous infections when people started socializing again, according to CDC officials.
Hospitals struggled to keep up with the large number of sick babies and children last fall. The Children’s Hospital Association called the RSV surge “unprecedented” and called on the Biden administration to declare a public health emergency during the November peak.
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