Pfizer RSV vaccine for infants could get FDA approval this summer

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pfizerA vaccine that protects infants against respiratory syncytial virus could receive Food and Drug Administration approval by the end of this summer.

Pfizer said on Tuesday that the FDA is rapidly reviewing the vaccine. The agency is expected to make a decision about clearing the shot in August, just before 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 triggered by the shot are passed to the fetus, and protect infants against RSV during the first six months of life, when they are most vulnerable.

According to Pfizer’s clinical trial data, the vaccine was 82% effective in preventing severe disease from RSV in newborns during the first 90 days of life. The shot was effective about 70% of the time during the first six months of a child’s life.

There is currently no vaccine to prevent RSV. Infants younger than six months are also too young to receive most of the shots recommended by the Centers for Disease Control and Prevention.

According to epidemiologists, RSV is the leading cause of hospitalization for infants in the US. Nearly all children contract RSV by the age of two, and in most cases the virus causes a mild, cold-like illness. But infants are at higher risk of severe disease.

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RSV can cause inflammation of the small airways in the lungs and pneumonia. Babies hospitalized with RSV often require oxygen support and IV fluids, and may need to be placed on a ventilator to help them breathe.

Symptoms in infants with RSV may include irritability, decreased activity and appetite, and pauses in breathing for longer than 10 seconds. Viruses do not always cause fever.

RSV exploded last fall as the public largely stopped wearing masks and practicing social distancing as the Covid-19 pandemic eased. According to CDC officials, many children did not become vulnerable to RSV during the pandemic due to public health measures, and consequently did not become immune to prior infection as people began to socialize again.

Hospitals were struggling to keep the large number of sick infants and children at last. The Children’s Hospital Association called the RSV surge “unprecedented” and called on the Biden administration to declare a public health emergency during the peak in November.

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