David Paul Morris | Bloomberg | Getty Images
PfizerA vaccine that protects infants against respiratory syncytial virus could win Food and Drug Administration approval by the end of this summer.
Pfizer said on Tuesday that the FDA would expedite its review of the vaccine. The agency is expected to make a decision on whether to release the missile in August, just before respiratory virus season.
The single-dose vaccine is administered to expectant mothers in the late second to third trimester of pregnancy. Antibodies induced by the injection are transferred to the fetus and protect infants against RSV from birth until the first six months of life, when they are most vulnerable.
The vaccine was 82% effective in preventing severe disease from RSV in newborns during the first 90 days of life, according to Pfizer clinical trial data. During the first six months of a child’s life, the injection was about 70% effective.
There is currently no vaccine to protect against 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.
RSV is the leading cause of infant hospitalization in the US, according to epidemiologists. Almost all children catch RSV by age two, and in most cases the virus causes a mild, cold-like illness. But infants face a higher risk of serious illness.
RSV can cause inflammation of the small airways in the lungs and pneumonia. Infants hospitalized with RSV often need oxygen support and IV fluids and may need to be put on a ventilator to support their breathing.
Symptoms in infants with RSV may include irritability, decreased activity and appetite, and pauses in breathing lasting longer than 10 seconds. A 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 catch RSV during the pandemic due to public health measures, and as a result did not have immunity to the previous infection as people began to socialize again, according to CDC officials.
Last fall, hospitals struggled to keep up with the large number of sick babies and children. The Children’s Hospital Association called the increase in RSV “unprecedented” and asked the Biden administration to do so declare a public health emergency during the peak in November.
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