Pfizer RSV vaccine for babies could get FDA approval this summer

David Paul Morris | Bloomberg | Getty Images

pfizerA vaccine that protects infants from respiratory diseases could be approved by the Food and Drug Administration by the end of this summer.

On Tuesday, Pfizer said the FDA is reviewing the vaccine on an expedited basis. The agency is expected to make a decision to withdraw the vaccine in August, shortly before the start of the respiratory virus season.

A single-dose vaccine is given to expectant mothers at the end of the second or third trimester of pregnancy. The vaccine-induced antibodies are transferred to the fetus and protect infants from RSV from birth until the first six months of life, when they are most vulnerable.

The effectiveness of the vaccine in preventing severe RSV in newborns during the first 90 days of life was 82%. according to Pfizer clinical trials. The vaccine was about 70% effective during the first six months of a child’s life.

There is currently no vaccine to protect against RSV. Babies under 6 months old are also too young to receive most of the vaccines 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 become infected with RSV by age 2, and in most cases the virus causes a mild illness similar to a cold. But babies face a higher risk of severe illness.

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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 intravenous fluids, and may need to be connected to a ventilator to support their breathing.

Symptoms in infants with RSV may include irritability, decreased activity and appetite, and pauses in breathing for more than 10 seconds. The virus does not always cause fever.

The RSV exploded last fall as people largely stopped wearing masks and practicing social distancing. Pandemic Covid-19 lightweight. Many children did not contract RSV during the pandemic due to public health measures and, as a result, were not immune from prior infection as people began to socialize again. according to CDC representatives.

Hospitals struggled to cope with the large number of sick babies and children last fall. The Children’s Hospital Association called the RSV surge “unprecedented” and asked the Biden administration to declare a public health emergency during the peak in November.

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