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Pfizer to seek approval for RSV vaccine

As parents and doctors deal with three significant illnesses — COVID-19, flu and respiratory syncytial virus or RSV — pharmaceutical company Pfizer says it may seek approval for a new vaccine to prevent RSV by the end of the year.

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RSV usually causes cold-like symptoms that are normally mild but can become serious in older adults and infants, according to the Centers for Disease Control and Prevention.

Most people are better with a week or two.

Symptoms of RSV include:

  • Runny nose.
  • Decreased appetite.
  • Coughing.
  • Sneezing.
  • Fever.
  • Wheezing.

The symptoms, according to the CDC, develop in stages.

Young infants may only show symptoms of irritability, decreased activity and breathing difficulties. The CDC estimates that all children would have had an RSV infection by the time they turn 2 years old.

Pfizer is now looking to prevent RSV by giving pregnant women the vaccine that will allow the expectant mothers to make antibodies that will then be shared with their unborn child through the placenta and provide protection to the baby after they’re born, CNN reported.

Pfizer gave 7,400 pregnant women a single vaccine dose or a placebo either in the late second trimester or third trimester, and the babies were followed for at least a year after they were born, NBC News reported.

Those who were given the vaccine showed about an 80% effective rate at preventing severe RSV in the first three months of a baby’s life, CNN reported.

Pfizer said the vaccine provides protection for the baby for at least six months, NBC News reported.

The study results, which Pfizer plans to submit to the Food and Drug Administration by the end of the year, were published in a Pfizer news release but have not been peer reviewed or published in a medical journal, NBC News reported.

Dr. Ofer Levy, director of Precision Vaccines Program at Boston Children’s Hospital, said the findings are promising but since the information was via a press release and he hasn’t seen the raw data, he can’t make a firm conclusion. However, he did say that since it is a passive immunization — where the mothers pass on the protection to their babies — the children may need an additional vaccine dose, NBC News reported.

The FDA has already cleared one hurdle earlier this year to speed up the approval process when it designated the RSV vaccine a breakthrough therapy.




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