Clinical trial data revealed that Pfizer’s RSV (respiratory syncytial virus) vaccine has shown to be very effective in protecting newborn babies if the shot is administered to pregnant mothers later in the pregnancy.
The respiratory syncytial virus can be dangerous for infants below the age of 6 months, despite being a common virus. Symptoms are usually similar to that of a mild cold. The data from Pfizer revealed that the vaccine was over 80% effective at the prevention of severe lower respiratory tract sickness in the first three months of the child’s life. Such illnesses require breathing aids and hospitalization. According to the data, the vaccine was 70% effective in preventing severe lower respiratory tract sickness in the first six months.
Pfizer said that an application would be submitted to the FDA (Food and Drug Administration) for the vaccine’s approval by the end of the year. The results will be submitted for peer review, according to Pfizer.
Pfizer’s head of vaccine development Annaliesa Anderson said that the company’s RSV vaccine is the first to prove that it can protect newborn babies against the severe RSV instantly following the birth.
The pregnant mother receives the shot in a single dose in the later trimesters. The company’s clinical trial had 7,400 pregnant women all aged under 50. According to Pfizer, no safety concerns were noticed for the baby or mother as the vaccine was endured well. For additional safety, the baby was monitored for a minimum of one year while the mother was monitored for half a year post-delivery.
The vaccine showed a 57% effectiveness rate in preventing lower respiratory tract infections in the first three months of the baby’s life. Usually, these infections require a visit to the doctor. According to Pfizer, although this result is clinically significant, it failed to reach the statistical landmark that was set for the clinical trial’s success.
According to CDC (Centers for Disease Control and Prevention), up to 2% of the babies that catch RSV below the age of 6 months are hospitalized. To provide breathing assistance, they may need intubation or even a mechanical ventilator in some cases.
A warning was given by the CDC regarding RSV already reaching extreme levels in a few areas. CDC estimated that about 58,000 kids below the age of 5 years are hospitalized yearly due to the virus. Symptoms of the virus are loss of appetite, cough that can grow into wheezing, and runny nose. RSV may or may not have fever as a symptom.
The CDC says that while the symptoms are prevalent for toddlers, for babies below the age of six months, the symptoms may be more delicate and subtle. Pausing while breathing, irritability, and reduced appetite and activity all point toward the infant having RSV.