In a significant development in the fight against Respiratory Syncytial Virus (RSV), the U.S. Centers for Disease Control and Prevention’s (CDC) advisors have recently granted their approval for the use of Pfizer’s RSV vaccine in pregnant women in the mid-stage of their third trimester. The decision, reached with an 11 to 1 majority vote, allows for the prescription of the vaccine from September through January.
Dr. Katherine Poehling, a distinguished member of the panel and a professor at the Wake Forest School of Medicine, expressed her enthusiasm, stating, “RSV has been a difficult disease with just supportive care treatment because there have been no options so today is an exciting day.”
This breakthrough follows the U.S. Food and Drug Administration’s endorsement of the RSV vaccine last month. Designed to safeguard against lower respiratory tract infections and severe RSV-related illnesses in infants up to six months old, the vaccine addresses a critical healthcare need.
Given RSV’s seasonal prevalence, peaking in winter after emerging in autumn, a year-round vaccination regimen may not be as beneficial for infants born between April and September. In such cases, the antibody therapy nirsevimab from Sanofi and AstraZeneca may be considered.
Alarming statistics reveal that between 58,000 to 80,000 children under the age of five are hospitalized annually in the U.S. due to RSV. Pfizer’s vaccine, alongside GSK’s counterpart, received approval for use in individuals aged 60 and above back in May and is readily accessible across the nation. Priced at $295 per dose, the maternal shot mirrors the cost for older adults. Pfizer intends to implement a tiered pricing approach for the vaccine outside the U.S.
Earlier concerns were raised during an advisory meeting in May, linking a higher incidence of preterm births among those who received Pfizer’s vaccine compared to those who received a placebo. The FDA, however, concluded that the disparity did not attain statistical significance, potentially attributable to chance.
The emergence of RSV infections, concurrent with an upswing in COVID transmissions and an unusually early onset of flu season, has stoked fears of a potential ‘tripledemic’ sweeping across the United States. The CDC anticipates that total hospitalizations stemming from these three diseases will parallel last year’s figures. This fall marks the inaugural availability of a vaccine offering protection against all three ailments.
The CDC panel’s resounding endorsement of Pfizer’s RSV vaccine for expectant mothers has been met with widespread enthusiasm, marking a crucial stride towards fortifying the defense for newborns against this debilitating virus.
Source: Reuters
