USA — The U.S. Centers for Disease Control and Prevention (CDC) has announced their endorsement of Pfizer’s respiratory syncytial virus (RSV) vaccine for expectant mothers in their third trimester.
This critical development aims to safeguard newborns from severe RSV-related illnesses.
The CDC’s recommendation follows a resounding 11 to 1 vote by a panel of advisers, approving the vaccine’s use for women between 32 and 36 weeks pregnant from September through January.
This landmark decision sets the stage for the nation’s inaugural maternal vaccine against the seasonal respiratory virus.
Dr. Mandy Cohen, CDC Director, heralded this milestone, saying, “This is another new tool we can use this fall and winter to help protect lives.”
Pfizer’s RSV vaccine garnered approval from the U.S. Food and Drug Administration (FDA) in the previous month for expectant mothers within the same 32 to 36-week window of pregnancy.
It offers protection against lower respiratory tract infections and severe infant illnesses, extending its shield until infants reach six months of age.
Dr. Katherine Poehling, an esteemed member of the CDC advisory panel and a professor specializing in pediatrics and epidemiology, hailed this momentous day, remarking, “RSV throughout my career has been a difficult disease with just supportive care treatment because there have been no options so today is an exciting day.”
This strategic decision to administer the vaccine during late pregnancy intends to mitigate potential risks of preterm births and associated complications, as elucidated by medical experts on the panel.
RSV, a prevalent respiratory virus, typically manifests as mild cold-like symptoms but can escalate into severe illnesses requiring hospitalization. Its prevalence aligns with seasonal patterns, peaking during the winter months across most of the U.S.
Considering the seasonality of RSV, Dr. Sarah Long, a panel member and pediatrics professor, emphasized, “Year-round administration could not benefit children born in April through September.”
For such cases, Sanofi and AstraZeneca’s antibody therapy, nirsevimab, offers preventive measures against RSV for infants and toddlers.
Government data reveals that an estimated 58,000 to 80,000 children under five years are hospitalized annually due to RSV infections in the U.S.
Pfizer’s maternal vaccine, together with a counterpart produced by GSK, received U.S. approval for individuals aged 60 and above in May and is already accessible nationwide.
Pfizer confirmed that the list price for the maternal shot matches the cost for older adults at US$295 per dose, while international pricing will follow a tiered structure.
Notably, during a May advisory meeting, FDA staff raised concerns about a slightly higher rate of preterm births among participants who received Pfizer’s vaccine in clinical trials compared to those who received a placebo.
However, the FDA clarified that this difference did not appear to be statistically significant and could have occurred by chance.
With a surge in RSV cases coinciding with increased COVID transmission and an earlier-than-expected flu season, the prospect of a ‘tripledemic’ looms large across the United States.
The CDC anticipates a comparable hospitalization rate to the previous year due to these three respiratory illnesses.
For the first time, this autumn will witness the availability of vaccines to combat all three diseases, marking a monumental step forward in safeguarding public health.
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