USA — Food and Drug Administration advisers have given their endorsement for administering an experimental Pfizer vaccine to pregnant individuals in order to protect infants against respiratory syncytial virus (RSV), despite concerns about the limited safety data available.
RSV is a significant cause of infant mortality globally, particularly among infants under six months of age. However, developing an effective vaccine against RSV has posed challenges for scientists over the years.
Pfizer’s vaccine aims to prevent severe illness in infants during their first six months of life by generating neutralizing antibodies that can be transferred from the mother to the baby in the womb.
Data from clinical trials analyzed by federal regulators demonstrated that the vaccine exhibited an efficacy rate of 82% in protecting infants during their first three months and a 69% efficacy rate in preventing severe illness at six months.
While the FDA’s panel of outside advisers unanimously agreed on the vaccine’s effectiveness, four panel members voted against its safety due to the insufficient data available.
Some advisers expressed concerns about potential risks of preterm births, citing the decision by GlaxoSmithKline to halt an RSV vaccine trial last year due to similar safety concerns.
However, Pfizer officials stated that there is currently no definitive evidence indicating an increased risk.
Holly Janes, a biostatistician at the Fred Hutchinson Cancer Center, and other panel members raised questions about the optimal timing for administering the vaccine, emphasizing the need for further clarity.
Janes expressed unease about relying on post-marketing surveillance studies instead of comprehensive trial data to confirm the vaccine’s safety.
Amanda Cohn, the CDC director of the division of birth defects and infant disorders, who voted in favor of safety, expressed worries about the FDA’s ability to establish a robust post-marketing surveillance system to monitor maternal health outcomes.
RSV poses a significant burden on pediatric healthcare, particularly during the first few weeks and months of a child’s life when their underdeveloped airways make them highly susceptible to the virus’s effects.
Children’s hospitals have experienced overwhelming cases of respiratory infections during previous RSV seasons.
Although RSV-related deaths among children in the United States are rare, estimated between 100 and 300 annually, the overall impact on healthcare systems is substantial.
RSV treatment costs nearly US$710 million per year, with public sources covering more than half of the medical expenses for infant RSV cases, as reported in the Journal of Infectious Diseases.
In a separate development, the FDA recently approved GlaxoSmithKline’s RSV vaccine for individuals aged 60 and older, another high-risk group. An FDA decision regarding Pfizer’s vaccine for the same age group is expected at the end of May.
The pressure RSV places on pediatric healthcare is significant, and until now, the only available tool to combat it has been a monoclonal antibody called palivizumab, sold as Synagis.
However, this antibody requires monthly injections, costing approximately US$1,800 per dose (wholesale acquisition cost), and is reserved for the highest-risk babies.
Consequently, there is great excitement about the possibility of another tool, such as Pfizer’s vaccine, which is expected to be substantially more affordable and could be used more widely.
Moreover, Sanofi has submitted a license application to the FDA for a long-lasting antibody therapy designed to be administered at birth, providing protection against RSV for infants in their first year of life.
This therapy is also anticipated to receive approval later this year, presenting another potential solution in the fight against RSV.
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