The Respiratory Syncytial Virus (RSV) has long been a concern, causing widespread respiratory illnesses. Its origins trace back to a 1955 lab study involving monkeys at the Walter Reed Army Institute.
Over time, RSV became endemic in humans, particularly affecting infants during their initial exposure. The history of RSV vaccines is marked by six decades of setbacks, with early attempts exacerbating infections. This led both GSK and Pfizer to embark on a new endeavor to develop a non-mRNA-based RSV vaccine with a stabilized antigen, tailored for expectant mothers.
Interestingly, GSK and Pfizer's RSV vaccines share strikingly similar compositions.
However, administering these vaccines to pregnant mothers has raised concerns about increased rates of premature births and infant mortality.
GSK eventually withdrew its product due to safety apprehensions, while Pfizer pressed on for approval, remaining tight-lipped about the disparities in safety profiles.
The FDA and CDC chose to overlook the safety signal indicating elevated preterm birth rates, now advocating the vaccine for all pregnant women.
This begs the question: What might be the repercussions if the RSV vaccine were universally administered in the United States?
In 2021, the U.S. witnessed 3,664,292 registered births. Annually, RSV-related hospitalizations for children under five hover between 58,000 and 80,000, with 100 to 300 tragic deaths. Even granting maximum leeway to CDC figures, the imbalance becomes glaring.
A 2% surge in preterm births could translate to an additional 73,285 premature deliveries, a concerning prospect given the associated risks. GSK's study indicated a concerning trend, with 238 preterm births in the vaccine group versus 86 in the placebo group. Furthermore, neonatal deaths skewed unfavorably towards the vaccinated cohort.
Pfizer's RSV vaccine, at best, might curtail around 57% of total RSV hospitalizations among children under five, a range between 33,060 and 45,600 cases. Paradoxically, it's projected to induce approximately 73,000 premature births, potentially causing harm to developing fetuses.
Considering that RSV-related deaths among children under five are relatively rare, the balance tilts. Pfizer's vaccine, by conservative estimates, could elevate infant mortality by 20%, culminating in an additional 4,000 deaths annually.
In light of these figures, a pivotal question arises: How can a vaccine, albeit aimed at saving lives, justify endangering so many others? The precarious balance between potential benefits and risks calls for a rigorous reevaluation of the RSV vaccine's approval, emphasizing a thorough understanding of the consequences at hand.
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