The Food and Drug Administration (FDA) has granted approval for Pfizer’s vaccine designed to protect infants from respiratory syncytial virus (RSV), a leading cause of infant hospitalization in the U.S. While Pfizer’s RSV shot is already approved for older adults in the U.S., this marks the second treatment approved by the FDA to prevent RSV in infants and the first vaccine to do so. The vaccine employs maternal immunization, where pregnant mothers are vaccinated to pass protective antibodies to their fetuses.
Pfizer anticipates making the vaccine available to the public by the end of October or the beginning of November, which aligns with the onset of RSV season. This approach has the potential for significant public health impact, particularly after years of attempting to develop a vaccine to protect infants in their early months of life.
The FDA had previously approved an RSV monoclonal antibody from Sanofi and AstraZeneca for direct administration to infants. Pfizer’s vaccine, on the other hand, is administered to expectant mothers in their late second or third trimester. The single-dose vaccine generates antibodies that are transferred to the fetus, providing protection against RSV from birth through the first six months of life.
RSV typically causes mild symptoms resembling a cold, but it can result in severe infections for younger children and older adults. The virus leads to the deaths of hundreds of children under five and thousands of seniors each year.
Pfizer’s vaccine approval is based on phase three trial data demonstrating its efficacy. The shot was found to be nearly 82% effective in preventing severe RSV disease in newborns during the first 90 days of life and approximately 70% effective during the first six months. While some advisors raised concerns about safety due to a slightly higher rate of premature births among vaccinated mothers, Pfizer is set to conduct a post-marketing study to further assess these potential risks and complications. A pregnancy registry will also be established to monitor adverse events after vaccination.
Overall, Pfizer’s vaccine approval offers a promising step toward protecting infants from RSV and addressing a significant public health concern.
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