Title: FDA Approves First Vaccine to Protect Newborns from Respiratory Syncytial Virus
Subtitle: Pfizer’s Abrysvo Provides Protection to Infants for Six Months
Date: [Insert Date]
In a significant development, the US Food and Drug Administration (FDA) has granted approval for Pfizer’s vaccine, Abrysvo, which protects newborns from respiratory syncytial virus (RSV). This marks the first vaccine of its kind to provide protection to infants against this common and potentially life-threatening illness. Abrysvo is administered to mothers late in their pregnancies and offers protection to infants for the first six months of their lives.
A trial involving over 7,000 pregnant individuals and their infants revealed that Abrysvo significantly reduced the risk of infants requiring medical attention or hospitalization due to RSV. Often hitting hardest during the winter months, RSV is a major cause of hospitalization in both infants and the elderly. The previous RSV season was longer and more severe than usual, overwhelming children’s hospitals.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized the importance of this approval as it provides a much-needed option for healthcare providers and expectant individuals to protect infants from this potentially life-threatening disease. RSV is known to cause severe illness in children, with infants being among those at the highest risk.
After years of study and failed attempts, there are now several offerings available to protect against RSV, including the recently approved antibody shot for all infants after birth and new vaccines for individuals aged 60 and older. Pfizer’s Abrysvo stands out as the first and only maternal immunization that offers immediate protection to newborns through six months from RSV, marking a significant milestone for public health and the scientific community overall.
Pfizer estimates that if the vaccine were universally applied, maternal vaccination could prevent up to 16,000 hospitalizations and over 300,000 doctor visits annually due to RSV. However, it should be noted that the vaccine does not provide long-term protection. In the first three months after birth, Abrysvo was 82% effective at preventing severe RSV disease and 57% effective at avoiding doctor visits related to RSV infection. By six months, the effectiveness dropped to 69% for severe RSV disease and 51% for preventing doctor visits due to RSV-related breathing problems. After six months, the vaccine was no more effective than a placebo in preventing visits to the doctor.
Earlier this year, the FDA’s vaccine advisers unanimously voted in favor of the vaccine’s effectiveness and largely supported its safety. Data analysis showed a slightly higher proportion of preterm births among babies whose mothers received the RSV vaccine compared to those who received a placebo. The slight difference was not considered statistically significant and may be attributed to chance.
To ensure ongoing safety evaluation, Pfizer plans to conduct a large post-market safety study in which they will analyze data from large databases, including Medicaid data. This study will evaluate safety endpoints, including preterm birth, in individuals who receive the vaccine.
Additionally, Pfizer is studying the effectiveness of Abrysvo in higher-risk children aged 2 to 18 and adults aged 18 to 60, who have underlying medical conditions or weakened immune systems and are at a greater risk of contracting RSV.
The approval of Abrysvo represents a major breakthrough in protecting newborns from RSV. It offers new hope in the fight against this common and potentially severe illness, providing healthcare providers and expectant individuals with a valuable tool to safeguard newborns in their first months of life.
CNN’s Jen Christensen and Amanda Sealy contributed to this report.