A new study from Real-World has found that the respiratory syncytial virus (RSV) vaccine is safe when given to pregnant women.
This was revealed by Gavi, the vaccine alliance, on its website on Wednesday.
The study found that thousands of women who received the RSV vaccine to protect their babies said the vaccine was safe.
Respiratory syncytial virus vaccine
According to the report, RSV is a leading cause of lower respiratory tract infections among young children, especially those under six months of age who are at high risk of severe illness and death.
She noted that in 2019, many underage children in low-income countries were hospitalized due to the vaccine.
“In 2019 alone, it was responsible for some 3.6 million hospital admissions and 101,400 deaths among children under five, with low- and middle-income children disproportionately affected by vaccination,” he said.
The study shows that maternal vaccination against RSV during pregnancy allows mothers to protect their babies against the virus during their most vulnerable early months, while reducing their own risk of infection.
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Maternal RSV vaccine
The study found that the RSVpreF vaccine (Abrysvo) made history by being the first to be approved for use during pregnancy, protecting babies from lower respiratory tract disease caused by RSV by transferring protective antibodies across the placenta.
The group said the U.S. Centers for Disease Control and Prevention (CDC) has recommended that eligible pregnant women receive a single dose of RSV vaccine during the RSV season, which runs from September to January, and other countries have adopted similar recommendations.
A recent study published in JAMA Network Open has provided further insight into the safety of the RSV vaccine, providing valuable real-world data including women with pre-existing health conditions who were not part of the initial clinical trials, thereby expanding the understanding of the vaccine's safety profile.
Vaccine safety
The studies by Moeun Son, associate professor of obstetrics and gynecology at Weill Cornell Medicine, and colleagues analyzed data from 1,026 pregnant women who received the RSV vaccine and compared them with 1,947 unvaccinated pregnant women who received care at two New York City hospitals during the first year the vaccine was available.
The study found that vaccinated women had a similar risk of preterm birth (5.9 percent) compared to unvaccinated women (6.7 percent), with no statistically significant differences between the two groups.
The researchers found no significant differences in several newborn outcomes, including stillbirths, birth weights, NICU admissions, jaundice, hypoglycemia, and sepsis, suggesting that the vaccine had no adverse effects on pregnancy outcomes.
Ms Son said real-world evidence confirms the safety of the vaccine during pregnancy.
“Real-world evidence provides an additional layer of confidence about the safety of this vaccine during pregnancy,” Ms. Son said.
“Randomized clinical trials do not always emulate the populations we see in the clinical setting, but we now have data from multiple populations showing no increase in risk of preterm birth.
“Patients and physicians can be assured that vaccination during pregnancy is a safe way to protect babies from harmful RSV infections,” she said.
How to tame RSV
RSV is a leading cause of infant death worldwide, particularly in low- and middle-income countries.
Recently, the US FDA approved the first RSV vaccine, which has been shown to be 94 percent effective in preventing severe RSV-related lower respiratory illness in people over 60 years of age, adding that maternal RSV vaccines and prophylactic treatments are being developed to protect young children, who are most at risk of serious complications.
Additionally, a maternal RSV vaccine in Phase III trials has demonstrated more than 80 percent efficacy against severe RSV-associated lower respiratory tract infections requiring medical attention during the first three months of life.
Ensuring accessibility to these interventions in low- and middle-income countries is crucial to reducing the global burden of RSV.
As new tools for RSV prevention become available, understanding their duration of protection and appropriate intervention strategies will be essential to maximizing their impact, the report said.
