RSV vaccine safe for pregnant women- Study

A new study by Real-World has stated that the respiratory syncytial virus (RSV) vaccine is safe when administered to pregnant women.

This was disclosed by Gavi- the Vaccine Alliance, on its website on Wednesday.

The study revealed that thousands of women who received the RSV vaccine to protect their babies assured that the vaccine was safe.

RSV vaccine

According to the report, RSV is a leading cause of lower respiratory tract infections among young children, especially those under six months old are at high risk of severe disease and death.

It stated that in 2019, many underage children in low-income countries were hospitalised due to the vaccine.

“During 2019 alone, it was responsible for some 3.6 million hospital admissions and 101,400 deaths in under-fives, with children in low- and middle-income vaccination disproportionately affected,” it said.

The study shows that maternal vaccination against RSV during pregnancy enables mothers to safeguard their babies against the virus during their most vulnerable early months, while also reducing their own risk of infection.

Maternal RSV vaccine

The study revealed that the RSVpreF (Abrysvo) vaccine has made history as the first to be approved for use during pregnancy, shielding infants from lower respiratory tract disease caused by RSV by transferring protective antibodies through the placenta.

The group said the US Centre for Disease Control and Prevention (CDC) has recommended that eligible pregnant women receive a single dose of the RSV vaccine during the RSV season, which spans from September to January, and other countries have adopted similar recommendations.

A recent study published in JAMA Network Open has offered further insight into the safety of the RSV vaccine, providing valuable real-world data that includes 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.

Safety of vaccine

An Associate Professor of Obstetrics and Gynaecology at Weill Cornell Medicine, Moeun Son, and colleagues’ studies analysed data from 1,026 pregnant women who received the RSV vaccine and compared it to 1,947 unvaccinated pregnant women who received care at two hospitals in New York City during the vaccine’s first year of availability.

The study revealed that vaccinated women had a similar risk of preterm birth (5.9 per cent ) compared to unvaccinated women (6.7 per cent ), with no statistically significant difference between the two groups.

The researchers found no significant differences in various 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’s evidence confirms vaccine safety in pregnancy.

“The real-world evidence provides an additional layer of confidence about the safety of this vaccine during pregnancy,” Ms Son said.

“Randomised clinical trials don’t always emulate the populations we see in the clinical setting, but now we have data from multiple populations showing no increase in preterm birth risk.

“Patients and clinicians can feel confident that vaccination during pregnancy is a safe way to protect infants from harmful RSV infections,” she said.

Taming RSV

RSV is a leading cause of death in infants worldwide, particularly in low- and middle-income countries.

Recently, the US FDA approved the first vaccine against RSV, which has shown to be 94 per cent effective in preventing severe RSV-related lower respiratory disease in individuals over 60, adding that maternal RSV vaccines and prophylactic treatments are being developed to protect young children, who are most at risk of severe complications.

Also, a maternal RSV vaccine in Phase III trials has shown over 80 per cent efficacy against medically attended severe RSV-associated lower respiratory tract infections during the first three months of life.

Ensuring accessibility of these interventions in low- and middle-income countries is crucial to reducing the global RSV burden.

As new tools for RSV prevention become available, understanding their duration of protection and appropriate intervention strategies will be essential to maximise their impact, the report indicated.