Breakthrough Vaccine: Pregnant Women Can Now Protect Babies from Severe RSV
The United States and the European Union have recently approved a breakthrough vaccine that can protect babies from severe respiratory syncytial virus (RSV) disease. This vaccine can be taken by pregnant women during their eighth month of pregnancy, providing a shield for infants from birth through to six months.
RSV is a common cause of illness in children, with infants being particularly vulnerable to severe disease that may necessitate hospitalization. However, thanks to a scientific breakthrough a decade ago, researchers have been able to develop an effective RSV vaccine. This latest approval by the US FDA and the European Union is based on positive results from a clinical trial that involved 7,000 pregnant women. The trial showed that the vaccine reduced severe RSV disease by 82% in babies during their first three months of life and by 69% during the first six months.
The vaccine, which is produced by Pfizer, has already been approved for use in older adults. Another RSV vaccine by GSK has also been authorized for similar use in older adults in the US. These vaccines offer hope in fighting RSV, a virus that can lead to serious complications such as pneumonia and bronchiolitis.
While RSV typically causes mild symptoms in infants and young children, it can still result in hospitalization. In the US alone, an estimated 58,000 to 80,000 children under the age of five are hospitalized each year due to RSV infection. In the EU, approximately 245,000 yearly hospital admissions are associated with RSV in children under five, and the virus causes about 20,000 deaths in older adults annually.
The RSV vaccine does come with potential side effects. Pregnant patients who received Pfizer’s vaccine reported common side effects such as pain at the injection site, headache, muscle pain, and nausea. There were also cases of a blood pressure disorder called pre-eclampsia occurring in individuals who received the vaccine, although the incidence was slightly higher than in those who received a placebo. Additionally, there was a small discrepancy in preterm births between the vaccine and placebo groups. As a result, further studies are needed to assess the risks associated with preterm birth and pre-eclampsia.
Before the RSV vaccine becomes widely available, it must receive clearance from the US CDC, which will provide recommendations on its usage. Thus, it remains uncertain whether the vaccine will be accessible in time for the upcoming RSV season this fall and winter. However, there is an alternative preventive treatment called nirsevimab, which was recently approved in the US. This treatment, developed by Sanofi and AstraZeneca, works similarly to a vaccine and offers protection to babies and toddlers. It had already been approved for use in infants in the EU last year.
The approval of the RSV vaccine for pregnant women marks a significant milestone in the fight against RSV. By protecting infants from this potentially life-threatening virus, healthcare providers and pregnant individuals now have an additional tool to safeguard the health of newborns. Continued research and development in this field will help ensure the well-being of both children and adults in the face of RSV.
