The new RSV vaccine can be taken by mothers-to-be during their eighth month of pregnancy. — Positive Parenting
The United States recently became the first country to approve a vaccine for pregnant women that prevents severe disease caused by respiratory syncytial virus (RSV) in their babies.
They were quickly followed by the European Union three days later, which also approved the drug for use in older adults.
The shot, which was already approved for use in older adults in the US, has now been greenlighted for use as a single injection from 32 through 36 weeks of pregnancy, to protect infants from birth through to six months, a statement by the US Food and Drug Administration (FDA) said on Aug 21 (2023).
It is the latest in a succession of medicines recently approved against the common microbe, which can cause serious illness in infants and the elderly.
Researchers have targeted an RSV vaccine since the 1960s, but the spate of shots that are emerging now were made possible thanks to a scientific breakthrough a decade ago.
“RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalisation,” said Dr Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research.
“This approval provides an option for healthcare providers and pregnant individuals to protect infants from this potentially life-threatening disease.”
The approval follows a clinical trial involving some 7,000 pregnant women, which showed that the RSV vaccine reduced severe disease caused by the virus by 82% in babies during the first three months of life, and by 69% during the first six months of life.
The vaccine produced by US multinational pharmaceutical and biotechnology corporation Pfizer, was previously approved by the US FDA for adults aged 60 and over, as was another RSV vaccine by British multinational pharmaceutical and biotechnology corporation GSK.
The latter was approved for similar use in the EU in June (2023).
While RSV most often causes mild, cold-like symptoms in infants and young children, it can also lead to more serious outcomes such as pneumonia and bronchiolitis.
An estimated 58,000-80,000 children younger than five years are hospitalised yearly in the US due to RSV infection, according to the US Centers for Disease Control and Prevention (CDC), making it the leading cause of hospitalisation among infants.
In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children younger than five years of age, while the virus is estimated to cause about 20,000 deaths in older adults each year.
Commonly-reported side effects by pregnant patients who received Pfizer’s RSV vaccine included pain at the injection site, headache, muscle pain and nausea.
A dangerous blood pressure disorder, known as pre-eclampsia, occurred in 1.8% of pregnant individuals who received the vaccine, compared to 1.4% of those on a placebo.
The US FDA further noted an imbalance in preterm births between the group who received the vaccine versus the placebo (5.7% against 4.7%), but said the sample size was small and the topic merited further study.
It has therefore required Pfizer to continue studying the risk of preterm birth and pre-eclampsia.
Following US FDA approval, a product must receive clearance from the US CDC, which will offer recommendations on how best to use it, meaning it’s not clear whether it will be available in time for RSV season this fall and winter.
Parents can look to another medicine, however.
Earlier this month (August 2023), US regulators approved an antibody treatment called nirsevimab as a preventative treatment that works like a vaccine to protect babies and toddlers.
The EU had already approved this treatment, jointly developed by French multinational pharmaceutical and healthcare company Sanofi and British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca, for use in infants last year (2022). – AFP Relaxnews and Reuters
