US Approves Vaccine For Pregnant Women To Prevent RSV In Infants

The United States became the first country to approve a vaccine for pregnant women that protects their kids from serious sickness caused by Respiratory Syncytial Virus (RSV).

The Pfizer shot, which had previously been approved for use in older individuals, has now been approved for use as a single injection from 32 to 36 weeks of pregnancy to protect infants from birth to six months, according to a Food and Drug Administration statement.

It is the most recent of a series of drugs recently licensed against the common bacteria, which, according to government estimates, causes tens of thousands of hospitalizations among infants and the elderly in the United States each year.

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 hospitalization,” said Peter Marks, director of the 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 comes after a clinical investigation involving 7,000 pregnant women. Pfizer’s Abrysvo vaccine reduced severe RSV disease by 82 percent in newborns aged 0-3 months and 69 percent in babies aged 0-6 months.

Abrysvo was previously licensed by the FDA for people aged 60 and up, as was Arexvy, another vaccine developed by GSK.

While RSV is most commonly associated with mild, cold-like symptoms in newborns and young children, it can also result in more catastrophic outcomes such as pneumonia and bronchiolitis.

According to the Centers for Disease Control, RSV infection causes 58,000-80,000 hospitalizations in children under the age of five, making it the primary cause of hospitalization among newborns.

Commonly reported side effects by pregnant patients who received Abrysvo included pain at the injection site, headache, muscle pain and nausea.

A dangerous blood pressure disorder, known as pre-eclampsia, occurred in 1.8 percent of pregnant individuals who received Abrysvo compared to 1.4 percent of those on a placebo.

The FDA further noted an imbalance in preterm births between the group who received the vaccine versus the placebo (5.7 percent against 4.7 percent), 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 FDA approval, a product must receive clearance from the 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, regulators approved an antibody treatment called Beyfortus, developed by Sanofi and AstraZeneca, as a preventative treatment that works like a vaccine to protect babies and toddlers.

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