US Approves First Vaccine for Pregnant Women to Protect Babies from RSV

The United States (US) Food and Drug Administration (FDA) has given the green light to the first vaccine for pregnant women that can prevent severe respiratory illness caused by Respiratory Syncytial Virus (RSV) in their babies.

The vaccine, developed by Pfizer, is a single injection that can be given from 32 through 36 weeks of pregnancy, and can protect infants from birth through six months.

RSV is a common virus that causes mild cold-like symptoms in most children, but can also lead to serious complications such as pneumonia and bronchiolitis.

According to the Centres for Disease Control (CDC), RSV is the leading cause of hospitalization among infants in the US, with an estimated 58,000-80,000 children younger than five years admitted every year.

The approval of the Pfizer vaccine, called Abrysvo, is a major breakthrough in the fight against RSV, which has been a target of vaccine research since the 1960s.

The vaccine works by stimulating the mother’s immune system to produce antibodies that are transferred to the baby through the placenta and breast milk.

The FDA based its decision on a clinical trial involving some 7,000 pregnant women. The results showed that Abrysvo reduced severe RSV disease by 82 percent in babies from 0-3 months, and by 69 percent from 0-6 months.

Abrysvo was previously approved by the FDA for adults aged 60 and over, as was another RSV vaccine by drugmaker GSK, called Arexvy.

The FDA said that the most common side effects reported by pregnant women who received Abrysvo were pain at the injection site, headache, muscle pain and nausea. It also noted a slightly higher incidence of pre-eclampsia, a dangerous blood pressure disorder, and preterm births among the vaccinated group compared to the placebo group. However, it said that these findings were not conclusive and required further investigation.

The FDA also said that it would require Pfizer to continue studying the safety and effectiveness of Abrysvo in pregnant women and their babies.

The approval of Abrysvo does not mean that it will be available immediately for pregnant women in the US. The CDC will have to issue its recommendations on how to use the vaccine, which may not happen in time for this year’s RSV season, which typically runs from fall to spring.

Meanwhile, parents of infants and toddlers can look for another option to prevent RSV infection. Earlier this month, the FDA approved an antibody treatment called Beyfortus, developed by Sanofi and AstraZeneca, which can be given as a monthly injection to high-risk children under two years old.

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