2023-08-22 06:22:00
For the first time they approved a vaccine for pregnant women that prevents bronchiolitis in their babiesreported the US Food and Drug Administration (FDA).
This is the pharmaceutical vaccine Pfizer that was approved for use between 32 and 36 weeks of gestation to protect infants from respiratory syncytial virus (RSV).
As reported by the agency AFP, this is a single injection into a muscle. In this way, babies will be protected during the first six months of life.
Bronchiolitis: what it is, how it is transmitted and what to take into account to prevent it
This same vaccine has been authorized since May in the United States for people over 60 years of age. Likewise, it was also approved in July by the European Medicines Agency (EMA), both for babies and for the elderlybut the European Commission must now decide whether to approve its commercialization in the European Union, reported the agency telam.
“This virus is a common cause of illness in children, and infants are among those most at risk of severe illness, which can lead to hospitalization,” said Peter Marks, director of the Center for Evaluation and Research. FDA Biological.
How was the clinical trial of the vaccine once morest bronchiolitis for pregnant women?
The clinical trial, in which some 7,000 pregnant women participated, showed that the vaccine, called Abrysvo, reduced the severe variant of the disease by 82% in babies from 0 to 3 months and by 69% from 0 to 6 months.
RSV usually causes mild cold-like symptoms in infants and young children, but also pneumonia and bronchiolitis.
An estimated 58,000 to 80,000 children under the age of five are hospitalized for RSV infection, according to the Centers for Disease Control and Prevention (CDC), making it the leading cause of hospitalization among infants.
The United States approved the vaccine once morest the bronchiolitis virus that was tested in volunteers from Argentina
The side effects of the vaccine
Between the side effects more frequent in the vaccinated pregnant women with Abrysvo listed discomfort at the injection site, headache or muscle pain and nausea.
By your side, a dangerous blood pressure disorder, known as preeclampsia, occurred in 1.8% of casescompared to 1.4% of those who received a placebo.
The FDA also noted an imbalance in preterm births between the vaccine and placebo groups (5.7% vs. 4.7%).
As a consequence, the agency asked Pfizer to continue studying the risk of preterm birth and preeclampsia.
Upon approval, the product must receive clearance from the CDC, so it’s unclear if it will be available in time for the RSV season this fall and winter.
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