USA became the first country to ratify the bill on Monday Vaccines for Pregnant Women this prevents Bronchiolitis in their babies.
Vaccines from pharmaceutical giants Pfizer Approved for use at 32nd and 36th weeks of pregnancyThe US Food and Drug Administration (FDA) reports that in order to protect infants from respiratory syncytial virus (RSV) infection.
This is a single injection into the muscle.
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Babies will be protected for the first six months of life, explains US Food and Drug Administration.
The vaccine has been approved in the United States for people over 60 since May.
The European Medicines Agency (EMA) also approved the drug for use in infants and the elderly in July, but the European Commission must now decide whether to approve it for marketing in the EU.
The virus “was a common cause of illness in children, and infants were among the most vulnerable to severe illness, which could lead to hospitalization,” recalls the center’s director, Peter Marks. FDA Center for Biological Research and Evaluation.
The clinical trial involving about 7,000 pregnant women showed that the vaccine, called Abriswarreducing severe variant disease in infants 0 to 3 months by 82% and by 69% in infants 0 to 6 months.
he RSV It usually causes mild cold-like symptoms in infants and young children and can also cause pneumonia and bronchiolitis.
According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 58,000 to 80,000 children under the age of 5 are hospitalized with RSV infection, making it the is the leading cause of hospitalization in infants.
one of the most common side effects Pregnant women vaccinated against Abrysvo These include discomfort at the injection site, headache or muscle pain, and nausea.
dangerous disease blood pressure, as. .and be known preeclampsiawhich occurred in 1.8% of cases compared with 1.4% of those receiving placebo.
The FDA also noted an imbalance in preterm birth rates between the vaccine and placebo groups (5.7% versus 4.7%).
Therefore, the agency asked Pfizer to continue studying the risk Preterm birth and preeclampsia.
After approval, the product must be approved by the state CDC, So it’s unclear if it will launch in time for this fall and winter’s VRS season.
But parents can switch to another drug approved this month An antibody called Beyfortus.