Pharmaceutical giant Pfizer’s vaccine has been approved for use between 32 and 36 weeks of pregnancy to protect infants from respiratory syncytial virus (RSV), the US Food and Drug Administration (FDA) reported.
This is a single injection into the muscle.
The FDA explained that the baby will be protected for the first six months of life.
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.
Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said the virus “is a common cause of illness in children, and infants are among the most vulnerable to severe illness that can lead to hospitalization.”
The clinical trial of about 7,000 pregnant women showed that the vaccine, called Abrysvo, reduced severe variant disease by 82% in babies 0 to 3 months old and by 69% in babies 0 to 6 months old.
RSV usually causes mild cold-like symptoms in infants and young children, and can also cause pneumonia and bronchiolitis.
According to the US 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 leading cause of hospitalization in infants.
The most common side effects in pregnant women who received the Abrysvo vaccine included discomfort at the injection site, headache or muscle pain, and nausea.
The dangerous blood pressure disorder known as preeclampsia occurred in 1.8 percent of cases, compared with 1.4 percent of those taking a placebo.
The FDA also noted an imbalance in preterm birth rates between the vaccine and placebo groups (5.7% versus 4.7%).
So the agency asked Pfizer to continue researching the risks of preterm birth and preeclampsia.
Once approved, the product must be licensed by the CDC, so it’s unclear whether it will be available in time for this fall and winter RSV season.
But parents can turn to Beyfortus, another antibody drug approved this month.