Towards the prevention of lower respiratory tract infections and serious illnesses in infants, the US Food and Drug Administration On Monday (FDA) approved the respiratory syncytial virus (RSV) vaccine for use in women during the mid-third trimester of pregnancy.
The approval allows the vaccine to be given to women 32 to 36 weeks pregnant to protect babies up to six months of age.
The shot becomes the second RSV vaccine and the third new intervention against the disease this year.
In May, the FDA approved the Abrysvo vaccine to prevent RSV in people 60 years of age and older.
The same vaccine is now approved for pregnant women in their third trimester. And in July, the agency nirsevimab approvedan antibody-based injection that protects babies against RSV immediately after birth.
In a statement posted on its website, the FDA said that Abrysvo is administered as a single-dose injection into the muscle.
The director of the FDA’s Center for Biological Evaluation and Research, Peter Marks, said that RSV is a common cause of illness in children, and that infants are among those most at risk of severe illness, which can lead to hospitalization.
Mr. Marks said this approval provides an option for health care providers and pregnant people to protect babies from this potentially deadly disease.
About RSV
RSV is a highly contagious virus that causes respiratory infections in people of all ages.
It is the most common cause of lower respiratory tract disease in infants worldwide. In most of the US, RSV circulation is seasonal, generally beginning in the fall and peaking in the winter.
The virus is especially common in children, and most people can be expected to become infected with RSV by the time they reach two years of age.
“While RSV most often causes cold-like symptoms in infants and young children, it can also lead to severe LRTD, such as pneumonia and bronchiolitis (inflammation of the small airways in the lungs),” he said.
“In infants and children, the risk of LRTD associated with RSV is highest during the first year of life.”
New interventions have been a long time coming in the treatment of RSV, which in the US sends 58,000 to 80,000 children under the age of five to the hospital each year and kills 100 to 300 annually.
Vaccine
Pfizer, which makes Abrysvo for both older people and now pregnant women, has been developing the injection since the 2010s after scientists at the National Institutes of Health discovered just the right form of RSV to capture in the vaccine and present to the immune system.
in a study reviewed by the FDA involving pregnant women in 18 countries, the vaccine was 81.8 percent effective in preventing severe respiratory illness requiring medical attention in infants in the first 90 days after birth.
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The FDA said the most common side effects in pregnant women were fatigue, headache, pain at the injection site, muscle pain, nausea, joint pain and diarrhea.
“The safety of Abrysvo was evaluated in two studies. In one study, approximately 3,600 pregnant women received a single dose of Abrysvo and approximately 3,600 pregnant women received a placebo,” she said.
“In the second study, approximately 100 pregnant women received Abrysvo and approximately 100 pregnant women received placebo.”
He said that although not commonly reported, a dangerous hypertensive disorder, known as preeclampsia, occurred in 1.8 percent of pregnant women who received Abrysvo compared with 1.4 percent of pregnant women who received a placebo.
He noted that in safety studies, low birth weight and jaundice in babies occurred at a higher rate in pregnant women who received Abrysvo compared to pregnant women who received placebo.
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