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The Food and Drug Administration (FDA) approved this Monday the first vaccine aimed at preventing infections in babies, with the new drug designed to be administered to pregnant mothers in their third trimester so that their newborn babies can have protection from the moment they are born.
According to The Hill’s review, the single-dose injections called Abrysvo are made by Pfizer and have been approved for use between 32 and 36 weeks of pregnancy. The FDA’s Advisory Committee on Vaccines and Related Biologicals voted to recommend the drug in May.
“RSV is a common cause of illness in children, and infants are among those most at risk of severe illness, which can lead to hospitalization,” Peter Marks, director of the Center for RSV, said in a statement. FDA Biological Evaluation and Investigation.
“This approval provides an option for health care providers and pregnant individuals to protect babies from this life-threatening disease,” Marks said.
When the advisory committee reviewed Abrysvo in May, Pfizer presented data finding that neutralizing antibodies to RSV were highest in infants whose mothers received the vaccine up to 6 months of age. Babies younger than 6 months are at particularly high risk of developing severe cases of RSV.
For its part, the FDA noted in its announcement Monday that, in a clinical study, Abrysvo reduced the risk of lower respiratory tract disease by 82% in the first 90 days after birth and by 70% in the first few weeks. 180 days.
“We are incredibly grateful to clinical trial participants and study investigator teams around the world, as well as our colleagues at Pfizer, for their commitment to making this vaccine available,” said Pfizer senior vice president, Annaliesa Anderson, in a statement.
As he pointed out, with this antidote a long-sought goal of delivering a maternal vaccine that will help protect babies six months of age and younger has been achieved, when they are most at risk of possible serious consequences of RSV.”
Babies in intensive care due to RSV
Large numbers of infants and young children were hospitalized last winter due to RSV, with many hospitals reaching capacity and some running out of ventilators as facilities also sought to care for COVID-19 and flu patients.
The article in The Hill notes that most children will be exposed to RSV, known as a common “daycare illness,” before the age of 2. COVID-19 quarantines are thought to possibly have limited exposure, contributing to a tougher RSV season, though doctors have noted that higher than normal case rates occurred even before the pandemic.
Other than a monoclonal antibody given to extremely high-risk cases, until this year there were no effective treatments specifically directed against RSV. This year, the FDA approved two RSV vaccines for older adults, and a preventive monoclonal antibody against the virus was approved last month for infants and young children.
The most common side effects reported were pain at the injection site, headache, muscle pain, and nausea. Preeclampsia also occurred at a slightly higher rate among those who received the vaccine in the studies, and the FDA noted that “birth weight and jaundice in infants” occurred at a higher rate among those who received the vaccine.
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