2023-07-18 09:46:11
Dubai, United Arab Emirates (CNN) — This fall, parents and pediatricians will have a new option to protect children from a virus that attacks the lungs and is the leading cause of hospitalizations for infants under one year of age in the United States each year.
On Monday, the US Food and Drug Administration approved Nirsevimab to protect newborns from respiratory syncytial virus (RSV).
Nercivimab, which will be sold under the brand name “Beyfortus”, is not a vaccine, as vaccines stimulate the body to produce antibodies to pathogens. Instead, nercivimab is considered a form of passive immunity. It’s a ready-made antibody that can bind to the virus, preventing it from infecting healthy cells. The immune system does not have to produce any antibody.
It is given as a single injection to infants before the start of the respiratory syncytial virus (RSV) season, which usually peaks during the fall and winter. The FDA approval also allows for a second injection for infants up to 24 months of age who remain vulnerable during the second RSV season.
“RSV can cause serious illness in infants and some children, causing many emergency department and doctor’s office visits annually,” Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a news release.
“Today’s approval addresses the significant need for medicines to help reduce the impact of RSV disease on children, families and the healthcare system,” he added.
The drug will be evaluated by a group of experts who advise the US Centers for Disease Control and Control (CDC) on its vaccine recommendations. The Advisory Committee on Immunization Practices (ACIP) has released draft recommendations and clinical considerations for the use of nercivimab, but the group is expected to formalize those with voting rights at the next meeting.
After approval by the Centers for Disease Control, nercivimab becomes the second antibody available to protect young children from RSV. The first drug, Palivizumab, or Synagis, was only used to protect the most vulnerable babies: those born prematurely and those younger than 6 months old. It only lasts a short time in the body, so doctors give it once a month, right in the RSV season, until the danger has passed.
The drug is only partially effective, keeping at-risk children out of hospital regarding 50% of the time.
The antibody was stabilized in Neversivimba so that it lasts longer in the body, between four and six months, and appears to be stronger.
It is authorized for use by all infants, even healthy babies born at term.
“This virus can affect all children, not just children with certain health conditions, but even healthy children,” said Dr. Rachel Dawkins, medical director of the pediatric and adolescent medicine clinics at Johns Hopkins Children’s Hospital in St. Petersburg, Florida. . “As a pediatrician, I am very excited regarding the idea of getting vaccinated to prevent serious illnesses caused by RSV,” she added.
And nercivimab may not be the only option to reduce infection this fall, as the US Food and Drug Administration is studying data for the “Pfizer” vaccine for pregnant women that would also protect children. In this case, the mother makes antibodies that cross the placenta to protect the fetus, and its effectiveness is expected to continue through the first few months of the infant’s life.
This vaccine will protect children from the moment they are born, which is useful if the infection appears in the off-season. Vaccines also prompt the mother’s body to make more than one type of antibody that will provide broad-spectrum protection.
“Any strategy we can use to help reduce infant RSV infection would be beneficial,” Dawkins said. And she continued: “So if mothers are able to receive the vaccine in order to protect their newborn children, that is good. Or if children have the ability to obtain this antibody, that is also beneficial, and I think there is some evidence that they work together.”
In the clinical trials leading to approval, nercivimab was approximately 70% effective in reducing the risk of a child needing to see a doctor with RSV infection, and 78% effective in reducing RSV hospitalization compared to placebo, according to the FDA analysis.
This means that nercefimiab will reduce hospitalization for RSV by 1 in 56 infants treated. So although antibodies like these tend to be expensive, doctors say if the drug helps with hospitalizations for children, it’s likely worth the cost.
In studies, the treatment was generally safe and well tolerated. Only a few children, less than 1%, had skin reactions following the injection, which disappeared with treatment.
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