FDA advisers endorse antibody to protect against RSV in infants and some young toddlers

DEPENDENT EXPERTS FOR THE FDA WILL MEET TOMORROW TO REVIEW NEW DATA ABOUT AN RSV VACCINE THAT COULD PROTECT NEWBORNS FROM SEVERE INFECTIONS. HERE TO EXPLAIN, DR. DANIEL CHRISTIE’S CHIEF OF INFECTIOUS DISEASES AT THE BRIGHAM DR. CRICKETS, GREAT TO SEE YOU. GOOD TO SEE YOU, ERIC AND BEN. ALL RIGHT, DR. CHRIS, AS YOU WELL KNOW, FEDERAL REGULATORS RECENTLY APPROVED THE WORLD’S FIRST RSV VACCINE, BUT IT’S FOR OLDER ADULTS. WE’VE TALKED WITH YOU ABOUT THIS. WHY DO YOU THINK IT’S IMPORTANT TO HAVE ONE FOR YOUNGER CHILDREN, ESPECIALLY INFANTS? YOU KNOW, RSV CAUSES REALLY SERIOUS INFECTION IN INFANTS. IT’S SURPRISINGLY UP TO 2% OF INFANTS ARE HOSPITALIZED EACH YEAR BECAUSE OF RSV OR SEVERE RSV INFECTION. AND SO HAVING A VACCINE THAT CAN PROTECT THEM AGAINST THEM, THAT IS VERY IMPORTANT. SO LET’S TALK ABOUT THIS NEW DATA. WHAT DOES IT TELL YOU ABOUT THE VACCINE’S EFFECTIVENESS? YES. SO THE VACCINE IS ABOUT 80% EFFECTIVE UP TO THREE MONTHS IN PREVENTING SEVERE RSV INFECTION IN INFANTS AND ABOUT 70% EFFECTIVE OUT TO ABOUT SIX MONTHS. AND SO THAT’S REALLY IMPORTANT BECAUSE THAT’S THE CRUCIAL PERIOD FOR PROTECTING INFANTS AGAINST RSV INFECTION. SO THE FDA ANNOUNCED IT DOES HAVE SOME SAFETY CONCERNS, THOUGH, ABOUT THE NEW VACCINE. DO YOU THINK THEY’RE SIGNIFICANT ENOUGH FOR THE AVERAGE PERSON TO BE CONCERNED ABOUT WHAT THE FDA SAID IN THERE? ANALYSIS OF THE DATA IS THAT THERE WAS A A NUMERICAL IMBALANCE, MEANING THERE WERE SLIGHTLY MORE WOMEN WHO RECEIVED THE VACCINE WHO HAD EARLY BIRTH COMPARED TO THOSE WHO DID NOT GET THE VACCINE. BUT THAT WAS NOT STATISTICALLY SIGNIFICANT. BUT THEY HIGHLIGHTED THAT AND ASKED THE ADVISORY COMMITTEE TOMORROW TO PAY SOME ATTENTION TO THOSE DATA AND TO DISCUSS THE SIGNIFICANCE OF THAT, WHETHER IT’S REALLY AN IMPORTANT ISSUE OR NOT. BUT JUST BECAUSE THERE WERE SLIGHTLY MORE DOESN’T MEAN THAT IT WAS REALLY CAUSED BY THE VACCINE. OKAY. DR. DANIEL CRITICAS, AS AL

Advisers to the U.S. Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV.Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus.Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment.The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable.If approved, it will be the first single-dose preventative treatment for all infants against RSV. Unlike with a vaccine, with which the body builds up its immunity in reaction over time, a monoclonal antibody works right away.In trials, nirsevimab reduced the risk of RSV-linked lower respiratory tract infections that needed medical attention by about 75% and RSV-related hospitalization by about 78% when compared with a placebo. No major safety concerns were identified; some common side effects were rash and injection-site reactions.Video below: Doctor discusses protecting babies from RSVAnother monoclonal antibody treatment approved in the U.S. and Europe, palivizumab, or Synagis, protects against infection in high-risk infants. With that treatment, infants get an intramuscular injection every month during RSV season, and it usually requires five doses.Last month, the FDA’s vaccine advisers voted in support of a new vaccine to prevent RSV in infants. That maternal vaccine is a single-dose shot that would be given to a pregnant people late in pregnancy, triggering the development of antibodies that are passed on to the fetus and providing protection for about the first six months of a baby’s life. Trials show that the vaccine, made by Pfizer, cuts the risk that infants would need to see a doctor or be admitted to the hospital with a moderate to severe infection.Nearly every child gets RSV before the age of 2, according to the U.S. Centers for Disease Control and Prevention, but last winter, the virus overwhelmed pediatric hospitals all across the United States. Although it’s often a milder respiratory infection for children and most adults, studies show that it is still a leading cause of hospitalization among infants.Globally, in 2019 alone, there were 33 million cases and more than 3.6 million hospitalizations. It’s estimated that there were 26,300 in-hospital RSV deaths of children younger than 5 and 101,400 deaths overall, according to a 2022 study published in the Lancet.

Advisers to the U.S. Food and Drug Administration voted Thursday to endorse a monoclonal antibody designed to protect infants and some young toddlers from RSV.

Members of the agency’s Antimicrobial Drugs Advisory Committee voted 21-0 that the benefit-risk profile of nirsevimab was favorable in infants and 19-2 that it was favorable in children up to 24 months who are vulnerable to severe respiratory syncytial virus.

Next, the FDA will consider the advice of the advisers and decide whether to approve the treatment.

The monoclonal antibody, nirsevimab, was developed by AstraZeneca and Sanofi. It’s designed to be given to infants in a single shot at birth or just before the start of a baby’s first RSV season, or as a larger dose in a second RSV season in children who are highly vulnerable.

If approved, it will be the first single-dose preventative treatment for all infants against RSV. Unlike with a vaccine, with which the body builds up its immunity in reaction over time, a monoclonal antibody works right away.

In trials, nirsevimab reduced the risk of RSV-linked lower respiratory tract infections that needed medical attention by about 75% and RSV-related hospitalization by about 78% when compared with a placebo. No major safety concerns were identified; some common side effects were rash and injection-site reactions.

Video below: Doctor discusses protecting babies from RSV

Another monoclonal antibody treatment approved in the U.S. and Europe, palivizumab, or Synagis, protects against infection in high-risk infants. With that treatment, infants get an intramuscular injection every month during RSV season, and it usually requires five doses.

Last month, the FDA’s vaccine advisers voted in support of a new vaccine to prevent RSV in infants. That maternal vaccine is a single-dose shot that would be given to a pregnant people late in pregnancy, triggering the development of antibodies that are passed on to the fetus and providing protection for about the first six months of a baby’s life. Trials show that the vaccine, made by Pfizer, cuts the risk that infants would need to see a doctor or be admitted to the hospital with a moderate to severe infection.

Nearly every child gets RSV before the age of 2, according to the U.S. Centers for Disease Control and Prevention, but last winter, the virus overwhelmed pediatric hospitals all across the United States. Although it’s often a milder respiratory infection for children and most adults, studies show that it is still a leading cause of hospitalization among infants.

Globally, in 2019 alone, there were 33 million cases and more than 3.6 million hospitalizations. It’s estimated that there were 26,300 in-hospital RSV deaths of children younger than 5 and 101,400 deaths overall, according to a 2022 study published in the Lancet.

FDA advisers endorse antibody to protect against RSV in infants and some young toddlers

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