New RSV Vaccine Approved for Children

2023-07-20

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1
  • U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV.
  • 2
  • RSV sends tens of thousands of American children to the hospital each year.
  • 3
  • The virus is a cold-like disease for most healthy people.
  • 4
  • But it can be life-threatening in the very young and very old. Last year, a large increase in RSV cases crowded U.S. hospitals with sick children.
  • 5
  • The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.
  • 6
  • The approval helps "reduce the impact of RSV disease on children, families and the health care system" said FDA's Dr. John Farley in a statement.
  • 7
  • The drugmaker AstraZeneca developed the drug.
  • 8
  • It will be sold under the name Beyfortus.
  • 9
  • It is a laboratory-made version of an antibody that helps the immune system fight off RSV.
  • 10
  • Under the FDA approval, babies - including small infants - can receive a single injection to protect against their first season of RSV, which usually lasts about five months.
  • 11
  • Children up to age 2 can receive another dose to protect them during their second season facing the virus.
  • 12
  • Beyfortus is already approved in Canada, Europe and Britain.
  • 13
  • It did not immediately announce the U.S. price of the treatment.
  • 14
  • FDA officials approved the drug based on three studies.
  • 15
  • They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent among infants and children 2 and younger.
  • 16
  • Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.
  • 17
  • A similar antibody drug won FDA approval more than 20 years ago.
  • 18
  • But the drug is only recommended for high-risk babies and requires monthly injections.
  • 19
  • Doctors say that drug is underused.
  • 20
  • But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.
  • 21
  • In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die.
  • 22
  • After years of setbacks for RSV research, drugmakers have made big improvements this year.
  • 23
  • In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer.
  • 24
  • In August, the FDA is expected to make a decision on approving Pfizer's vaccine for pregnant women.
  • 25
  • The aim is for the vaccine to pass along protection to their newborns.
  • 26
  • I'm Dan Novak.
  • 1
  • U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV.
  • 2
  • RSV sends tens of thousands of American children to the hospital each year. The virus is a cold-like disease for most healthy people. But it can be life-threatening in the very young and very old. Last year, a large increase in RSV cases crowded U.S. hospitals with sick children.
  • 3
  • The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.
  • 4
  • The approval helps "reduce the impact of RSV disease on children, families and the health care system" said FDA's Dr. John Farley in a statement.
  • 5
  • The drugmaker AstraZeneca developed the drug. It will be sold under the name Beyfortus. It is a laboratory-made version of an antibody that helps the immune system fight off RSV.
  • 6
  • Under the FDA approval, babies - including small infants - can receive a single injection to protect against their first season of RSV, which usually lasts about five months. Children up to age 2 can receive another dose to protect them during their second season facing the virus.
  • 7
  • Beyfortus is already approved in Canada, Europe and Britain. It did not immediately announce the U.S. price of the treatment.
  • 8
  • FDA officials approved the drug based on three studies. They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent among infants and children 2 and younger.
  • 9
  • Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.
  • 10
  • A similar antibody drug won FDA approval more than 20 years ago. But the drug is only recommended for high-risk babies and requires monthly injections. Doctors say that drug is underused. But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.
  • 11
  • In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die.
  • 12
  • After years of setbacks for RSV research, drugmakers have made big improvements this year. In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer.
  • 13
  • In August, the FDA is expected to make a decision on approving Pfizer's vaccine for pregnant women. The aim is for the vaccine to pass along protection to their newborns.
  • 14
  • I'm Dan Novak.
  • 15
  • Dan Novak adapted this story for VOA Learning English based on reporting from The Associated Press.
  • 16
  • _______________________________________
  • 17
  • Words in This Story
  • 18
  • infant - n. a very young child
  • 19
  • antibody - n. a substance produced by the body to fight disease
  • 20
  • dose - n. the amount of a medicine, drug, or vitamin that is taken at one time