New RSV Vaccine Approved for Children
2023-07-20
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1U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV.
2RSV sends tens of thousands of American children to the hospital each year.
3The virus is a cold-like disease for most healthy people.
4But 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.
5The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV.
6The 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.
7The drugmaker AstraZeneca developed the drug.
8It will be sold under the name Beyfortus.
9It is a laboratory-made version of an antibody that helps the immune system fight off RSV.
10Under 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.
11Children up to age 2 can receive another dose to protect them during their second season facing the virus.
12Beyfortus is already approved in Canada, Europe and Britain.
13It did not immediately announce the U.S. price of the treatment.
14FDA officials approved the drug based on three studies.
15They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent among infants and children 2 and younger.
16Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.
17A similar antibody drug won FDA approval more than 20 years ago.
18But the drug is only recommended for high-risk babies and requires monthly injections.
19Doctors say that drug is underused.
20But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.
21In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die.
22After years of setbacks for RSV research, drugmakers have made big improvements this year.
23In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer.
24In August, the FDA is expected to make a decision on approving Pfizer's vaccine for pregnant women.
25The aim is for the vaccine to pass along protection to their newborns.
26I'm Dan Novak.
1U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV. 2RSV 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. 3The Food and Drug Administration (FDA) approved the injection for infants and children up to 2 years old who face increased risk of severe RSV. 4The 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. 5The 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. 6Under 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. 7Beyfortus is already approved in Canada, Europe and Britain. It did not immediately announce the U.S. price of the treatment. 8FDA 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. 9Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug. 10A 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. 11In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year. Several hundred die. 12After 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. 13In 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. 14I'm Dan Novak. 15Dan Novak adapted this story for VOA Learning English based on reporting from The Associated Press. 16_______________________________________ 17Words in This Story 18infant - n. a very young child 19antibody - n. a substance produced by the body to fight disease 20dose - n. the amount of a medicine, drug, or vitamin that is taken at one time