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[00:00.41] U.S. officials on Monday approved the first long-acting drug to protect babies and young children against respiratory syncytial virus, or RSV.

[00:15.81] RSV sends tens of thousands of American children to the hospital each year.

[00:24.05] The virus is a cold-like disease for most healthy people.

[00:29.63] But it can be life-threatening in the very young and very old.

[00:34.94] Last year, a large increase in RSV cases crowded U.S. hospitals with sick children.

[00:43.71] 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.

[00:59.37] 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.

[01:16.64] The drugmaker AstraZeneca developed the drug.

[01:20.89] It will be sold under the name Beyfortus.

[01:24.35] It is a laboratory-made version of an antibody that helps the immune system fight off RSV.

[01:33.91] 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.

[01:50.64] Children up to age 2 can receive another dose to protect them during their second season facing the virus.

[01:59.94] Beyfortus is already approved in Canada, Europe and Britain.

[02:06.59] It did not immediately announce the U.S. price of the treatment.

[02:12.43] FDA officials approved the drug based on three studies.

[02:17.74] They showed Beyfortus reduced the risk of RSV infection between 70 percent and 75 percent among infants and children 2 and younger.

[02:32.08] Advisers to the Centers for Disease Control and Prevention will meet early next month to recommend exactly who should get the drug.

[02:45.36] 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.

[03:03.69] But they expect the longer-lasting effect of AstraZeneca's shot to be more popular.

[03:11.13] In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year.

[03:20.43] Several hundred die.

[03:23.08] After years of setbacks for RSV research, drugmakers have made big improvements this year.

[03:31.31] In May, the FDA approved two RSV vaccines for older adults from GlaxoSmithKline and Pfizer.

[03:41.94] In August, the FDA is expected to make a decision on approving Pfizer’s vaccine for pregnant women.

[03:50.97] The aim is for the vaccine to pass along protection to their newborns.