FDA to review R.V. vaccine for infants

V. is a worldwide killer of infants.

Although it can be encountered as a common cold, it can be particularly severe in young infants and older adults. The Centers for Disease Control and Prevention estimate that up to 80,000 children under 5 are hospitalized and up to 300 die each year from the virus. In this winter s tripledemic, V. played a role in filling children's hospitals, which also included the flu and Covid - 19.

As many as 160,000 hospitalizations are attributed to R.S., for adults 65 and older. V. and about 10,000 deaths. The use of vaccines for older adults has also been approved.

The shooting's safety will be closely monitored.

More than 4,200 infants were given the antibody shot during studies provided by the U.S. Food and Drug Administration. A. by drugmakers, including one that found that efficacy against very severe R.S. has been established after six months. v. that required medical attention was 79 percent.

A separate agency panel has recommended that a maternal R.S. be approved. V. The vaccine also under review. Some of the advisers raised concerns about data for that vaccine, and for another like it that suggested a small increase in preterm births.

If the antibody therapy is approved, the FDA will approve it. A.S. said it will continue to monitor the treatment for safety using several data sources. AstraZeneca said it will also conduct periodic safety checks using worldwide data.

C. will review shots for mothers and babies.

If the agency approves the new shot, it's likely to be available in the fall - around the same time that the Pfizer R.S. will be available. V.V. vaccine given during pregnancy called Abrysvo goes on the market.

C. will advise health care providers on the use of the new treatments later this month. Families and doctors could then choose a course of treatment that would take into account the timing of a birth and the R.S. winter. among other factors, V. season, among other factors.

A. said there was no study of the risks or benefits of women taking the maternal R.S. V. and giving the antibody shots to their infants.