F.D.A. Approves R.S.V. Shot for Infants
The respiratory virus is a global killer of babies and young children. It is the leading cause of death in children under the age of five.
The Food and Drug Administration approved on Monday a vaccine to protect infants and toddlers vulnerable against respiratory syncytial viruses, or R.S.V. This is one of the first protective measures for an illness which fills up children's hospital every year.
The F.D.A. The F.D.A. Pfizer is also considering approval of an R.S.V. vaccine for pregnant women.
Beyfortus, the treatment that was approved by Sanofi AstraZeneca on Monday, treats an illness which can be serious in infants and older adults. According to the Centers for Disease Control and Prevention, about 80,000 children aged 5 and under are hospitalized each year with this virus.
R.S.V. Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research said: The approval today addresses the great need for products to help reduce the impact of R.S.V.
This could be extended to older adults: In recent months, the F.D.A. The F.D.A. Two vaccines have been approved for adults aged 60 and over. According to the C.D.C., the virus causes 60,000 hospitalizations each year and can cause up to 10,000 deaths in older adults. According to the C.D.C., more than 21,000 adults in this age group would have to receive the GSK shot to prevent a single R.S.V. The GSK vaccine was estimated to prevent one R.S.V. death per year. This number was almost 25,000 with the Pfizer shot.
Agents consider the anti-antibody shot for infants
cast a unanimous vote
In June, the FDA approved this treatment for infants. In studies submitted by Sanofi, AstraZeneca and the F.D.A., more than 3,200 babies received the vaccine.
A six-month study has found
79 percent of the R.S.V. The 79 percent of patients who required medical attention.
F.D.A.
More cautious
R.S.V. Pfizer is offering a R.S.V. shot for pregnant women. A panel voted in May that the vaccine is safe. This was due to concerns over slightly higher rates of preterm deliveries among mothers who had received the vaccine compared to those who were given a placebo.
Researchers halted the studies of a similar GSK vaccine after they detected a rise in preterm deliveries. The agency is yet to decide on the maternal Pfizer Abrysvo vaccine. However, a spokeswoman for the company said that they expect approval in the next few weeks.