RSV Shot Is Approved for Infants

The Food and Drug Administration on Monday approved a vaccine to protect infants and vulnerable young children from respiratory syncytial virus (RSV), providing one of the first preventive measures against the disease that fills children’s hospitals each year. is what happened.

A monoclonal antibody vaccine is expected to be available early in the fall RSV season. The FDA is also considering approval of Pfizer’s RSV vaccine for pregnant women to protect infants from the virus.

The treatment, which developers Sanofi and AstraZeneca approved on Monday, is called “Bayfortus,” and it addresses a disease that can be fatal in the elderly and young children. About 80,000 children under the age of five are hospitalized each year with the virus, according to the Centers for Disease Control and Prevention.

“RSV can cause serious illness in infants and some children, resulting in a large number of emergency department and physician visits each year,” said John Dr. Dr Farley said. “Today’s approval addresses a significant need for products to reduce the impact of RSV infection on children, families and the healthcare system.”

The potential to blunt the effects of RSV may also extend to older people: In recent months, the FDA has approved two vaccines against the virus for adults over the age of 60. According to the CDC, the virus is associated with 60,000 hospitalizations and up to 10,000 deaths annually in people over the age of 65. It is estimated that more than 21,000 people in the age group will need the GSK vaccine in a year; for Pfizer’s vaccine, the number was about 25,000.

Advisors to a government agency considering antibody injections for infants voted unanimously in June to approve the treatment for infants.A study submitted to the FDA by Sanofi and AstraZeneca vaccinated more than 3,200 infants Six months of research results revealed Efficacy was 79% for very serious RSV requiring medical attention.

FDA advisers were more cautious about Pfizer’s RSV vaccine for pregnant women. In May, the committee voted 10 to 4 that the vaccine is safe, raising concerns that preterm birth rates among vaccinated mothers were slightly elevated compared with placebo-vaccinated mothers. reflected.

Studies of a similar vaccine by GSK were halted after researchers detected an increase in preterm births. A Pfizer spokeswoman said approval is expected in the next few weeks, but the agency has yet to make a decision on its maternal vaccine, Abrysvo.

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