The Food and Drug Administration (FDA) has granted approval for a groundbreaking solution to combat respiratory syncytial virus (R.S.V.) in infants and vulnerable toddlers. This approval marks one of the first successful measures to protect children from a virus that fills hospitals every year.
Developed by Sanofi and AstraZeneca, the newly approved treatment, known as Beyfortus, utilizes a monoclonal antibody shot. It is expected to be available at the beginning of the fall R.S.V. season. Additionally, Pfizer has submitted an R.S.V. vaccine for pregnant women, aiming to offer protection to infants from the virus.
R.S.V. poses a significant threat to older adults and young infants, often leading to severe illness. In fact, the Centers for Disease Control and Prevention reports that approximately 80,000 children aged 5 and under are hospitalized due to R.S.V. each year.
Dr. John Farley, an official at the FDA Center for Drug Evaluation and Research, emphasized the importance of this approval: “R.S.V. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year. Today’s approval addresses the great need for products to help reduce the impact of R.S.V. disease on children, families, and the healthcare system.”
The positive impact of curbing R.S.V. extends to older adults as well. The FDA has recently granted approval for two vaccines targeting adults aged 60 and older. The virus is responsible for around 60,000 hospitalizations and up to 10,000 deaths annually among individuals aged 65 and older, according to the CDC. By taking either the GSK or Pfizer vaccine, it is estimated that over 21,000 and nearly 25,000 individuals, respectively, in this age group could prevent one R.S.V.-related death in a year.
The antibody shot’s approval for infants was met with unanimous support from FDA advisors, who expressed confidence in the treatment’s efficacy. In clinical studies submitted by Sanofi and AstraZeneca, over 3,200 infants were administered the shot. In a six-month study, the shot demonstrated 79 percent efficacy against severe R.S.V. cases that required medical attention.
Regarding the R.S.V. vaccine aimed at pregnant women by Pfizer, FDA advisors exercised more caution. In May, a panel voted 10 to 4 in favor of its safety, considering concerns about slightly elevated rates of preterm births among mothers who received the vaccine compared to those who received a placebo.
Similarly, studies involving a similar vaccine developed by GSK were halted due to an observed increase in preterm births. The FDA is yet to reach a decision on Pfizer’s maternal vaccine, Abrysvo, but approval is anticipated in the coming weeks, according to a company spokeswoman.
Overall, these recent approvals for R.S.V. treatments and vaccines represent significant progress in safeguarding both infants and older adults against this widespread virus. With ongoing advancements in medical research, there is hope for a healthier future for vulnerable populations.
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