August 22, 2023 – The long-awaited RSV vaccine, which could be given to pregnant women, was approved by the FDA on Monday.
The vaccine known as Abrysvo and could be given between 32 and 36 weeks of pregnancy. It protects infants from birth to six months of age against the respiratory virus. Most children are infected with the highly contagious virus a minimum of once by the age of two. Very young children are at particular risk of significant complications akin to pneumonia or bronchitis. Studies have shown that the brand new vaccine reduced this risk by as much as 82%.
Before the vaccine was available, in response to the CDC. Treatments, the CDC says, may include “oxygen, intravenous fluids (if patients are not eating or drinking), and mechanical ventilation (a machine that helps with breathing). Most people improve with this type of supportive care and are discharged after a few days.”
RSV normally causes cold-like symptoms, however the virus carries the danger of significant complications that may result in death in young children and the elderly. The CDC Estimates Each yr, 100 to 300 deaths in children under five years of age and 6,000 to 10,000 deaths in people aged 65 and over are attributed to RSV.
Earlier this yr, the FDA approved Pfizer's Abrysvo vaccine to be used in older adults. This can be the primary yr that an antibody shot has been available that could be given after birth to stop severe RSV disease in infants under one yr of age.
“We are incredibly grateful to clinical trial participants and study research teams around the world, as well as our Pfizer colleagues, for their commitment to making this vaccine available,” said Dr. Annaliesa Anderson, Pfizer’s Chief Scientific Officer, in a opinion“Today, a long-sought goal has been achieved: to provide a vaccine for mothers that will help protect infants aged six months and younger – when they are most at risk of potentially serious consequences from RSV infection.”
In his agreement NoticeThe FDA found that 1.8% of pregnant women who received Abrysvo experienced a dangerous hypertension condition called preeclampsia, which might occur while pregnant, compared with 1.4% of those that received a placebo. The FDA also reported that low birth weight and jaundice in infants were more common among the many pregnant women who received Abrysvo compared with the placebo group.
Studies also showed that pregnant women who received the vaccine had a 5.7% rate of preterm birth, compared with a 4.7% rate for girls who received a placebo. The FDA called the difference a “numerical imbalance” but said within the approval notice that no “causal relationship” may very well be established, noting that girls who were already at high risk for preterm birth were excluded from clinical trials. Pfizer must conduct ongoing studies to watch the danger of preeclampsia in addition to preterm birth, the FDA said.