Abrysvo, all about the Pfizer vaccine approved by the US FDA for pregnant women against bronchiolitis of newborns
The FDA has approved the first pregnancy vaccine to protect newborns from bronchiolitis . Pfizer's vaccine targets respiratory syncytial virus (RSV) by transferring protective antibodies from mother to baby before birth. The same drug for the over 60s is already on the market
Against bronchiolitis in newborns comes the Pfizer vaccine to be administered during pregnancy.
The US health authorities have authorized for the first time a vaccine intended to protect newborns from bronchiolitis, which will be given to pregnant women for this purpose.
The vaccine, manufactured by pharmaceutical giant Pfizer and marketed under the name Abrysvo, targets respiratory syncytial virus (RSV) , which particularly affects young children. The vaccine is authorized by the Food and Drug Administration (Fda), the US drug authority, for pregnant women between 32 and 36 weeks.
This same vaccine was already approved last May in the United States for people aged 60 and over. It was also approved by the European Medicines Agency in July – for both infants and the elderly – but the European Commission must now decide on its marketing authorization within the European Union.
All the details.
FDA APPROVED
The Food and Drug Administration on Monday approved a vaccine intended for pregnant women to protect babies from RSV, or respiratory syncytial virus. Babies will be protected during the first six months of their life.
HOW DOES IT WORK
The Abrysvo vaccine will be inoculated with a single intramuscular injection. The single-dose injection, made by Pfizer, stimulates the production of protective antibodies that are transferred from mother to baby across the placenta. It is the first vaccine that can protect children against RSV, which causes lower respiratory disease that can be serious in newborns.
A VACCINE AGAINST THE RESPIRATORY SYNCITIAL VIRUS
For decades, public health officials have had little defense against respiratory syncytial virus, which infects nearly all children before the age of two. Newborns are especially vulnerable because they have smaller airways, as are young children with asthma and other conditions that place them at high risk.
“This virus is a common cause of illness in children, and newborns are among the people most at risk of serious illness, which could lead to hospitalization,” said Peter Marks, an FDA official, as reported by the Washington Post .
THE SIDE EFFECTS
In approving the maternal RSV vaccine, the FDA said the most common side effects reported in the studies were injection site pain, headache, muscle aches and nausea.
INDICATIONS FOR ADMINISTRATION
Finally, in May, an FDA advisory panel reviewed the data on the vaccine, and while the panel generally praised its effectiveness, some reservations emerged about the duration of protection and the potential risk of preterm birth. In the study, a slightly higher rate of births before 37 weeks of gestation was found among people who received the vaccine (5.7%) than those who received a placebo (4.7%).
While the difference was not statistically significant, the vaccine prescription label will contain a warning not to give Abrysvo before 32 weeks of gestation due to this numerical imbalance. Both observed rates were lower than the rate of preterm births in the general population: about 10%, according to the CDC, the US Centers for Disease Control and Prevention. Therefore, Pfizer said it will continue to monitor the risk of preterm birth among vaccinated individuals.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/abrysvo-ecco-il-vaccino-pfizer-approvato-dalla-fda-usa-per-donne-incinte-contro-la-bronchiolite-dei-neonati/ on Tue, 22 Aug 2023 09:53:44 +0000.