On Monday, the United States became first country to approve for pregnant women a vaccine which prevents severe diseases caused Respiratory Synytial VirusThe virus is transmitted to babies through the mother.
The Pfizer shot was previously approved for older adults. Now, it can be used as a single dose from 32 to 36 weeks during pregnancy. This will protect babies from birth until six months.The following is a statement by the spokespersonFood and Drug Administration.
This is the latest in an array of medications recently approved for the treatment of the common bacteria, which, according to estimates, causes tens thousands of hospitalizations each year amongst infants and seniors in the United States.
Scientists have been aiming for an RSV shot since the 1960s. But the recent spate of shots is the result of a scientific breakthrough made a decade earlier.
“RSV is one of the most common causes of illness among children. Babies are particularly at risk for severe diseases that may lead to hospitalization.” The following are some of the ways to get in touch with each otherPeter Marks, Director of the FDA Center for Biologics Evaluation and Research.
This approval gives healthcare providers and pregnant women an option to protect their infants against this potentially deadly disease.
The approval comes after a Clinical trialPfizer’s Abrysvo vaccine was shown to reduce severe RSV disease in babies aged 0-3 and 0-6 months by 82 per cent.
Abrysvo, a vaccine made by GSK and approved for adults over 60, was also available from the FDA.
RSV is most commonly associated with mild symptoms, like a cold, but it can lead to more severe outcomes, including pneumonia. pneumoniaBronchitis is a common condition.
RSV causes hospitalizations in children under five, with an estimated 58,000 to 80,000 hospitalized.
Abrysvo can cause side effects such as headaches, nausea, muscle pain, and pain at the injection site.
Abrysvo was found to cause pre-eclampsia in 1.8 % of pregnant women compared with 1.4 % of those taking a The following are examples of how to use the phrase “you can use it”.
The FDA also noted an imbalance between preterm births in the group that received the vaccine and the placebo (5,7 percent against 4,7 percent) but stated the sample size was too small and the subject merited more study.
Pfizer was therefore ordered to continue their research on the risk of preterm pregnancy and preeclampsia.
After FDA approval, a drug must be cleared by the CDC, which will make recommendations about how to best use it. It is not yet clear if it will be ready in time for RSV Season this fall and winter.
However, parents can also look at other medicines.
In the last few days, regulators have approved an Beyfortus treatment, developed by Sanofi AstraZeneca. It is a preventative treatment, which works like a virus to protect babies.
