US Food and Drug Administration (FDA) Approved for Abrysvoa vaccine developed by Pfizer, Prevention of Lower Respiratory Diseases in Pregnant Women (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) Infants from birth to 6 months. Abrysvo is approved for use between 32 and 36 weeks of gestation and is administered as a single intramuscular injection.
Although there are antibody treatments for young babies, Abrysvo is the only vaccine available for maternal immunization. “This approval provides healthcare professionals and pregnant women an option to protect infants from this potentially deadly disease,” said Peter Marks, director of the FDA’s Center for Biological Research and Evaluation. In May, U.S. regulators Green light for use of vaccine to prevent virus in people 60 or older. With regard to Europe, the CHMP also recommended use during pregnancy at its last meeting in July.
In an ongoing international randomized placebo-controlled clinical study, To evaluate the safety and efficacy of Abrysvo for immunization in pregnant women. Among the approximately 3,500 pregnant women who received the vaccine, compared with the approximately 3,500 pregnant women who received a placebo, Abrysvo reduces the risk of severe LRTD by 81.8% in the first 90 days of life69.4% occurred within 180 days after birth.
In the subgroup of pregnant women between 32 and 36 weeks of gestationAbout 1,500 of them were treated with Abrysvo and 1,500 with a placebo, the vaccine reduced the risk of LRTDn 34.7%, 91.1% lower risk of severe LRTD Compared with placebo, within 90 days of birth. Abrysvo reduced the risk of LRTD by 57.3% and severe LRTD by 76.5% in the first 180 days of life compared with placebo.
The most commonly reported side effects in pregnant women receiving Abrysvo are Pain at the injection site, as well as headache, muscle pain, and nausea. Also, although not frequently reported, a hypertensive disorder (called preeclampsia) developed in 1.8 percent of pregnant women who received Abrysvo, compared with 1.4 percent of pregnant women who received a placebo. In the safety study, pregnant women who received Abrysvo had a higher incidence of low birth weight and infant jaundice than those who received a placebo.
“RSV is a common cause of childhood illness, and infants are among the most vulnerable to severe illness, which can lead to hospitalization,” Marks added. It is a highly contagious virus that can cause respiratory infections in people of all ages.. However, it is the most common cause of lower respiratory tract disease in infants worldwide.
Although RSV often causes cold-like symptoms in infants and young children, It can also cause serious respiratory illnesses such as pneumonia and bronchiolitis (inflammation of the small airways of the lungs). Premature infants younger than six months, infants with chronic lung disease, congenital heart disease, or immunocompromise, and infants exposed to tobacco smoke are at greater risk of the infection becoming more serious.
This viral infection is the second leading cause of death in children under the age of one in the world., leading to as many as 14,000 hospitalizations in Spain, and is the leading cause of hospitalization for lower respiratory infections in children under two years of age. Globally, they account for 33 percent of all pneumonia cases, cause 31 million deaths, and have one of the highest healthcare costs in the world: $3.13 trillion.