The Respiratory Syncytial Virus (RSV) is a common and severe infection that affects infants, often leading to serious lung inflammations that can be life-threatening. Fortunately, there’s a new solution on the horizon: the U.S. Food and Drug Administration (FDA) has granted approval for a new Pfizer vaccine designed specifically to protect infants during their early months. This groundbreaking vaccine can be administered to pregnant women, with the aim of safeguarding newborns from RSV.
Typically, RSV causes mild symptoms such as coughing in most cases. However, in high-risk populations like infants and the elderly, it can escalate to become extremely aggressive, resulting in breathing difficulties, respiratory pauses, and even life-threatening situations. RSV tends to surge during the fall and winter months and is a leading cause of hospitalizations for respiratory illnesses among infants and the elderly.
The newly approved vaccine, known as Abrysvo, has already been greenlit for use in adults aged 60 and older to prevent a respiratory illness that claims approximately 160,000 lives globally each year. Now, the FDA has expanded its approval to allow pregnant women to receive the vaccine between weeks 32 and 36 of pregnancy, providing protection to their unborn children. The antibodies generated through this vaccination process will shield the newborn upon birth, offering vital protection for at least the first six months of life – a critical period during which even a minor infection can pose a serious risk to the infant.
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The FDA’s decision to authorise this expanded use of the vaccine was informed by an advanced-stage clinical trial involving roughly 7,000 pregnant women. The trial results demonstrated that the vaccine was effective in preventing severe infections in infants, boasting an impressive efficacy rate of 82% when administered to expectant mothers during the latter half of their pregnancies. Pfizer has reported that the most common side effects experienced by women who received the vaccine included fatigue, headaches, pain at the injection site, muscle aches, nausea, joint pain, and diarrhoea.
Just a little over a month ago, the FDA also granted approval for a new RSV vaccine for infants, which offers the convenience of a single-dose administration, as opposed to the previous requirement of five doses. This vaccine, named Beyfortus, is anticipated to become readily available worldwide in the coming weeks. The Israeli Pediatric Association has already recommended its approval by the Israeli Health Ministry. Additionally, several months ago, the FDA approved two additional RSV vaccines specifically intended for the elderly population.
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