Abrysvo: The FDA Approved Vaccine for RSV in Pregnant Women

The FDA recently approved a new vaccine for RSV (Respiratory Syncytial Virus), a common but potentially serious illness in infants. This ground-breaking vaccine is named Abrysvo and is designed to be administered in expectant women to protect their newborns against the virus.

It's every parent's nightmare to see their precious little one suffering from any type of disease, let alone one that affects their ability to breathe. Diseases such as Respiratory Syncytial Virus (RSV), commonly associated with infancy, can induce an alarming amount of fear and anxiety in parents.

However, the good news recently announced by the Food and Drug Administration (FDA) may just ease the prevalent anxiety that many parent-to-be harbour. They’ve approved the first-ever RSV vaccine for administration in pregnant women. This vaccine known as Abrysvo, aims to safeguard newborn babies against RSV from birth to 6 months of age, especially preventing lower respiratory tract disease (LRTD) triggered by this virus.

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LRTD can occasionally take a severe form of RSV, making the arrival of this vaccine a significant medical development. Leading medical professionals, including infectious disease specialist, Oluwatosin "Tosin" Goje, M.D., at the esteemed Cleveland Clinic, have welcomed this development citing, “RSV is the leading cause of infant hospitalization and the vaccine was found to prevent severe infection and hospitalization".

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RSV itself isn’t an uncommon virus. It's usually passed around like a common cold and in most cases, babies experience mild symptoms for a week or two, such as a fever and cough. However, for those with a higher risk of severe RSV, particularly infants born prematurely or with heart or lung ailments, it could lead to serious complications like pneumonia or bronchitis.

The shift introduced by the recent approval of Abrysvo, the new RSV vaccine, is nothing short of monumental. Made to be administered during pregnancy, it is designed to thwart serious future respiratory illnesses in newborns. It is conceived as a single-dose shot given late in pregnancy, ideally between week 32 and week 36.

The vaccine trails yielded promising outcomes. According to Dr. Goje, it's particularly effective when it comes to preventing severe lower respiratory tract disease caused by RSV. The vaccine reduced the risk of severe LRTD by an impressive 82 percent within three months of birth.

Even before this breakthrough, Abrysvo already laid out a proven track record. In May of 2023, this vaccine, along with a secondary RSV vaccine, was officially approved for adults aged 60 and above. The Centers for Disease Control and Prevention (CDC) encourages individuals in this age category to consult their physicians regarding its usage.

Why is the approval of an RSV vaccine for administration during pregnancy so revolutionary? While the majority of RSV cases are mild, there's a substantial number that can be life-threatening. RSV has been identified as the main cause of severe bronchiolitis in children under one year old, with 2 or 3 out of 100 babies younger than 6 months possibly requiring hospitalization for oxygen assistance.

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As if that wasn't enough, there was a significant surge in RSV cases last year, likely due to the increased use of masks and quarantining during 2020 and 2021. This saw young babies and older kids contracting RSV in record numbers. This is partly why the vaccine's approval was so timely and pivotal.

RSV is undoubtedly a significant concern, but the question remains - is the new RSV vaccine safe for you and your baby during pregnancy? To put it simply, yes. According to Dr. Goje, "No safety signals were detected in the mother and baby", which indicates no evidence of complications linked to the injection in the pregnant mother or her baby during the clinical trials.

To determine its safety and effectiveness, international clinical trials were conducted, including thousands of pregnant women in randomized, placebo-controlled studies. These yielded extremely encouraging results. The tests showed that out of 3,500 women who received the vaccine, the risk of severe LRTD was reduced by about 82 percent within the first 90 days after birth.

In a subgroup of 1,500 pregnant women, the effectiveness of the vaccine was even more conspicuous, with the risk of severe illness reduced by an astounding 91 percent in the first three months. By the sixth month, the rate of severe respiratory disease was down by about 77 percent.

The RSV vaccine is developed to be administered during the third trimester of pregnancy. The average administration in the clinical trials was around 30 weeks pregnant. The recommended timeframe of between 32 to 36 weeks for the vaccine's use is partly designed to minimize side effects. However, the precise schedule for when the vaccine will be available in doctor's offices has not yet been finalized but speculation suggests it could be as soon as October 2023.

The new RSV vaccine, Abrysvo, is approved for pregnant women during their third trimester. However, there are certain groups of people for whom it's not recommended. As Dr. Goje explains, "For this particular vaccine, the study excluded high-risk pregnant mothers". If you're allergic to any part of the vaccine or if you're at risk for a premature delivery, the RSV vaccine may not be the best fit for you.

In terms of adverse outcomes, a small percentage who received the vaccine experienced conditions such as pre-eclampsia, a hypertensive disorder. Instances of low birth weight, jaundice, and premature birth were also slightly more common in those who received Abrysvo. However, common side effects reported include pain and rash at the site of the injection, headache and muscle pain, and nausea.

RSV usually results in mild illness in babies and children, but the risks are still present. Hence, the development of a preventative vaccine is indeed commendable. It is fundamental to talk to your doctor about the new RSV vaccine so you can evaluate whether receiving it during your pregnancy is the best course of action for your situation.