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First RSV Vaccine for Pregnant Women Approved, Promising Newborn Protection Against Dangerous Lung Disease

By: GWL Team | Tuesday, 29 August 2023

In a historic achievement, the first-ever respiratory syncytial virus (RSV) vaccination created especially for pregnant women has received approval from the American food and drug administration. Abrysvo, a ground-breaking vaccine, aims to protect foetuses and offer vital defence against the dangerous lung illness starting at birth.

Hospitals are inundated with infants who are wheezing during the autumn and winter because of the respiratory syncytial virus, or RSV. The multinational pharmaceutical company Pfizer has emerged as a pioneer in this effort, and its recently approved vaccine is expected to transform early-life immunity. An infant's vulnerability to severe RSV infections, which lasts from birth through the first six months of life, will be protected by the vaccination.

The duty of creating recommendations for the use of Abrysvo during pregnancy has now been given to the Centres for Disease Control and Prevention. Participating in Pfizer's global trial of the vaccine, Dr. Elizabeth Schlaudecker from Cincinnati Children's Hospital in Ohio praised maternal immunisation as a ground-breaking strategy for protecting infants. Dr. Schlaudecker expressed confidence and said that if vaccines started right once, the forthcoming RSV season may see a noticeable difference.

RSV, a typically minor illness in healthy people, poses serious hazards to babies. Babies who contract the virus have swollen airways, which can cause respiratory discomfort and possibly pneumonia. RSV causes between 58,000 and 80,000 children under the age of five to be hospitalised each year in the United States, leading to several hundred fatalities.

The fact that kids are born with a weakened immune system and significantly rely on their mothers for disease resistance in the first few months of life highlights the importance of maternal protection. A single injection is used during the immunisation procedure towards the end of pregnancy, giving the mother plenty of time to produce antibodies. The foetus receives these protecting substances after which they become active at birth.

This strategy is similar to the routine of immunising pregnant women against various illnesses, such as the flu, whooping cough, and more recently, COVID-19.

The maternal immunisation might not prevent mild RSV infection, but Pfizer's study, which included nearly 7,400 pregnant women and their babies, found that it showed a remarkable 82 percent efficacy in avoiding severe infections during the first three months after birth. The efficacy against serious illness was 69% for the first six months of the protection.

Fatigue and localised soreness at the injection site were the main adverse responses to the vaccination. Notably, the FDA advised immunisation between weeks 32 and 36 of pregnancy to reduce the minor potential of an early delivery, which was noted in a tiny percentage of moms who received the vaccine in the trial.

If a sizable proportion of expectant mothers choose immunisation, Pfizer estimates that up to 20,000 baby hospitalisations and 320,000 medical visits might be avoided yearly.

The delivery of lab-made antibodies to babies is an alternative method of RSV protection. Beyfortus, a brand-new medication made specifically for newborns under 8 months of age, has just received approval from the U.S. Food and Drug Administration. This single-dose medication, which is produced by Sanofi and AstraZeneca, is predicted to be on sale in the next autumn.

To maximise newborn protection against RSV, doctors, including those from Cincinnati Children's Hospital, want to combine these cutting-edge therapies. Dr. Maria Deza Leon recounted her personal experience and emphasised the seriousness of RSV infections in newborns while actively taking part in Pfizer's vaccination research while expecting.

Dr. Deza Leon is still optimistic about the future because her son Joaquin was born a month after she had the vaccination, allaying parents' worries about their children's health.