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US Approves Vaccine to Protect Babies in Womb - Cord Blood

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US Approves Vaccine to Protect Babies in Womb

Photo of a scientist looking at test tubes in a laboratory

The United States has made history by becoming the first country to approve a vaccine for pregnant women that protects their babies from severe disease caused by Respiratory Syncytial Virus (RSV). The Pfizer vaccine, which was already approved for older adults, can now be given to pregnant women as a single injection between 32 and 36 weeks of pregnancy.

This will safeguard infants from birth until they are six months old. RSV is a common microbe that leads to many hospitalizations each year, especially among infants and the elderly in the US. The development of the vaccine was made possible by a scientific breakthrough ten years ago.

The approval of the vaccine came after a clinical trial involving 7,000 pregnant women. The trial showed that Pfizer’s vaccine, called Abrysvo, reduced severe disease caused by RSV by 82% in infants aged 0-3 months and 69% in infants aged 0-6 months. The vaccine was already approved for adults aged 60 and over. Another vaccine by the drugmaker GSK, called Arexvy, was also approved for this age group. Although RSV usually causes mild symptoms in infants, it can lead to more serious conditions like pneumonia and bronchiolitis.

Each year, between 58,000 and 80,000 children under the age of five are hospitalized due to RSV, making it the top cause of infant hospitalization. Pregnant patients who received Abrysvo reported common side effects such as pain at the injection site, headache, muscle pain, and nausea. The vaccine did carry a small risk of pre-eclampsia, a dangerous blood pressure disorder, in 1.8% of pregnant individuals compared to 1.4% in those who received a placebo. There was also a slightly higher rate of preterm births in the group that received the vaccine, but the FDA noted that the sample size was small and further research was needed. The FDA has instructed Pfizer to continue studying the risks of preterm birth and pre-eclampsia.

After receiving FDA approval, the vaccine will need clearance from the Center for Disease Control (CDC), which will provide recommendations on the best usage. It is unsure if the vaccine will be available in time for the RSV season in the fall and winter. However, there is another medicine called Beyfortus, developed by Sanofi and AstraZeneca, that has recently been approved as a preventative treatment for babies and toddlers. It works like a vaccine to protect against RSV.