FDA Approves First RSV Vaccine for Pregnant Women to Protect Newborns
The U.S. Food and Drug Administration (FDA) has recently granted approval for the first vaccine against respiratory syncytial virus (RSV) to be administered to pregnant women. The vaccine, developed by Pfizer, will provide protection to newborns by inoculating the fetus against the dangerous lung disease.
RSV is a virus that typically affects infants and leads to severe respiratory symptoms. Every fall and winter, hospitals are filled with wheezing babies suffering from RSV. However, with the approval of Pfizer’s vaccine, babies can now be protected against RSV from birth.
Newborns are most vulnerable to severe RSV infections during the first six months of their lives. Therefore, the introduction of this vaccine serves as a crucial preventative measure. The vaccine, known as Abrysvo, has been shown to guard against severe RSV infections and is expected to have a significant impact on reducing hospitalizations and doctor visits related to RSV in infants.
Maternal vaccination has proven to be highly effective in protecting infants against various infections. Pregnant women are commonly advised to receive flu and whooping cough vaccines, as well as more recently, COVID-19 shots. The RSV vaccination treatment works by administering a single injection to the mother late in pregnancy.
This provides sufficient time for the mother to develop antibodies, which are then passed on to the fetus, offering protection at birth. It is similar to the process through which pregnant women transfer defense against other infections. In an international study conducted by Pfizer involving nearly 7,400 pregnant women and their babies, maternal vaccination using Abrysvo was found to be 82 percent effective in preventing severe RSV cases during the first three months after birth. Its effectiveness remained at 69 percent against severe sickness at six months of age.
The vaccine reactions reported in the study were mostly mild, including tiredness and pain at the injection site. There was a small difference in early birth between vaccinated mothers and those given an inactive shot; however, Pfizer attributes this outcome to chance. To minimize the risk of early birth, the FDA advises that the vaccination should take place between 32 and 36 weeks of pregnancy.
Apart from maternal vaccination, another method to safeguard babies against RSV is the administration of lab-made antibodies. The FDA has also approved a new drug called Beyfortus for all infants under eight months old. This single-dose treatment, developed by Sanofi and AstraZeneca, will be available in the upcoming fall.
Experts suggest that a combination of these treatments may be employed by doctors when they become available. The success of these interventions relies on a sufficient number of pregnant women getting vaccinated. Pfizer estimates that widespread vaccination could prevent up to 20,000 infant hospitalizations and 320,000 doctor visits related to RSV in the United States annually.
Dr. Maria Deza Leon, a doctor at Cincinnati Children’s Hospital who participated in Pfizer’s vaccine study while pregnant, emphasized the importance of protecting infants from RSV. Having cared for seriously ill RSV patients, Dr. Deza Leon highlights the relief of knowing her son, Joaquin, has not experienced a confirmed case of RSV since receiving the vaccine.
Overall, the FDA’s approval of the RSV vaccine for pregnant women represents a significant milestone in ensuring the health and well-being of newborns. By providing protection against RSV at birth, this vaccine has the potential to save countless lives and reduce the burden on healthcare systems during RSV seasons.
