In a groundbreaking development, U.S. regulators have granted approval for the first ever vaccine against respiratory syncytial virus (RSV) for pregnant women. This vaccine, called Abrysvo and manufactured by Pfizer, aims to protect infants from severe cases of RSV during their first six months of life. RSV is a particularly dangerous respiratory infection that often leads to hospitalizations and even death among babies, especially during fall and winter seasons.
Before the vaccine can be widely used, the Centers for Disease Control and Prevention (CDC) must issue guidelines for its administration during pregnancy. It is worth noting that vaccinations for older adults, who are also at high risk for RSV, have already commenced this fall using the Pfizer shot in combination with a competitor’s vaccine from GSK.
Dr. Elizabeth Schlaudecker, a researcher from Cincinnati Children’s Hospital who participated in Pfizer’s international study on the vaccine, hails maternal vaccination as an incredible method to protect infants. She asserts that if vaccinations begin soon, there could be a tangible impact on this RSV season.
While RSV typically manifests as a common cold in healthy individuals, it can be life-threatening for young babies, causing inflammation in their airways and leading to breathing difficulties or pneumonia. In the United States alone, between 58,000 and 80,000 children under the age of 5 are hospitalized annually due to RSV, with several hundred deaths reported.
Last year’s RSV season in the U.S. was particularly severe, with cases occurring much earlier than usual, even during the summer. Therefore, the approval of the RSV vaccine for pregnant women is a significant development in safeguarding infants from this infectious disease.
Babies are born with an underdeveloped immune system and rely on their mothers for protection during the first few months of life. Through a single injection in late pregnancy, the mother-to-be can develop antibodies that are transmitted through the placenta to the fetus, providing immediate immunity upon birth. This method is similar to how pregnant women pass on protection against other infections like the flu, whooping cough, and more recently, COVID-19.
Pfizer’s study involved nearly 7,400 pregnant women and their babies. While the vaccine did not prevent mild RSV infections, it demonstrated an impressive 82% effectiveness in preventing severe cases during the first three months of life. By the sixth month, effectiveness against severe illness remained at 69%.
The most common reactions to the vaccine were localized pain and fatigue at the injection site. The study also found a slight increase in premature births, but Pfizer attributes this to chance rather than the vaccine. To mitigate any potential risk, the FDA recommends administering the vaccine between 32 and 36 weeks of pregnancy, a few weeks later than in the clinical trial.
Pfizer estimates that widespread maternal vaccination could prevent up to 20,000 infant hospitalizations and 320,000 doctor visits related to RSV in the United States each year, highlighting the significant impact it could have on public health.
Currently, the only other option for protecting babies from RSV is through lab-made antibodies. The FDA recently approved a new drug called Beyfortus, developed by Sanofi and AstraZeneca, which is a one-dose version recommended for all infants under 8 months of age before their first RSV season begins. This drug is expected to be available this fall.
Experts anticipate that a combination of the new antibody drug and the maternal vaccine will likely be used to provide optimum protection for babies based on their age and individual risk factors during the RSV season.
Dr. Maria Deza Leon, a physician from Cincinnati Children’s Hospital who participated in Pfizer’s vaccine study, emphasized the importance of protecting children from RSV and preventing the distressing experience of watching a child struggle to breathe. Having received the vaccine during her own pregnancy, she can attest to the peace of mind it offers knowing that her son has been safeguarded from RSV.
Overall, the approval of the RSV vaccine for pregnant women marks a significant step forward in the fight against this respiratory infection. With proper administration and widespread adoption, it has the potential to significantly reduce hospitalizations and morbidity rates among infants. This development, coupled with the introduction of the one-dose antibody drug, provides new hope in ensuring the well-being of young children during RSV seasons. The Associated Press Health and Science Department is solely responsible for the content of this article.
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