RSV Breakthrough: FDA Approves First Vaccine for Newborns, Tackling a Persistent Threat

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The Food and Drug Administration (FDA) has granted approval to the inaugural RSV vaccine intended for pregnant women, aiming to safeguard their newborns.

Administered during the final trimester of pregnancy, Pfizer’s novel vaccine – named Abrysvo – shields infants against respiratory syncytial virus (RSV) and the resulting lower respiratory tract illness, throughout their initial six months of life.

RSV’s Impact and Hospitalization Rates: A Grave Concern

RSV is a prevalent respiratory virus often causing mild symptoms, but it can pose a significant threat to infants, young children, and older adults. Every year, as many as 80,000 children under the age of 5 require hospitalization due to RSV, as reported by the Centers for Disease Control and Prevention (CDC). This makes RSV the primary cause of hospitalizations among infants.

Dr. Scott Roberts, an assistant professor of infectious diseases at Yale School of Medicine, notes, “RSV has been a persistent concern for the infant population, not just in the United States but globally, for a considerable time.”

In May, a committee of advisors within the FDA expressed unanimous support for the vaccine’s effectiveness. Typically, the FDA aligns with the committee’s decisions to approve drugs, although this isn’t always the case.

A study encompassing 7,400 women across 18 countries revealed that the vaccine demonstrated an 82% effectiveness in preventing severe infant disease within the initial three months of life and a 70% effectiveness within the first six months.

“Efforts to develop vaccines and treatments for RSV have faced setbacks for many decades,” Roberts comments. “A lot of us within the medical community are entering the upcoming winter season with a sense of hope and excitement, knowing that we now have various options on the horizon.”

The previous year witnessed an earlier-than-expected RSV outbreak that overwhelmed numerous children’s hospitals, highlighting how a severe season can strain the country’s capacity to care for critically ill children.

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RSV Prevention on a Global Scale: Impact Beyond Borders

Dr. Eric Simoes, affiliated with the Children’s Hospital Colorado, collaborated with Pfizer and has dedicated decades to RSV prevention efforts. He describes this approval as truly exciting news.

“My sole aspiration is to ensure that these vaccines reach not only children in the U.S. but also those in developing nations who are in dire need,” Simoes emphasizes.

This year, RSV activity has already kicked off in states like Florida and Georgia, as reported in the newsletter “Force of Infection” by Dr. Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

Originally sanctioned for adults over 60 in May, the vaccine is now ready for the 2023-24 RSV season. Pfizer confirms it has been manufacturing the vaccine in advance of approval and anticipates having an ample supply to meet the demand.

Dr. Roberts expresses a heightened sense of optimism, particularly because his family is expecting a baby in December, right around the typical peak of the RSV season. With these developments, they now have several protective options to consider.

“The unique aspect about RSV is that it strongly impacts healthy infants. In most cases, regardless of any pre-existing conditions, we see children being admitted to hospitals due to RSV-related illness, and unfortunately, some of them, who are otherwise perfectly healthy, do not survive,” he explains. “This is something that deeply troubles me.”