New RSV vaccine for pregnant people promising, Cincinnati Children's doctor says

A new vaccine given to pregnant people to protect their newborns from respiratory syncytial virus appears to be on the horizon, and a Cincinnati Children's Hospital Medical Center investigator for the clinical trials on the immunization says the results are positive.

Pfizer announced Tuesday that it plans to apply for Food and Drug Administration approval for the vaccine by the end of the year.

"I was excited to get the news this morning," said Dr. Elizabeth Schlaudecker, who is overseeing the vaccine clinical trial at Cincinnati Children's Schubert Research Clinic. She is the medical director of the center's division of infectious diseases.  She is among investigators in 18 countries who've been involved in the clinical trials for the RSV vaccine.

Beth, a participant in an RSV vaccine trial, speaks to lead investigator Dr. Elizabeth Schlaudecker, a faculty member of the division of infectious diseases and the Global Health Center at Cincinnati Children's Hospital Medical Center.
Beth, a participant in an RSV vaccine trial, speaks to lead investigator Dr. Elizabeth Schlaudecker, a faculty member of the division of infectious diseases and the Global Health Center at Cincinnati Children's Hospital Medical Center.

Pfizer announced that vaccine efficacy of 81.8% was observed against severe, medically attended lower respiratory tract illness due to RSV in infants from birth through the first 90 days of life.

"We still are following these babies to see whether or not they develop RSV," Schlaudecker said.

The check on data was preplanned and is not related to the coincidental surge in RSV that children's hospitals across the United States are seeing, Schlaudecker said. "They'll keep gathering data," she added.

Tiny airways become inflamed by RSV

As an infectious disease expert and pediatrician, Schlaudecker knows firsthand the troubling complications that can happen when infants and young children get respiratory syncytial virus. Their tiny airways may become inflamed, mucus and infection-fighting cells can build up, she told The Enquirer in February.

A vaccine for pregnant people is ideal, Schlaudecker said, because it protects newborns during their vulnerable first days and months, when they do not have a strong immune system.

She said a lot of people did not or do not know much about RSV. "It's very hard to say and spell," and it's something that parents often learn when their child is diagnosed.

The symptoms can be "scary" for parents, she said, as they watch their infant struggle to breathe. For pediatricians and infectious disease doctors, the illness is frustrating, Schlaudecker said, because they can only help kids with supportive care because there is no specific medical treatment for the virus.

What to know about RSV: What every parent should know about respiratory syncytial virus

"It's one of our greatest foes," she said.

Cincinnati Children's sees continuing surge in respiratory illnesses

This year, pediatricians and children's hospitals are seeing RSV earlier than a typical surge, in December to January, Schlaudecker said. The current surge is believed to have occurred in part at this time because of COVID-19 pandemic restrictions, which prevented people from having typical immunity levels because they were distanced from others to stop the spread of COVID-19.

Cincinnati Children's does not release data on emergency department visits or hospital admissions, but noted on Oct. 21 it was seeing longer wait times at the emergency department and urgent cares because of a surge in kids with respiratory illnesses. The hospital encourages parents and other caregivers to check with their child's pediatrician before coming to the emergency department, and Schlaudecker said the hospital has close ties to the pediatric providers.

Cincinnati Children's has several ways of maintaining its level of care for its patients, she said. One example: Adults sometimes show up at the emergency department, but the hospital asks primary care providers to refer adults to adult hospitals. In addition, she said, "We have lots of things in place that we had during COVID. We were strained and we learned how to work really hard to see patients in a safe and effective way."

Hospital staff is trained to act when the "unknown" presents itself, Schlaudecker said. "We don't turn people away."

This article originally appeared on Cincinnati Enquirer: Pfizer RSV vaccine shows promise says Cincinnati Children's