Preliminary results of clinical trials show RSV vaccine protects newborns from severe illness

Minnesota is playing a role in clinical trials for the first-ever vaccine against respiratory syncytial virus, or RSV.

RSV is a highly contagious virus that can infect the lungs and airways, making it difficult for a person to breathe.

The virus can be especially dangerous for children under the age of 2, older adults, and people with certain medical conditions.

RELATED: Flu, RSV hospitalizations jump in Minnesota

This week, pharmaceutical company Pfizer released preliminary results from a phase three clinical trial of their RSV vaccine, which is a traditional protein-based vaccine that would be given to pregnant women.

The study enrolled 7,400 pregnant women in 18 countries.

The participants were given a shot in the late second to third trimester of pregnancy, administered either a single dose of the RSV vaccine candidate or a placebo.

Allina Health participated in the clinical trial at its site in Coon Rapids, following one pregnant woman from Minnesota and her baby.

Dr. Frank Rhame led the local study.

“Where I think it will make the big difference is the severe end of the spectrum because it does look like those antibodies are protective against severity of illness, even though they don’t look like they’re as protective against getting a less severe infection,” Rhame said. “But it’s going to do good at preventing the severe end of the spectrum, which is what you really care about.”

According to Pfizer, the vaccine showed 82% efficacy in preventing severe sickness during the most vulnerable first 90 days of a baby’s life and 69% efficacy through the first six months. 

The company reported that there were no signs of safety problems in mothers or their newborns after being vaccinated.

“With so many participants, we are going to get good safety data,” Rhame said. 

Rhame believes if the vaccine gets approval, it could be a game-changer during the cold and flu season.

“Oh, for RSV, it’s going to be a huge change,” Rhame said.

This year, Minnesota is seeing an early spike in RSV.

According to the Minnesota Department of Health, nearly 180 people statewide are hospitalized with the virus, more than doubling the number of hospitalizations since last month.

It comes at a time when hospitals in the metro are already full and dealing with low staffing.

There are only two pediatric intensive care beds available in the metro right now, according to state data.

Janelle Westphal’s daughter Melanie was recently hospitalized with RSV.

She said her family had to spend the first night in the emergency room because there were no beds available.

Her eight-month-old was struggling to breathe with low oxygen levels due to RSV.

“As a mom, I think my first thought was, is she going to make it?” Westphal said. “It was definitely a scary experience.”

Her daughter Melanie needed high-flow oxygen and spent four days in the hospital.

The hospitalization and weeks-long recovery has been financially challenging for the family. There is a GoFundMe page set up to help them, and you can donate by clicking here.

Melanie is now recovering at home.

The family said they hope a new vaccine could help prevent other children from getting as sick as their daughter was with RSV.

“If they could come out with something that would help, that would be amazing,” said Dylan Brill, Melanie’s father.

Pfizer plans to submit a Biologics License Application for their RSV vaccine candidate to the FDA by the end of 2022.

Rhame said he is hopeful it could become widely available before next fall’s RSV season.