The race for RSV vaccine approval: URMC researchers leading the way

The US Food and Drug Administration (FDA) is currently considering two candidate vaccines to prevent respiratory syncytial virus (RSV) in the elderly. Researchers at the University of Rochester Medical Center (URMC) are leading the development of a vaccine developed by Pfizer. New England Journal of Medicine (NEJM). Of the four adult RSV vaccine candidates (two under FDA review and two in late-stage clinical trials), URMC is involved in three of the studies.

RSV in the elderly is an increasing concern. According to the CDC, it is estimated that between 60,000 and 120,000 people are hospitalized each year and between 6,000 and 10,000 die from their RSV infections among adults over the age of 65. The severity of RSV disease may increase with comorbidities such as chronic obstructive pulmonary disease, congestive heart failure, asthma, and with age. Along with COVID and influenza, RSV has contributed to the ‘triple disease’ that has overwhelmed the country’s healthcare system over the past few months.

Previous studies have shown that RSV infection does not confer sustained immunity thereafter and reinfection can occur throughout life. , researchers are on the brink of approval after a vaccine development effort.

Edward Walsh, M.D., Professor of Medicine, has a long history with Pfizer and has worked on multiple viral pathogens over the years. Appointed lead site along with Walsh as Principal Investigator. In late February, Pfizer published efficacy and safety data from its clinical trials in her NEJM article for submission to the FDA and the Vaccines and Related Biological Products Advisory Committee (VRBPAC). Walsh was also the principal investigator of a pilot study prior to a Phase 3 trial.

Promising results show that Pfizer’s vaccine is 66.7% effective in preventing common illnesses, 85.7% effective in preventing lower respiratory tract infections with 3 or more symptoms, and 85.7% effective in preventing acute respiratory infections. It shows that it is 62.1%. After presenting full data, VRBPAC voted in favor of recommending approval of this vaccine to the FDA.

‘RSV is the worst disease no one knows,’ said co-researcher Anne Falsey, M.D.co-director UR Vaccine Treatment and Evaluation Unitpart of the National Institute of Allergy and Infectious Diseases (NIAID) network, helped research the first FDA-approved COVID vaccine. has started receiving a lot of headlines, but it consistently causes a significant number of hospitalizations and deaths in people aged 65 and over each year.”

Falsey plays a key role in RSV vaccine development at URMC.She recently announced the results of a Phase 2 clinical trial New England Journal of Medicine article On the safety and efficacy of another RSV vaccine for older adults. At another of her FDA/VRBPAC meetings to review GlaxoSmithKline’s (GSK) vaccine candidates, Falsey was not involved in any clinical trials, but presented as an expert at the meeting to share her RSV with the community. I have testified to the burden.

Both Walsh and Falsey have been prominent vaccine researchers for decades. Walsh has studied RSV since the 1980s and describes her epidemiology and clinical features of RSV in adults, with an emphasis on high-risk older populations. His early work was the first to identify and characterize the RSV fusion (F) protein used in current vaccine candidates. Falsey has been involved in clinical and translational his vaccine research for adult respiratory viral infections including RSV, influenza, COVID, parainfluenza, human his metapneumohi virus. She is a permanent member of the Clinical Research and Field Her Research Studies Section and a member of the Steering Committees of the Global Influenza Initiative, the Infectious Diseases Society of America, and the American Society for Virology.

Walsh and Falsey were at the forefront COVID vaccine FDA approvalThey applied the lessons learned from that era to the development of RSV. “We can now run large-scale clinical trials much faster,” said Walsh.

Like most current flu and COVID vaccines, this RSV vaccine does not contain live virus. Instead, as its name suggests, it contains a fusion protein that “protrudes” from the surface of RSV and helps it fuse with the host cell. As a backup, this version of the vaccine also contains a small amount of viral DNA that tells cells how to make the RSV fusion protein. RSVpreF is a bivalent recombinant protein subunit vaccine composed of equal amounts of stabilized prefusion F (preF) antigens from the two major RSV subgroups, RSV A and RSV B.

Unlike influenza and COVID vaccines, which need to be updated frequently to keep up with viral mutations, Pfizer’s RSV vaccine candidate has broad immunity. RSV fusion proteins used in vaccines can protect against many different RSV strains. The protein has two forms that change shape before and after fusion with the cell. Previous clinical trials showed that postfusion-based vaccines were insufficient to generate strong immune responses and failed to prevent RSV disease. Subsequent trials have shown that pre-fusion vaccines elicit stronger immune responses, so current vaccines are based on pre-fusion proteins.

An FDA decision is expected in the coming months.