Vaccine to protect men and women of all ages from RSV shows promising results in phase 3 trials

respiratory syncytial virus (RSV) may be an uncommon name that would confuse smart kids with spell bees, but lower respiratory tract infections caused by RSV are very common, especially in infants and the elderly. is dangerous to

RSV only causes the common cold in most people, but the lower respiratory version is associated with an estimated 3.6 million hospitalizations and more than 100,000 deaths in children under the age of five annually worldwide.

Among adults age 65 and older, RSV is associated with 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually in the United States. Because so many other deadly lower respiratory tract infections afflict frail older people, it is difficult to determine the number of infections attributed to RSV, especially in institutions, so the numbers are There is width.

There are no licensed vaccines. However, there are many promises, and that is subject to change.

Two research papers published in the April 5 issue New England Journal of Medicine We have published an interim analysis of data from a multicenter international phase 3 clinical trial of what is known as the RSV prefusion F protein-based vaccine (RSVpreF for short).

Both are bivalent vaccines and offer protection against two viral subtypes (subtypes A and B). Both are developed by Pfizer.Results reported in NEJM It has had considerable success in preventing moderate illnesses, especially in the elderly, and severe illnesses in newborns and infants whose mothers were vaccinated during pregnancy. There are very few side effects reported by researchers.

Both studies suffered from really bad timing: they began in 2019 when the COVID-19 pandemic was raging. The seasonal pattern of RSV was significantly altered, resulting in an unusually low infection rate. As a result, neither trial was sufficiently powered to show success for all primary endpoints or subgroups. Confidence intervals were wide.

The Maternal Immunization Study for Safety and Efficacy (MATISSE) trial enrolled 7,392 pregnant women in 18 countries who received either vaccine or placebo between 24 and 36 weeks of gestation (second and third trimester). They were divided into dosed groups.

Beate Kampmann, MD, Ph.D. was the lead author of the results of the MATISSE trial of Pfizer’s RSV vaccine in pregnant women.

preliminary Investigation result Reported by first author Beate Kampmann, MD, Ph.D., Professor of Pediatric Infections and Immunity and Director of the Vaccine Center at the London School of Hygiene and Tropical Medicine, and 40 colleagues, found that the RSVpreF vaccine was “medically attended” to prevent RSV-associated severe Effectiveness against lower respiratory tract inflammation was 81.8% at 90 days after birth and 69.4% at 180 days after birth. Efficacy for non-serious disease was 57.1% for him at 3 months, but the results did not meet predetermined criteria for statistical reliability.

No safety concerns for mothers or children were detected.

The RSV Vaccine Efficacy Study in Older Adults Immunized Against RSV Disease (RENOIR) trial enrolled 35,971 adults aged 60 and over in seven countries. RENOIR, like MATISSE, was a double-blind, randomized, placebo-controlled trial.

Edward E. Walsh, M.D., was the lead author of the results reported from the RENOIR trial of Pfizer’s RSV vaccine in the elderly.

preliminary Investigation result Reported by first author Edward E. WalshMD, Professor of Medicine at the University of Rochester and Director of Infectious Diseases at Rochester General Hospital, and 30 colleagues demonstrated 66.7% efficacy for RSV-associated lower respiratory tract disease with at least 2 signs or symptoms, It showed 85.7% efficacy against diseases with 3 signs or symptoms. or more signs or symptoms.

Severely ill cases (hospitalization and illness requiring oxygen or ventilation) were too few to meet the pre-determined cutoffs for statistical significance and were not included in the analysis. I did. Subgroup analyzes based on age (60 to 69, 70 to 79, or ≥80 years) and risk status (no high-risk conditions versus one or more) also yielded similar results, although The youngest group had significantly more participants than the other groups, with wide confidence intervals.

The RSVpreF vaccine group reported more local vaccine site reactions than the group receiving placebo, but similar systemic reactions. Serious adverse events were similar (2.3% in each group), with one case of Guillain-Barre syndrome onset 6 days after injection and one case of Miller-Fischer syndrome (a subset of Guillain-Barré syndrome) onset 8 days after injection. ) is related to the intervention and requires further study. Both study volunteers made a large or complete recovery.

accompany editorial To Ruth A. CaronWhile the M.D., Ph.D., professor in the Department of Global Health at the Johns Hopkins Bloomberg School of Public Health and director of the Center for Immunization Research was commendable, Karon noted that “substantial resources to guide decision-making and implementation are essential.” additional work is essential,” he warned.

Subsequent analyzes based on additional data are particularly important given the number of pandemic control participants that robbed both studies of producing statistically significant results for some endpoints in the interim data. “We are only the beginning of the end,” Karon concluded.

Pfizer sponsored, designed and conducted both trials. I was responsible for data collection, analysis and interpretation. The first draft of the manuscript was written by his Pfizer-paid medical writers under the direction of more than 70 of his authors, many of whom are affiliated with Pfizer. The article stated that all data are available to the authors.

Pfizer is leading the race to bring an RSV vaccine for pregnant women to market. I have written last month of Managed Healthcare ExecutiveThe drug company has indicated it plans to submit an application for FDA approval of the RSVpreF vaccine to protect newborns and infants. The competition for vaccines that protect the elderly is much more intense.