London—In a Twitter tweet in late October, CDC Director Rochelle Walensky, MD, MPH, warned, “Respiratory viruses are on the rise across the United States. Take preventive actions to stop the spread of viruses like flu, RSV, and COVID-19.”
At the same time, media reports described how children’s hospitals around the country were filled to capacity with cases of pediatric RSV.
The American Academy of Pediatrics notes that nearly all children get RSV at least once before they are aged 2 years. While RSV is like a cold for most, some children, especially very young ones, can get very sick. Older adults also can have severe cases of RSV.
The virus occurs in the late fall through early spring months but can vary in different parts of the country.
“With mask-wearing and physical distancing for COVID-19, there were fewer cases of RSV in 2020. However, once safety measures relaxed with the arrival of COVID-19 vaccines, a rise in RSV cases began in spring 2021,” according to the healthychildren.org site. “The spread of RSV and other seasonal respiratory illnesses like influenza (flu) has also started earlier than usual this year.”
Help might be on the way, however, at least for older adults. A presentation at IDWeek 2022 showed overall vaccine efficacy against RSV-lower respiratory tract disease (LRTD) in adults aged 60 years and older, with a favorable safety profile, according to GSK plc.
The UK pharmaceutical company reports:
• Consistent high vaccine efficacy observed against LRTD in severe disease (94.1%) adults aged 70 to 79 years (93.8%) and adults with underlying comorbidities (94.6%)
• High vaccine efficacy is consistent across RSV A and B strains.
“The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% (96.95% CI, 57.9–94.1, 7 of 12,466 vs. 40 of 12,494) against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial’s primary endpoint,” according to a press release.
The company noted that consistent high vaccine efficacy was also observed across a range of prespecified secondary endpoints, highlighting the impact the vaccine candidate could have on the populations most at risk of the severe outcomes of RSV. Efficacy against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee, was 94.1% (95% CI, 62.4-99.9, 1 of 12,466 vs. 17 of 12,494). In participants with preexisting comorbidities, such as underlying cardiorespiratory and endocrinometabolic conditions, vaccine efficacy was 94.6% (95% CI, 65.9-99.9, 1 of 4,937 vs. 18 of 4,861), with 93.8% (95% CI, 60.2-99.9, 1 of 4,487 vs. 16 of 4,487) efficacy observed in adults aged 70 to 79 years.
GSK also advises that vaccine efficacy against LRTD was consistent across both RSV-A and RSV-B subtypes (84.6%; CI 32.1–98.3, 2 of 12,466 vs. 13 of 12,494 and 80.9%; CI 49.4–94.3, 5 of 12,466 vs. 26 of 12,494 respectively).
“These are truly exceptional results given that today RSV remains one of the major infectious diseases without a vaccine, despite over 60 years of research,” stated Tony Wood, GSK chief scientific officer. “We believe that with the high vaccine efficacy demonstrated in this pivotal trial, our vaccine candidate has the potential to help reduce the significant global burden of RSV-associated disease in older adults, including those at the greatest risk of severe outcomes due to their age or underlying comorbidities.”
With no RSV vaccines currently approved anywhere in the world, regulatory submissions based on the phase III data are anticipated in the second half of 2022. GSK’s RSV vaccine candidate for older adults contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E. adjuvant.
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Published November 7, 2022