A vaccine to help prevent a leading cause of pneumonia in the elderly has been found effective in late-stage clinical trials. The data will be submitted for review to the Food and Drug Administration later this year, according to its maker.
One dose of GlaxoSmithKline’s experimental vaccine for respiratory syncytial virus (RSV) produced a “strong” immune response in adults aged 60 years and older, the company announced Friday. Protection lasted, remaining above pre-vaccination levels for at least six-months, trial data showed.
An elusive vaccine
More than 177,000 older adults are hospitalized in the United States each year due to an RSV infection and 14,000 die, according to federal data. Mortality rates in severe RSV infections are similar to that of influenza, studies have shown. But a vaccine has remained elusive, and GSK’s clinical trial has been closely watched.
Pfizer, Moderna and Johnson & Johnson are also developing RSV vaccines. J&J’s shot showed 80% efficacy in elders according to clinical trial data announced in October 2021.
GSK’s vaccine uses an antigen plus an adjuvant that may help it to overcome the natural age-related decline in immunity. This decline has complicated efforts to protect older adults from RSV disease, the company noted.
“RSV remains one of the few major infectious diseases without a vaccine,” said Hal Barron, M.D., GSK’s chief scientific officer, in a statement. “Given the importance of these data, we plan to engage with regulators immediately and anticipate regulatory submissions in the second half of 2022.”
RSV in long-term care
Long-term care facilities are subject to outbreaks of RSV, prompting some experts to urge clinicians to take the disease as seriously as they do the flu in these settings. The disease is traditionally associated with young children and its effects on the elderly have recently received focused attention in the United States.
The National Foundation for Infectious Diseases this year released a report calling on clinicians to get up to speed on RSV’s clinical presentation in elders. If therapies are approved, “we need to be prepared to use them appropriately,” NFID medical director William Schaffner, M.D., told McKnight’s Clinical Daily in January.
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