GSK announced on Friday that the Food and Drug Administration has authorized its respiratory syncytial virus vaccine for those under 50 who are at a higher risk of severe RSV, making it the first shot approved for use in this age group to protect against RSV.
GSK, a global vaccine and pharmaceutical, sought the FDA in February to widen clearance beyond individuals 60 and older, claiming evidence indicating that the immune response in adults immunized at this lower age range was equivalent. GSK stated that they will conduct additional trials on adults aged 18 to 49, anticipating findings in the second half of this year.
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Two additional businesses, Pfizer and Moderna, offer licensed RSV vaccinations for individuals over 60 and are currently conducting studies on younger adults. Last month, Pfizer informed investors that it was preparing to present “positive” data from its own shot-down tests to age 18.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will need to approve GSK’s vaccine for individuals aged 50 to 59. Their support at upcoming meetings in June or October would ensure insurance coverage.
Adults in their 50s are expected to gain from RSV vaccination, according to a study group inside the CDC’s committee that concluded last year ahead of the approval, though the benefit is narrower than for older adults, who are at higher risk simply due to their age.
Pre-existing medical difficulties are more likely to increase the risk of RSV infections becoming dangerous for people under the age of 60.
“A lot of sickness occurs because the virus activates your underlying medical issues, such as COPD, heart failure, etc. So the virus is more of a trigger for exacerbation,” explained Dr. Phil Dormitzer, GSK’s senior vice president and global head of vaccine research and development.
Dormitzer reported that GSK’s vaccine has yielded “relatively comparable” safety results in this group when compared to individuals 60 and older. Some of the vaccine’s negative effects appeared to be worse, perhaps due to improved immune responses in this age group.
The CDC panel has already dealt with uncommon but significant cases of Guillain-Barré syndrome, a neurological condition associated with the use of RSV injections.
Last week, the CDC reported approximately 1.5 cases of the condition per million doses of GSK’s vaccine. The agency’s survey statistics show that since the RSV vaccine’s licensing last year, about a fifth of people aged 60 and older have received it.
According to Dormitzer, GSK’s trials found no “concerning” trends in GBS incidence among those aged 50 to 59.
“GBS is another danger that seems to increase with age. However, there is little evidence to suggest that GBS poses a specific risk,” he stated.
The CDC panel will also decide whether and when to administer RSV booster injections to individuals.
Dormitzer stated that GSK intends to deliver more study results to the CDC committee in June, including boosters spaced out up to three years after an initial dose.
“This is an extremely important question. People assumed it would have to be an annual vaccine. However, we discovered that the length of protection is significantly longer than one season,” he stated.
