FDA advisors back RSV vaccines from Pfizer and GSK
There are currently no approved vaccines for RSV: but Pfizer and GSK’s candidates are set to become the first for the 60+ age group after the Vaccine and Related Biological Products Advisory Committee votes this week.
Pfizer’s vaccine – which reported efficacy of 85.7% in Phase 3 trials – received a vote 7-4 in favor from the committee (with one abstention) when asked to assess efficacy and safety of the vaccine.
For GSK’s vaccine – which reported similar efficacy of 82.6% in trials - the committee voted unanimously in favor of its effectiveness and 10-2 in favor of its safety profile.
Committee members highlighted that Guillain-Barre cases had occurred during the trials of both vaccines. Pfizer’s trial data reported a case of Guillain-Barre syndrome and a case of Miller Fisher syndrome (a variant of Guillain-Barre syndrome); leading the FDA to request that Pfizer includes Guillain-Barre and other immune-mediated demyelinating conditions in its Pharmacovigilance Plan (PVP) as an important potential risk; as well as set out plans for a postmarketing safety study.
GSK’s study contained one case of Guillain-Barre syndrome. The FDA’s review of GSK’s proposed pharmacovigilance plan is ongoing.