GSK meningococcal vaccine accepted by US FDA for review
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GSK announced on Tuesday that its five-in-one meningococcal ABCWY (MenABCWY) vaccine candidate had been accepted for regulatory review by the US Food and Drug Administration (FDA).
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The FTSE 100 pharmaceuticals giant said the Prescription Drug User Fee Act (PDUFA) action date for the FDA's regulatory decision on the application was set for 14 February 2025.
It said the vaccine candidate, which it developed, offered broad coverage against the five most common groups of bacteria causing invasive meningococcal disease (IMD).
If approved, the vaccine could potentially streamline immunisation protocols by reducing the number of injections required.
The company said the innovative vaccine combines the antigenic components of two established meningococcal vaccines - Bexsero and Menveo - both known for their efficacy and safety profiles.
It said the MenABCWY combination targeted neisseria meningitidis bacteria groups A, B, C, W, and Y, which collectively account for a majority of IMD cases worldwide.
Simplifying immunisation through fewer shots aimed to enhance series completion and vaccination coverage, ultimately reducing the overall burden of IMD.
GSK said adolescents particularly stood to benefit as they were at higher risk of IMD and potential outbreaks.
The company described IMD as a severe and unpredictable illness with potentially life-threatening complications.
Despite treatment, the mortality rate remained significant, while survivors could face long-term consequences such as brain damage and hearing loss.
In the US, where meningococcal vaccine recommendations had covered all five serogroups since 2015, immunisation rates for IMD remained low, partly due to a complex vaccination schedule.
MenB, the most common group of IMD-causing bacteria in US adolescents and young adults, remained a significant concern.
Results from the phase three trial of the MenABCWY vaccine candidate showed promising outcomes, meeting all primary endpoints.
That included immunological non-inferiority to GSK's Meningococcal Groups A,C,Y, and W Vaccine and non-inferior immune responses against a broad range of MenB invasive strains.
The vaccine also demonstrated a favourable safety profile, consistent with both constituent vaccines.
At 0920 BST, shares in GSK were down 1.98% at 1,611p.
Reporting by Josh White for Sharecast.com.