GSK hits back in 5-in-1 meningitis jab contest with Pfizer

The race to market for a next-generation meningococcal vaccine has gone up a gear once again, with GSK reporting phase 3 results in support of its five-in-one candidate, as it chases down rival Pfizer.

The latest data on its MenABCWY vaccine – which covers all five meningococcal strains in one go as an alternative to separate vaccinations – showed that the shot met all 11 of its primary endpoints, and was at least as effective as the company’s licensed meningococcal vaccines Bexsero and Menveo, given separately with a similar safety profile.

GSK is in a tussle with Pfizer to bring the first MenABCWY vaccine to market, aiming to simplify immunisation schedules by reducing the number of injections needed, and potentially enhance uptake and reduce costs associated with the disease.

The two companies claim that the need to use multiple meningococcal vaccines to provide coverage at present has resulted in confusion among the public and doctors, leading to poor compliance and impacting sales of their current shots.

Pfizer is ahead in the two-horse race, reporting phase 3 results last year for its candidate, which combines the antigens from its Trumenba and Nimenrix shots. The FDA started a review of the data in December, with a decision due this October.

GSK’s trial, which involved two doses given six months apart to approximately 3,650 participants aged 10-25, will serve a dual purpose as a confirmatory study that should convert Bexsero’s prior accelerated approval to a full license, and as the pivotal study for the five-in-one shot.

In its fourth-quarter results announcement, GSK said it planned to submit its marketing application in the US in the latter half of 2023, suggesting that Pfizer will have a few months' lead if it gets approval on schedule.

Both companies say that the combination vaccines could encourage greater levels of immunisation in young people, helping to protect them from invasive meningococcal disease that is rare, but can be devastating, in some cases killing patients in as little as 24 hours. There are around 1.2 million cases of invasive meningococcal disease each year around the world.

“In the US, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact,” said GSK’s chief medical officer, Tony Wood.

The company has previously said that it thinks the shot could eventually generate $1.1 billion to $2.2 billion in peak sales. Sales of Bexsero and Menveo were around $1.35 billion last year, somewhat inflated by catch-up immunisations delayed by the pandemic.

The head-to-head race mirrors the competition between GSK and Pfizer in respiratory syncytial virus (RSV) vaccines, with the companies both due to hear from the FDA about potential approval of their respective jabs in May.