GSK trails after Pfizer in 5-in-1 meningococcal vaccine race

The FDA has started a review of GSK’s five-in-one meningococcal vaccine, cueing up a decision in mid-February next year, as it tries to chase down a rival candidate from Pfizer cleared last year.

The new vaccine is a combination of GSK’s already-approved vaccines Bexsero and Menveo and is designed to protect against meningitis and blood poisoning caused by the A, B, C, W, and Y serogroups (MenABCWY) of the bacteria Neisseria meningitidis.

MenABCWY covers five of the six serogroups that cause most disease worldwide, with the B, C, and Y strains responsible for most cases of invasive meningococcal disease (IMD) encountered in the US.

GSK is currently the market leader in the meningococcal vaccine market, racking up sales of £1.26 billion (almost $1.6 billion) last year across the Bexsero and Menveo brands, but is having to play catch-up to Pfizer in the MenABCWY combination category after the FDA cleared the latter’s Penbraya in October.

Penbraya also combines elements from Pfizer’s meningococcal vaccines Trumenba and Nimenrix, which together made around $300 million in 2023, and was due to start shipping in the US at the start of this month.

Also active in the category is Sanofi, which sells MenACWY vaccines Menactra and MenQuadfi, lacking coverage of the B serogroup considered the most common cause of meningococcal disease in the US. Sanofi is working on a MenABCWY shot codenamed SP0230 which is currently in mid-stage clinical development.

The companies see potential for their new vaccines in simplifying immunisation schedules and reducing the number of injections needed – four across two products before Penbraya’s launch – as well as potentially enhancing uptake and reducing costs.

They argue that the current need to use multiple meningococcal vaccines to provide coverage across all meningococcal strains has resulted in confusion among consumers and doctors, leading to poor compliance and restricting sales.

In the US, while meningococcal vaccine recommendations for all five serogroups have been in place since 2015, annual immunisation rates for IMD have remained low overall.

With the FDA review now underway, GSK is hoping for a positive verdict for its shot by the action date of 14th February.

“IMD is an unpredictable but serious illness that can cause life-threatening complications,” said GSK in a statement. “Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours. One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss and nervous system problems.”