GSK chases down Pfizer in 5-in-1 meningitis jab contest

Armed with new data, GSK is preparing to file for approval of its new-generation meningitis vaccine, as it tries to maintain its leadership in the category against a challenge from Pfizer.

Preliminary results from a phase 3 study of the MenABCWY vaccine – which covers all five meningococcal strains in one go as an alternative to separate vaccinations – showed that it was at least as effective as vaccination with GSK’s current MenB jab Bexsero and Menveo for MenACWY given separately.

Endpoints in the study included antibody titres against the various meningococcal strains, and the ability for sera taken from subject to kill Neisseria meningitidis bacteria in the lab. The data was presented at the European Society for Paediatric Infectious Diseases (ESPID) congress in Lisbon, Portugal.

The trial involved subjects aged 10 to 25 who received the vaccine as two doses given six months apart, and also found that the shot was generally well tolerated, with a safety profile consistent with Bexsero and Menveo.

GSK’s chief scientific officer, Tony Wood, said that the results show the vaccine protects against “the broadest panel of circulating MenB strains to date,” adding that MenB is “the most common cause of meningococcal disease in the US, with the lowest immunisation rate.”

The drugmaker said it is now “working closely” with regulatory agencies to look at the data and prepare filings, without giving a timeline for that to happen. At the same time, the results from the trial will be used as a confirmatory study to seek a full license for Bexsero, which was given accelerated approval by the FDA in 2015.

In the meantime, however, GSK is lagging behind Pfizer, which filed for approval of its five-in-one meningococcal vaccine for the same target age group last December and is expecting to hear back from the FDA in October.

Pfizer’s vaccine combines its Nimenrix for MenB and Trumenba for MenACWY, showing equivalence to the separate shots in phase 3 results reported last year.

Both companies see potential for their new vaccines in simplifying immunisation schedules and reducing the number of injections needed, 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 low sales.

That hasn’t stopped Bexsero’s steady growth, with sales approaching the $1 billion threshold last year, while Menveo added another $430 million.

Pfizer has been something of an also-ran in the market to date, with Nirmenrix making $193 million last year and Trumenba revenues not large enough to be broken out in its financial reporting. It is hoping to make up the ground with the new vaccine, if approved.

GSK’s strong position in the category could be in its favour, however, and particularly the dominance of Bexsero, which has been something of a pathfinder shot for MenB around the world. The company has previously suggested that the 5-in-1 vaccine could eventually become a $1 billion to $2 billion product.