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With positive combo meningococcal vaccine data, GSK eyes US approval, Health News, ET HealthWorld

London: GSK on Tuesday said that late-stage data showed its experimental combination meningococcal vaccine was as effective as two of its existing vaccines that target different strains of the bacteria behind the sometimes life-threatening infections.

If approved, the combo vaccine could simplify the immunization schedule in the United States and likely expand GSK’s already dominant market share there for vaccines used to prevent illnesses caused by meningococcal bacteria. The bacterial infection can lead to severe, and sometimes fatal, bloodstream infections as well as severe swelling in the brain and spinal cord.

The trial, which involved about 3,650 participants aged 10 to 25, evaluated the immune responses from two doses of the combo vaccine, called MenABCWY, given six months apart. These responses were compared to participants who received GSK’s approved vaccines, Bexsero and Menveo.

In the United States, a four-shot regimen of Bexsero and Menveo is needed to protect against the five most common strains of meningococcal bacteria. The high number of doses, plus low awareness of the disease, are factors behind low immunization rates, GSK said in its press release announcing the data.

There is no combination vaccine on the market – a gap GSK intends to fill with the new combination. The company hopes to file for US approval later this year.

“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 Tony WoodGSK’s scientific chief officer, in a statement on Tuesday.

Last year, GSK’s meningitis vaccines generated around 1.1 billion pounds in combined sales across the dozens of countries they are already approved in.

The MenABCWY positive readout comes as the British drugmaker’s vaccine portfolio is expected to get a big boost from the expected launch of its respiratory syncytial virus (RSV) vaccine in the US later this year.

The blockbuster potential of the RSV vaccine has generated considerable investor enthusiasm, even amid concerns that the drugmaker could struggle to sustain growth through the end of this decade given key patent expiries and forecast declining revenues for some of its current bestsellers.

GSK has the world’s largest vaccine R&D department and has a broad portfolio of shots, including its blockbuster shingles vaccine Shingrix. Its vaccines business brought in 7.9 billion pounds ($9.61 billion) in sales last year. ($1 = 0.8222 pounds) (Reporting by Maggie Fick Additional reporting by Natalie Grover Editing by Christina Fincher)

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