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Infants may now be protected against Meningitis B with fewer doses, adding flexibility to vaccination schedules

New, alternative 2+1 dosing schedule approved in Europe for Bexsero in infants

Issued: London, UK

Healthcare professionals now have more options to help protect infants from invasive meningococcal disease (IMD) caused by serogroup B, after European Commission approval 
of an alternative Bexsero (rDNA, component, adsorbed)1 immunisation schedule requiring one less injection.

The reduced immunisation schedule for infants: two primary doses of Bexsero plus one booster dose, triggers a similar immune response as the existing 3+1 schedule.

The EMA approval of this new option allows health care professionals and public health officials to continue using the existing 3+1 schedule or alternatively begin Bexsero vaccinations at 3 months of age with a minimum interval of 2 months between the first and second dose.

For parents, the flexibility could mean fewer visits to the doctor’s office.

“Reducing the doses required to complete the course from four to three, with similar immune response, lowers costs and is easier on babies,” said Dr. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines.  “Depending on local epidemiology or recommendations, the additional 2+1 schedule for Bexsero provides more options to complete a course of vaccination to help protect against MenB infection.”

EMA approval for the 2+1 schedule was based on data from a previously reported study which evaluated different dosing schedules in healthy infants starting at 3 months of age.2 

“The reduced number of doses during the first year of life could increase compliance and may improve vaccination timing with more children up to date with their vaccination schedule,” said Dr. Federico Martinon-Torres, Head of Pediatrics at Hospital Clínico Universitario de Santiago and lead author of the study.

Invasive meningococcal disease (IMD) is an uncommon, yet serious and unpredictable disease that can kill in as few as 24 hours.3 4 5  Infants and children under 5 years are most vulnerable to IMD due to serogroup B.

About meningococcal B disease

Invasive meningococcal B disease (commonly known as MenB) is the leading cause of life-threatening meningitis in most of the industrialised world. Although rare, invasive meningococcal B disease develops rapidly, typically amongst previously healthy children and adolescents, and results in high morbidity and mortality. Initial symptoms can often resemble flu, making it difficult to diagnose. About one in 10 of those who contract the disease will die, even with appropriate treatment. Additionally, around 10 percent of those who survive the disease may suffer a major physical or neurological disability (limb loss, hearing loss or seizures).6 7 

About Bexsero

Bexsero is licensed in more than 40 countries8  including the U.S. These countries include the member states of the EU, Argentina, Australia, Chile, Israel and Uruguay, where Bexsero is approved for individuals two months of age and older, and in Canada for those aged 2 months to 17 years of age. In the U.S., Bexsero is approved for use in individuals from 10 years through 25 years of age. In Brazil, Bexsero is approved for use in individuals from two months to 50 years of age.

Important safety information

The most commonly reported side effects by those who received Bexsero were pain and swelling at the injection site, headache, diarrhoea, muscle pain, joint pain, fatigue, and chills.

Reactions seen following vaccination with Bexsero in clinical trials were comparable to those following other routine vaccines. The most common adverse reactions (more than 1 in 10 people) reported in all age groups 2 months to 17 years of age are pain/tenderness at the injection site, redness at the injection site, swelling at the injection site, and hardness at the injection site.1 

GSK - a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit https://www.gsk.com/en-gb/about-us/ 

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2017.

References

1. Bexsero Summary of Product Characteristics June 2018. https://www.medicines.org.uk/emc/medicine/28407

2. Martinón-Torres F, Safadi MAP, Martinez AC, et al. Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: immunogenicity and safety results from a randomised open-label phase 3b trial. Vaccine. 2017;35(28):3548-3557.

3. Pelton SI. Meningococcal Disease Awareness: Clinical and Epidemiological Factors Affecting Prevention and Management in Adolescents. J Adolescent Health. 2010;46:S9-S15.

4. Rosenstein NE, Perkins BA, Stephens DS, et al. Meningococcal Disease. New England Journal of Medicine. 2001;344(18):1378–1388.

5. Thompson MJ, Ninis N, Perera R, et al. Clinical Recognition of Meningococcal Disease in Children and Adolescents. Lancet. 2006;367(9508):397–403.

6. World Health Organization (WHO). Meningococcal Meningitis Fact Sheet. www.who.int/mediacentre/factsheets/fs141/en. Updated January 2018. Accessed March 2018..

7. Viner RM, et al. Outcomes of invasive meningococcal serogroup B disease in children and adolescents (MOSAIC): a case-control study. Lancet Neurol. 2012;11(9):774-783.

8. GSK Data on file. 2016N297580_01 04 May 2018.