World’s first meningitis B national infant vaccination programme shows 75% drop in cases over three years

Two independent meningitis B studies published today in the New England Journal of Medicine demonstrate the real-world impact of GSK’s Bexsero vaccine in reducing disease in infants and underscore the need for individual protection among adolescents.

First: a study from the United Kingdom showed impact data from the first national infant immunisation programme with Bexsero in the world.^[1] According to Public Health England, over a three-year period the total number of meningitis B cases dropped 75 percent. These impact results even included cases caused by strains not predicted to be covered by Bexsero.

Second: results of the largest-ever study of adolescent carriage of meningococcal bacteria, “B Part of It,” showed reduction in number of cases among the trial population in South Australia but no effect on the carriage of bacteria in the nose or throat, a prerequisite of impacting transmission.^[2] This reinforces the need for vaccination of vulnerable individuals, particularly infants and adolescents, in order to help protect against meningococcal disease.

“What both of these important, independent studies with Bexsero indicate is that vaccination provides meaningful protection and reduces cases of this uncommon, but devastating disease,” said Dr. Thomas Breuer, Chief Medical Officer, GSK Vaccines. “Thanks to the UK’s national immunisation programme and the South Australian MenB carriage study, parents and healthcare professionals have real world insight that vaccination makes a difference, in addition to the existing knowledge from clinical trials.”

Starting in September 2015, UK infants have been offered the meningitis B vaccine at two and four months of age, followed by a booster at the age of one year, as part of the routine national immunisation programme.^[3] Public Health England reported the programme resulted in sustained protection lasting at least two years after the final booster at 12 months. This is crucial because the highest burden of MenB disease in England and many other countries is during the first three to five years of life.^[4] GSK will use these data to file a label update.

The results showed an estimated reduction of 277 cases since the beginning of the programme.^[1] But in children who were not eligible for the vaccine, the study showed no decrease in MenB disease.

“England has one of the most comprehensive immunisation programmes in the world. The implementation of the MenB vaccine in 2015 is a great success, it is already saving lives and means fewer parents and young children will experience this devastating illness,” said Dr. Shamez Ladhani, Consultant Epidemiologist for Public Health England. “It is vital that children receive all available vaccines to protect themselves and others. Public Health England is working closely with NHS England to make it as easy as possible for parents to access vaccines so that they can offer their children the best possible start in life.”

In South Australia, more than 34,000 students in their 10^th, 11^th and 12^th year of high school participated in the “B Part of It” large-scale meningitis B vaccination study.^[2] Even though the study did not find vaccination to reduce nasopharyngeal carriage of Neisseria meningitidis, there was a reduction in the number of cases.^[2] After the study, South Australia implemented a meningitis B vaccination programme for both infants and adolescents.

“We know adolescents are more likely to carry meningococcal bacteria in the nasal passage and back of the throat. Although the meningococcal B vaccine is effective in preventing meningococcal B disease, there was no reduction in carriage of the disease-causing strains, suggesting vaccination of the individual provides the best protection rather than relying on herd immunity” said Dr. Helen Marshall, the South Australian study’s investigator.

Advocates hope that the real-world impact of both studies, combined with parental confidence shown by high participation rates (more than 90% of all UK infants got the first two doses and the participation rate of students in South Australia was also high),^[1],[2] will give encouragement to public health authorities around the world.

“This is a disease that has high mortality and profound, life-long effects. These results show that we now have a tool to help prevent it and we hope countries will take the opportunity to do this,” said Linda Glennie, Director of Research at the Meningitis Research Foundation.

Invasive meningococcal B disease develops rapidly, even in previously healthy infants, young children and adolescents. Initial symptoms of meningococcal disease can often resemble flu, making it difficult to diagnose. About one in 10^[5] of those who contract the disease will die, even with appropriate treatment. Additionally, up to 20 percent of those who survive bacterial meningitis may suffer from major physical or neurological disabilities, for example limb loss, hearing loss or seizures.^[5]

Bexsero is currently the only meningococcal B vaccine licensed in Europe for children under 10 years old^[6]; the UK infant immunisation programme is specifically aimed at the prevention of meningitis B.^[7]

About Bexsero

Bexsero is licensed in more than 40 countries^[8]. These countries include the member states of the EU, Argentina, Australia, Chile, Israel, New Zealand, Turkey and Uruguay, where Bexsero is approved for individuals two months of age and older, and in Canada for those aged 2 months to 25 years of age^[9]. In the U.S., Bexsero is approved for use in individuals from 10 years through 25 years of age^[10]. In Brazil, Bexsero is approved for use in individuals from two months to 50 years of age^[11].

Important safety information

In infants and children (less than 2 years of age) the most common local and systemic adverse reactions observed in with Bexsero in clinical trials were tenderness and erythema at the injection site, fever and irritability. In adolescents and adults, the most common local and systemic adverse reactions observed were pain at the injection site, malaise and headache.

Consult the full Prescribing Information/Summary of Product Characteristics for all labelled safety information for Bexsero. Up-to-date information about GSK prescription medicines may be found at http://health.gsk.com.

About GSK

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 www.gsk.com/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.

[1] New England Journal of Medicine. Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England. Jan 23; 382: 309-317. doi: 10.1056/NEJMoa1901229. Epub 2020 Jan 23.

[2] New England Journal of Medicine. Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia. Jan 23; 382:318-327. doi: 10.1056/NEJMoa1900236. Epub 2020 Jan 23.

[3] https://www.gov.uk/government/collections/meningococcal-b-menb-vaccination-programme

[4] European Centres for Disease Control (ECDC). Invasive meningococcal disease – Annual Epidemiological Report for 2017. https://ecdc.europa.eu/sites/portal/files/documents/AER_for_2017-invasive-meningococcal-disease.pdf [Accessed June 2019]

[5] https://www.who.int/en/news-room/fact-sheets/detail/meningococcal-meningitis

[6] Bexsero EU Summary of Product Characteristics, 2019

[7] Lancet. 2016 Dec 3;388(10061):2775-2782. doi: 10.1016/S0140-6736(16)31921-3. Epub 2016 Oct 27

[8] GSK Data on file. 2016N297580_01 31 March 2018

[9] BEXSERO Canada Product Monograph, 2019

[10] BEXSERO US Product Information, 2019

[11] BEXSERO Brazil Product Information, 2019