Meningococcal groups A, B, C, W, and Y vaccine (Pfizer)

Dive Brief:The Food and Drug Administration on Friday approved a new meningococcal vaccine, clearing Pfizers shot Penbraya in teenagers and young adults for protection against the five most common disease-causing serogroups.Penbraya is the first vaccine available that can provide such broad protection, which may make it more convenient than current options. While meningococcal disease is rare, it can be serious and even deadly.Penbraya adds to Pfizers infectious disease portfolio, joining the companys recently approved vaccine for respiratory syncytial virus, or RSV. Yet the company is also adjusting to sharp sales declines for its COVID-19 vaccine and antiviral drug.Dive Insight:Two types of meningococcal vaccines are already available in the U.S. Some protect against serogroups A,C, W and Y, while other shots, like Trumenba, protect against serogroup B.The Centers for Disease Control and Prevention recommends children aged 11 or 12 receive a MenACWY conjugate vaccine, followed by a booster at age 16. People 10 years or older who are at higher risk of meningococcal disease should receive a vaccine against serogroup B, according to the CDC.The multiple shots and spaced-out vaccination regimens leave room for a shot like Penbraya, which is approved for use among people ages 10 through 25.Nearly 9 out of 10 adolescents have incomplete protection against invasive meningococcal disease caused by the leading serogroups, said Jana Shaw, a pediatrics infectious disease specialist at Upstate Golisano Children's Hospital in Syracuse, New York, in a statement provided by Pfizer.Pfizer said the routine use of Penbraya could reduce cases of invasive meningococcal disease as well as deaths and long-term effects from the infection.The FDA approved the shot based on positive results from Phase 2 and Phase 3 trials run by Pfizer.The pharmaceutical giant has continued to focus on its infectious disease business, even as demand for its COVID products has slumped, leading it to cut in revenue forecasts this year by $9 billion.Pfizer expects its RSV vaccine, Abrysvo, to become a major product in the coming years. Initial signs from the shots launch appear promising, company executives have said recently.It is a little bit early to see the dynamics of the RSV market, but it looks like it's a really strong demand right now for RSV vaccines, said Pfizer CEO Albert Bourla at an investment bank conference in late September. Vaccinations are very, very high higher than what we thought it would be.Abrysvo was first approved in older adults earlier this year. In August, the FDA cleared the shot for use protecting newborns via vaccination of their mothers during pregnancy.Pfizer is also testing a combination influenza and COVID vaccine, which the company expects could become a regular option for fall vaccinations in the future.Clearly, combinations are going to unlock a lot of potential because the convenience of getting one shot in one visit, zero co-pay and full protection of respiratory vaccines is very, very compelling proposition, Bourla added. '

LONDON, UK I March 14, 2023 I GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III trial ( NCT04502693 ) evaluating the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years. GSK’s MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo . Invasive meningococcal disease (IMD), a major cause of meningitis and septicaemia, is an uncommon but serious illness that can cause life-threatening complications or even death, typically amongst previously healthy children and adolescents. 1 Among those contracting meningococcal diseases, one in ten will die, sometimes in as little as 24 hours, despite treatment. 2 One-in-five survivors suffers long-term consequences, such as brain damage, amputations, hearing loss and nervous system problems. 1 Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases in most of the world. 3 As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine. Currently, in the US, two separate vaccines needing four injections are required to protect against all five serogroups. This immunisation regimen, coupled with low awareness of the disease, can lead to sub-optimal immunisation coverage rates, particularly for MenB, with an estimated coverage of only approximately 31% of adolescents in the US. 4 Tony Wood, Chief Scientific Officer at GSK, said: “These statistically significant phase III data are a very encouraging step toward reducing the incidence of meningococcal disease. 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. In addition, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation.” GSK is working closely with regulators to review the full phase III data set, including the supplemental Biologics License Application for Bexsero . This clinical trial was both the confirmatory trial for Bexsero and the phase III trial for MenABCWY. Detailed results from this phase III trial will be presented in a peer-reviewed publication and at upcoming scientific meetings. About the MenABCWY phase III trial The trial conducted by GSK is a phase III randomised, controlled, observer-blind, multi-country trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate. It is part of a comprehensive programme to generate clinical evidence on the benefits of meningococcal immunisation. The trial started in August 2020 , and approximately 3,650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia. The objective of the trial was to assess the safety profile of the MenABCWY vaccine candidate and to compare the immune responses of the trial’s participants who received two doses of the MenABCWY vaccine candidate six months apart to the responses of those in the control groups who received GSK’s licensed vaccines, Bexsero (MenB) and Menveo (MenACWY). About Bexsero Bexsero is currently licensed or has received regulatory approval in over 50 countries, including the US and EU, and is used in 12 national immunisation programmes worldwide for the prevention of IMD caused by Neisseria meningitides serogroup B. Bexsero is the only MenB vaccine with trials that have demonstrated a reduction in IMD, including vaccine effectiveness in real-world settings. Regulatory approvals vary by country. It is approved for individuals two months of age and older in Europe. In the US, Bexsero is licensed under the Accelerated Approval pathway for active immunisation to prevent IMD caused by Neisseria meningitides serogroup B in individuals from 10 through 25 years. Approval of Bexsero is based on demonstrating an immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the US. The effectiveness of Bexsero against diverse serogroup B strains has not been confirmed. The US Prescribing Information is available here . About Menveo Menveo vaccine for meningococcal groups A, C, Y, and W has received regulatory approval in over 60 countries, including the US, with more than 72 million doses distributed worldwide since 2010. Menveo offers extensive evidence of immunogenicity with a well-characterised safety profile (consistent with similar vaccines). In the US, Menveo has received regulatory approval for active immunisation to prevent IMD caused by Neisseria meningitides serogroups A, C, Y, and W in individuals from 2 months through 55 years of age. However, Menveo does not prevent N. meningitides serogroup B infections. The US Prescribing Information is available here . About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company References [1] ECDC, Factsheet about meningococcal diseases . Accessed March 2023. [2] Bing Wang et al., “Case fatality rates of invasive meningococcal disease by serogroup and age: A systematic review and meta-analysis”, in Vaccine, Volume 37, Issue 21, 9 May 2019, Pages 2768-2782. Accessed March 2023. [3] CDC. Meningococcal Disease Causes and How It Spreads | CDC . Accessed March 2023. [4] Pingali C, Yankey D, Elam-Evans LD, et al. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2021. MMWR Morb Mortal Wkly Rep 2022; 71:1101–1108. SOURCE: GlaxoSmithKline