At Pfizer, we believe in the promise and value of vaccines to improve people's lives. Leveraging leading technology in vaccine design and conjugation, we are pursuing preventative solutions to complex, difficult-to-treat bacterial pathogens — across the lifespan. We are also exploring the power of novel therapeutic vaccines to treat chronic conditions, and diseases such as cancer.
Trumenba® is the first vaccine approved in the United States to protect against meningococcal meningitis serogroup B, and we are in the process of filing with regulatory authorities in other countries around the world.
During 2015, we acquired from GlaxoSmithKline two quadrivalent (ACWY) meningitis vaccines, Nimenrix® (meningococcal serogroups A, C, W-135 and Y conjugate vaccine) and Mencevax® (meningococcal polysaccharide serogroups A, C, Y and W-135 vaccine), currently marketed in a number of countries outside the U.S. In 2014, we acquired NeisVac-C® (meningococcal group C-TT conjugate vaccine, adsorbed) from Baxter, a vaccine for protection against serogroup C meningococcal disease, marketed primarily in Europe. With the addition of these complementary vaccines, we have created a comprehensive portfolio that is focused on helping to prevent meningococcal disease and for controlling outbreaks.
In Trumenba's first year of availability, we have already helped respond to outbreaks of serogroup B meningococcal meningitis at colleges and universities within the U.S. Following a public announcement by the Rhode Island State Department of Health that two students at Providence College contracted the disease, Pfizer worked with the college's officials to supply the vaccine for the on-campus vaccination clinic. We delivered the doses in less than a day and supported more than fifty health care providers who administered them. At the University of Oregon, when four students were confirmed to have contracted the disease, it took us only one day to put together a unique partnership with two local pharmacy chains to ultimately supply mass vaccination events targeting more than 22,000 students.
Our Prevnar franchise (known as Prevenar outside the U.S.) continues to expand. We recently manufactured our billionth dose. And with Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) we are reaching more people, at more stages of life, around the world.
In 2014, the U.S. Centers for Disease Control and Prevention recommended Prevnar 13 for routine use to help protect adults age 65 and over against pneumococcal disease. Additional adult recommendations are under consideration by health authorities in countries around the world. We continue to work in close collaboration with global partners, such as the International Federation on Ageing, to raise awareness of the importance of adult vaccination.
We have pledged to supply up to 740 million doses of Prevenar 13® (pneumococcal polysaccharide conjugate vaccine, 13-valent, adsorbed) through 2025 to infants and young children throughout the developing world at a non-commercial price, through Gavi, the Vaccine Alliance.
To help address the practical constraints experienced by health workers operating in many Gavi countries, Pfizer has developed Prevenar 13® in a multi-dose vial (MDV) presentation and added the preservative 2 phenoxy ethanol to reduce vaccine wastage. The MDV presentation will contain four doses of Prevenar 13, and will be the same size as the current single dose vial. This will result in a smaller environmental footprint with a 75 percent reduction in cold chain and shipping material requirements. The dossier for the new MDV presentation is subject to approval by the European Medicines Agency and WHO prequalification. Pfizer's ongoing investments to ensure high quality vaccines in adequate and reliable supply, as well as the first preserved PCV multi-dose vial presentation, will help ensure more children have access in communities whose health care systems are still developing.
We have two prophylactic vaccines for hospital-acquired infections in Phase 2 trials, one to help prevent Clostridium difficile (C. difficile) disease and one to help prevent Staphylococcus aureus (S. aureus) infections. Both of these investigational vaccines have been granted Fast Track status by the U.S. Food and Drug Administration.
C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. Pfizer is currently investigating a vaccine that targets the two main disease-causing toxins produced by C. difficile (Toxin A & B) and initiated a Phase 2 clinical trial to investigate the safety, immunogenicity and tolerability of Pfizer's C. difficile vaccine in healthy older adults.
S. aureus infections persist as a major cause of life-threatening hospital-acquired infections. To date, there is no licensed vaccine available to prevent invasive S. aureus disease. Our new investigational, multiantigen S. aureus vaccine is uniquely designed to help prevent a wide range of clinical disease manifestations by potentially facilitating pathogen killing at early stages of invasive infection.
To deliver on our promise to bring immunizations to people across all stages of life, we are exploring the development of maternal vaccination candidates to protect newborns from dangerous infections such as Group B streptococcus, respiratory syncytial virus, and cytomegalovirus (CMV), a herpes virus. Our acquisition of Redvax GmbH, a spin-off from Redbiotec AG, a privately held Swiss biopharmaceutical company, provides access to a preclinical human cytomegalovirus vaccine candidate, as well as intellectual property and a technology platform related to another vaccine program. The CMV vaccine program will complement our robust research portfolio of investigational vaccines and help place Pfizer among the leaders in CMV research and development.
The Institute of Medicine has ranked the development of a CMV vaccine as the highest priority because of the lives it would save and the disabilities it would prevent. A large segment of young adults, especially women of childbearing age who remain CMV negative, are at high risk of CMV infection during pregnancy and of passing the infection on to the unborn child (congenital infection). There are potentially serious and lifelong consequences for babies born with the disease. More children have disabilities due to congenital CMV than other well-known infections and syndromes, including Down syndrome, fetal alcohol syndrome, spina bifida and pediatric HIV/AIDS.
The Value of Vaccines
The Impact of Vaccines on Infectious Disease Morbidity in the United States, Pre-vaccines – 2014