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2013 MeDiciNes iN DeVelopmeNT REPORT Vaccines A Report on the Prevention and Treatment of Disease Through Vaccines PRESENTED BY AMERICA’s biopharmACEUTICAL RESEARCH COMPANIES Nearly 300 Vaccines Are in Development; Research Focuses on Prevention and Treatment For many years, vaccines have been used • A monoclonal antibody vaccine that to successfully prevent devastating infec- targets both pandemic and seasonal tious diseases such as smallpox, measles influenza. and polio. According to data from the • A genetically-modified vaccine designed Vaccines in Development* U.S. Centers for Disease Control and for the treatment of pancreatic cancer. Prevention (CDC), 10 infectious diseases Application Submitted have been at least 90 percent eradicated • An irradiated vaccine for protection in the United States thanks to vaccines. Phase III against malaria. This has protected millions of children Phase II and families from needless illness. The development and regulatory path that these vaccine candidates face is Phase I These public health triumphs illustrate the complex. As with the development of all major contributions that vaccines have drugs, the majority of vaccines must pre- 137 made in saving countless lives around vail through years of clinical testing before the world. In the past several years, they can be approved for use by the gen- through our growing understanding of eral public. However, advances in other the molecular underpinnings of disease scientific fields, such as genomics and and technological advances, many new manufacturing technologies, are becom- vaccines have been developed, including ing increasingly useful in the development one against human papillomavirus (HPV) of new vaccines. The continued efforts 99 infections that can lead to cervical cancer, of researchers within biopharmaceutical a vaccine to guard against the anthrax companies and across the ecosystem, virus before exposure, and a vaccine to who are pursuing new techniques and prevent pneumococcal infections in high- strategies in vaccine development, cre- risk populations. ate tremendous opportunities to protect against many more life-threatening But vaccines are not only for preventing diseases in the future. infectious diseases, some help the body fight a range of illnesses by activating the immune system to recognize and at- contents tack disease. In 2010, a new cancer vac- Innovative Vaccines in the Pipeline .................2 cine for the treatment of prostate cancer Preventative Vaccines: Positive Impact ...........3 was approved in the United States, and many more immunotherapeutic vaccines Scientific Advances in Vaccine Development .... 4 are in development. Vaccine Successes in the United States ........6 15 13 Vaccines in Development .......................... 10 10 Today, biopharmaceutical research com- Glossary ...................................................33 panies are developing 271 vaccines for Drug Development/Approval Process ........36 infectious diseases, cancer, neurological s gy er disorders, allergies and other diseases. der Other Aller Canc ectious ological Among the projects in development are: Disor Inf Diseases Neur • A therapeutic vaccine for HIV infection *Some vaccines are listed in more than one category. intended to delay disease progression. Key Issues innovative Vaccines in the Pipeline of the parasite is enough to cause an immune response, but not cause the disease, thus leading to protection against any Building on the transformational successes to date, the future malarial bite infection. future of vaccines—both for the prevention and treatment of disease—offers great hope for improving and preserving c ervical cancer—A live, attenuated Listeria monocyto- public health in the United States and across the globe. The genes (LM)-based immunotherapy is in development for 271 medicines in development span a wide array of diseases, the treatment of women who already have cervical cancer and employ exciting new scientific and technical knowledge. as a result of infection by the human papillomavirus (HPV). Here are a few examples of the promising vaccines in the The vaccine targets the HPV gene E7, which is responsible pipeline: for the transformation of HPV-infected cells into dysplastic or malignant tissue. The vaccine is engineered to secrete a Malaria—A malaria vaccine in development has shown to fusion protein that instructs the body’s immune system to be 100 percent effective in early clinical trials in preventing destroy the tumors. the transmission of the disease from infected mosquitoes to humans. The vaccine builds on initial knowledge gained in HIV Infection—A therapeutic vaccine in development is tar- the 1970s, where researchers demonstrated that long-term geting the low-mutating (conserved) parts from the protein protection against malaria was possible when volunteers p24 of the HIV virus. The vaccine consists of four peptides received thousands of bites from radiated infected mosqui- that are modified to increase the immune response against toes. The vaccine in development uses a weakened form of the conserved parts of the p24 protein. A sustained immune the whole sporozoite, a life-stage of the parasite Plasmo- response against the p24 protein has shown to be associ- dium falciparnum that causes malaria. This weakened form ated with delayed disease progression. Milestones in Vaccine Development 2013 egg-free vaccine first therapeutic 2010 cancer vaccine (U.S.) 2007 avian flu vaccine 2003 nasal flu vaccine hepatitis B vaccine 1981 polio vaccine 1952 rabies vaccine 1885 first vaccine ever developed is for smallpox 1796 2 Medicines in Development Vaccines 2013 Key Issues influenza—A monoclonal antibody (mAb) vaccine in and is a fully synthetic nanoparticle vaccine engineered to development targets both pandemic and severe seasonal mimic the properties of natural pathogens to elicit an im- influenza A virus infections. The mAb vaccine, made from mune response. recombinant human antibodies from human B-cell cultures, specifically targets the M2 protein of the virus, which is es- sential for the influenza virus to function normally. “More than two-thirds of new vaccines developed in the last 25 years have been Pancreatic cancer–A potential treatment for pancreatic developed from the United States.” cancer is a combination of two therapeutic vaccines. The Source: PhRMA 2013 Vaccine Fact Book treatment combines a Listeria-based vaccine that has been engineered to express the tumor-associated antigen mesothelin and allogeneic pancreatic cancer cells that are Preventative Vaccines: genetically-modified to secrete the immune-stimulant, Positive impact to Health and society granulocyte-macrophage colony stimulating factor (GM-CSF). The cells are irradiated to prevent further cell growth Vaccines are one of the most profound achievements of bio- although they stay metabolically active. Sequential adminis- medical science and public health. Spanning more than 200 tration of the vaccines in animal studies have demonstrated years of research and development, 10 infectious diseases enhanced tumor-specific T-cell and anti-tumor responses. have been at least 90 percent eradicated in the United States thanks to vaccines. This has protected millions of children s moking cessation–One in a new class of targeted vac- and families from avoidable illness. cines in development induces an antigen-specific immune activation for smoking cessation and relapse prevention. The prevention of disease has an enormous impact on the It is made from biocompatible and biodegradable materials health of individuals, but also the health of communities and RESEARCH & HOPE AWARDS On September 11, 2013, PhRMA, along with distinguished members of the medical, patient, and provider communities, presented the second annual Research & Hope Awards. This year’s program highlighted the history, progress and promising future of vaccines and immunization. PhRMA proudly presented the following awards: T he Research & Hope Award for Academic or Public Research in Vaccine Development Presented to individuals or a team from academic or government institutions for outstanding research in the area of vaccine development. 2013 award presented to: Douglas R. Lowy, M.D., and John T. Schiller, Ph.D., National Cancer Institute T he Research & Hope Award for Biopharmaceutical Industry Research in Vaccine Development Presented to individuals or team from a biopharmaceutical company for outstanding research in the area of vaccine development. 2013 award presented to: GlaxoSmithKline Malaria Vaccine Team T he Research & Hope Award for Patient and Community Health Presented to an individual or organization that has had a significant impact educating parents, health care providers or students about the importance of childhood immunizations and facilitating increased vaccinations in their community. 2013 award presented to: Linda Y. Fu, M.D., Children’s National Medical Center To learn more about the dedicated researchers honored with the 2013 Research & Hope Awards, please visit www.phrma.org/awards. Medicines in Development Vaccines 2013 3 Key Issues economies by reducing health care costs and avoiding lost pro- Today, there are 204 active clinical trials for vaccines, in- ductivity. Preventative vaccines are given to individuals, but see cluding 107 that have not yet started recruiting patients or their greatest benefit when entire populations are immunized. are just now seeking volunteers to participate and another When a high level of vaccination is achieved
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