Eu Paediatric Medicines Regulation

Attitudes towards vaccination are changing, as the promise grows of candidate products in development which have the potential to prevent and treat some of the major diseases affecting the world's population today.

Immunisation, the World Health Organization argues, has proved itself: smallpox was eradicated worldwide in the late 1970s, Europe was declared free of polio at the turn of the 21st century and, in 2002 alone, an estimated two million lives were saved by immunisation. Years of disappointment, with vaccines for unmet needs failing in Phases II and III, are ending as new vaccines begin to reach the market and more advance through the pipeline.

In 2007, pre-teenage and teenage girls are being vaccinated against HPV, a known and common cause of cervical cancer, the second-largest cancer killer of women. In the next few years, approval is expected for vaccinations against other forms of cancer, including prostate, colon and lung cancers.

There are also advanced candidates for influenza, malaria, tuberculosis, hepatitis B and HIV. Vaccines for rotavirus and meningitis A, diseases that kill vast numbers of children in the developing world each year, may not be far off and their development is being supported by public and private funding, in addition to fast-tracking rulings. Innovation by small biotechnology companies, financially and commercially supported by strategic alliances with the largest pharmaceutical companies, has led to the development of the therapeutic vaccine, which has the potential to treat rather than prevent disease and has given new hope to the sufferers of cancer, CNS disorders, autoimmune conditions and asthma, even addiction.

The largest section of the vaccination market is paediatric immunisation. Six vaccines are routinely given to children as part of their infant immunisation - these comprise vaccines against tuberculosis (BCG), diphtheria, tetanus, pertussis, polio (OPV) and measles. However, not all children receive these immunisations and in some developed countries the number of children being vaccinated is dropping. These problems must be redressed in order to prevent the 30,000 deaths which are estimated to take place each day from entirely vaccine-preventable diseases. Other, newer vaccines are also available and need to be more widely used, including vaccines against yellow fever, rubella, hepatitis B, Haemophilus influenzae type B (Hib) disease and Japanese encephalitis.

Adult vaccination is on the increase and now growing at a faster pace than paediatric immunisations. This is largely because of the recent emphasis placed on immunisation against influenza and hepatitis. Children will benefit from the development of new combination products while everyone will reap the benefits of alternative routes of delivery to needles.

Traditionally, vaccines have been given to people who are healthy and, therefore, it is easy to forget what it was like before mass immunisation programmes began. This also means that in the unfortunate instances when individuals suffer side-effects, this can overshadow the many deaths that are prevented; just a rumour can halt the development of a promising product. New vaccines have to be proven and then proven again to be safe, leading to long clinical trials and, as a result, extreme expense and delay.

This is just one of the hurdles that vaccine developers have to overcome in order for a new product to reach the market. However, vaccine R&D departments are receiving more funding than ever, which should not only mean more vaccines reaching more people, but also a change in attitude amongst the pharmaceutical industry towards vaccines and, therefore, greater investment in development.

This report examines the latest developments in the vaccine industry with particular emphasis placed on the role of vaccines in the prevention and treatment of cancer. It includes an overview of the immune system, an outline of how immunisation works and an assessment of how different types of vaccine work with that system. The report looks in particular at the suitability of cancer as a target for the next generation of vaccines (Chapter 1).

The report examines the size and value of the vaccine market as it is today (Chapter 2). This includes a full discussion of the vaccines that have reached the marketplace, including the first cancer vaccines. The vaccine market is currently dominated by a handful of pharmaceutical companies and these are also discussed.

The vaccines industry faces numerous opportunities as its understanding of the immune system grows, increasing both the number of vaccines in development and the range of suitable indications to target. However, there are also serious challenges that must be overcome (Chapter 3).

The report includes a full discussion of the many vaccines currently in development, focusing on those for cancer and for other unmet needs (Chapter 4). The report concludes with brief profiles of the pharmaceutical and biotechnology companies that are actively developing cancer vaccines (Chapter 5).