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What are the challenges in developing new vaccines?

Despite decades of vaccine development there is currently only licensed vaccines for 26 infectious diseases
Challenges In Developing New Vaccines Expense And Time
© BSAC

Vaccines have a major role to play in public health. However, despite decades of vaccine development there is currently only licensed vaccines for 26 infectious diseases.

These are listed in the table below:

Cholera Mumps
Dengue Pertussis
Diphtheria Pneumococcal disease
Hepatitis A Poliomyelitis
Hepatitis B Rabies
Hepatitis E Rotavirus
Haemophilus influenzae type b (Hib) Rubella
Human papillomavirus (HPV) Tetanus
Influenza Tick-borne encephalitis
Japanese encephalitis Tuberculosis
Malaria Typhoid
Measles Varicella
Meningococcal meningitis Yellow Fever

Table adapted from WHO

Why vaccine development is difficult

Vaccine development is expensive and time consuming. New vaccines are initially tested in animal studies and only if they show promising results do studies or clinical trials begin in humans.

Clinical trials move through three phases, each with increasing numbers of participants. At each stage if a vaccine is unsafe, or shown not to work, then development is halted.

An infographic showing the 3 different stages of how a vaccine is developed, approved and manufactured. It shows the different phases and the questions that would be asked at each stage

Image sourced from Centers for Disease Control and Prevention. A text version of the above image is available as a PDF.

Case study: vaccine for Plasmodium falciparum malaria

The pharmaceutical company GSK has spent more than 30 years developing its vaccine RTS,S (Mosquirix) against the parasitic infection Plasmodium falciparum, which causes malaria.

Currently this vaccine is undergoing assessment in phase 4 studies in Africa to provide further data on vaccine safety and efficacy. The illustration below highlights the decades spent developing this vaccine, the cost of which is estimated to be more than $800 million by the completion of Phase 4 trials.

Timeline for development of RTS,S beginning at 1984 and ending at 2015. For each significant development the date is shown with a sentence explaining what happened

Click to enlarge

Image sourced from Kaslow, D. and Biernaux, S., 2015. This is available as a PDF.

© BSAC
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