How are vaccines researched and developed?

Finding a new vaccine begins with understanding the structure of the virus or bacterium and how it causes the infection which are you are trying to prevent. Vaccines contain a harmless form of the bacteria or virus that causes the disease.

This means the bacteria or virus will be killed, greatly weakened, or broken down into small parts before being used to trigger an immune response in the person receiving the vaccine but without making them ill.

Carefully working out how to do this and selecting appropriate technologies happens in pre-clinical testing. It is then a case of thoroughly testing a vaccine through clinical trials to make sure it’s effective and safe to use.

Historically, developing a new vaccine has required:

Sustained investment and effective introduction of new technologies are essential to enable vaccine-preventable diseases to be controlled, eliminated and potentially eradicated.

By using advances in genetic sequencing for the viruses and bacteria that cause diseases, companies have managed to speed up vaccine R&D.

New technologies like artificial intelligence are helping to make the development of vaccines quicker.

Where similar diseases have appeared around the world, the research can increasingly be translated into research for vaccines against similar strains.

Developing vaccines takes deep scientific knowledge and expertise. Pharmaceutical companies need to make decisions about what research they’re going to invest in and generally look at four questions:

What value will it provided patients? They need to make sure the new vaccine establishes a new standard of care which has the potential to significantly extend and improve patient lives.

What value will be provided to health care systems? They aim to reduce the costs associated with hospitalisation and other costly complications of disease if not appropriately (or optimally) treated.

What is the unmet need? They need to make sure any new vaccine addresses a critically unmet medical need, where few or no treatments exists.

What is the R&D sustainability? What will continued investment in risky and capital-intensive R&D come up with, and is this a sufficiently important breakthrough?

When the global community works together, we can dramatically advance the development and delivery of vaccines. The pharmaceutical industry and the public sector, academia and non-governmental organisations have a long history of working together to research vaccines and to develop and manufacture them at scale.

The UK has a thriving ecosystem of public-private collaborations helping to push back the boundaries of science and find new vaccines.

ABPI member companies are working with the UK Vaccine Network on vaccines and technologies for infectious diseases with the potential to cause an epidemic.⁸

Vaccine development stats

• +10 years of R&D for each successful vaccine[1]
• 12-18 months for first regulatory approval[2]
• 24 months to manufacture[3]
• 70% of production dedicated to quality control¹
• 6% probability of market entry from preclinical¹
• £374 million-£1.5 billion GBP cost of development[4]
• £485 million cost of building a biological manufacturing site¹

Page references

[1] IFPMA. Innovation for a healthier world 2015. Accessible at: https://www.ifpma.org/resource-centre/innovation-for-a-healthier-world-how-the-research-based-vaccine-manufacturers-are-contributing-to-the-decade-of-vaccines-action-plan/ Last accessed April 2020. Values converted from USD at prevailing exchange rate on 8/4/20

[2] Vaccines Europe. The EU vaccine industry in Figures. 2015. Available at: https://www.vaccineseurope.eu/about-vaccines/vaccines-europe-in-figures/ Last accessed June 2018

[3] Plotkin S et al. The complexity of vaccine manufacturing - an overview. Vaccine 2017;35;4064-4071

[4] O’Neill J. Vaccines and alternative approaches; reducing our dependence on antimicrobials. February 2016. Available at: https://amr-review.org/sites/default/files/Vaccines%20and%20alternatives_v4_LR.pdf Last accessed June 2018