How we develop new vaccines
We invest in scientific and technical excellence to develop and launch a pipeline of new vaccines that meet the needs of patients and payers.
Our work to research, develop and introduce a new vaccine typically goes through several stages:
Discovery – using the isolated pathogen to develop a possible vaccine
Every disease has different characteristics, so each vaccine will have an individual development path. Depending on the disease in question, pathogens can either be reduced in potency or completely inactivated. This makes them safe for use in the vaccine. In some cases, components of the pathogens can be purified and combined. The addition of specialised molecules - known as adjuvants - can then promote the body’s immune response.
Pre-clinical testing – understanding how the potential vaccine works, and how it is likely to affect the body
Before any testing in humans, a new vaccine will undergo careful investigation in the laboratory, followed by trials in animals. The potential vaccine will be checked to ensure any purification has not altered its identity, and that it stimulates the appropriate immune response. The effects of adding any adjuvant system will also be evaluated. Animal trials follow strict guidelines laid down by the regulatory authorities, and will only be carried out when questions cannot be answered with another method.
Clinical trials – carrying out tests in humans
Testing in humans is conducted in three phases, all governed by internationally agreed principles. In Phase I, studies on small groups of volunteers evaluate safety, immune effect and tolerance to different doses. Phase II involves a larger group and confirms formulations and doses, and identifies the need for boosters and the best intervals between each dose. Phase III will evaluate the protection given to several thousand volunteers who are at risk from the disease in question. Clinical trials can take many years.
Regulatory approval – submitting data and information to regulators to gain approval for vaccines
All the information and data collected during development and trials of a new vaccine are presented to relevant regulators at regional level (where appropriate, for example in the EU), and national level. Before authorisation is granted, all questions raised by the regulators must be fully answered which ensures consistency of standards.
Supplying, manufacturing and shipping – delivering vaccines to those who need them
Like the development of vaccines, manufacturing is highly complex and takes time. One specific challenge is that supply meets demand, which will often mean the new vaccine needs to be produced in large quantities. Different facilities are required to make each new vaccine, and plans will be prepared to have these ready to start production as soon as regulatory approval is granted. Demand forecasting is an essential element of providing sufficient quantities of vaccines, and GSK are working closely with the relevant authorities to improve the accuracy of demand forecasts.
Monitoring – evaluating vaccines after introduction
Once a vaccine has been introduced to the market, it continues to be closely monitored at different levels. This ensures that the experience gathered from its use in large numbers of the population is captured, and its ongoing safety and effectiveness are closely assessed. In many cases, such long-term monitoring will be a condition imposed by the regulatory authorities and can also lead to an updated assessment of the use of the vaccine demonstrating that it might have wider uses than first appreciated.
There are more than 30 GSK vaccines available around the world, and every individual vaccine has been through the same rigorous process before being introduced into markets. Our vaccines have helped save many lives, and their continued effectiveness is a testament to the dedication and the many long hours, days, weeks, and years that our scientists spent in the lab developing them.
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