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From research to implementation - the journey of a new vaccine

Vaccine development takes many years - initial research to final delivery can take up to 30 or 40 years and involves many different bodies including charities like Meningitis Research Foundation, larger funding bodies, national reference laboratories and surveillance, government and the pharmaceutical industry. More than 10 years ago it was estimated that the costs to the pharmaceutical company alone were in the region of $200-400M.

Continuous research is needed throughout the process to make sure that all avenues are explored and that the resulting vaccine is introduced and evaluated as effectively as possible. The cost of developing a vaccine from candidate to commercial launch is beyond the means of charities alone. MRF research has demonstrated the burden of disease and need for a vaccine, identified antigens and developed typing systems and assays crucial in enabling the evaluation of meningitis vaccines but has also leveraged funding from large funding bodies, pharmaceutical companies, and public health laboratories to enable further vaccine development.

Research and surveillance to establish need for a vaccine  This information leads to research into the disease and the bacteria that cause it, better diagnosis and treatment, and vaccine development.
Research to identify vaccine components Research into how the bacteria behave and cause disease will highlight parts of the bacteria that are vital for it to survive or which stimulate our immune system. Research to identify vaccine targets that can be seen by the immune system and are common across different strains is also crucial, and this includes research on the meningococcal genome. These targets are further explored for inclusion in a vaccine.
Research to enable vaccine evaluationThis is particularly important for meningitis vaccines. Meningitis is uncommon enough that true efficacy trials, where you measure disease incidence in vaccinated and un-vaccinated people, are not possible before implementation. To demonstrate efficacy for a disease that normally affects 3 people per 100,000 per year, it would be necessary to vaccinate far too many people. This is why it is so crucial to develop laboratory based methods to show whether vaccinated individuals are protected.
Research to establish burden of diseaseThis includes surveillance to demonstrate disease incidence in different age groups, disease severity, research into the after effects, and finally research to estimate potential cost effectiveness of a vaccine.
Lab-based studies Vaccine components will be tried and tested alone or in combination with others to find the best results. Research using animals helps to show that a vaccine component is functional and is safe for Phase 1 trials in humans.
Phase I clinical trials Researchers test the vaccine in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and find out if there are any side effects.
Phase II clinical trialsThe vaccine is given to a larger group of people (100-300) to see if there is an immune response, whether antibodies in blood from vaccinated volunteers can kill the bacteria, and to further evaluate its safety. These trials also determine the correct dosage.
Phase III clinical trialsThe vaccine is given to large groups of people (1,000 or more) to estimate its effectiveness, monitor side effects, and collect information that will allow it to be used safely.
Pharmaceutical company submits data to licensing agencyIn Europe, all vaccines need a licence from the EMA (European Medicines Agency). Evaluation takes up to 210 days where they consider whether the vaccine meets the necessary quality, safety and efficacy requirements in accordance with EU legislation. These processes ensure that medicines have a positive risk-benefit balance in favour of patients and users of these products once they reach the marketplace.
EMA gives positive opinion The European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP) controls licensing for all medical products for human use. Positive opinion is the precursor to a formal licence being granted.
Licence grantedThe positive opinion is passed to the European Commission which grants the final licence within 60-90 days. The licence sets out which age groups the vaccine should be given to and appoints a recommended dosing schedule. The summary of product characteristics (SPC) and patient leaflet are produced at this point.
Individual country regulatory approval The pharmaceutical company has to apply for marketing authorisation and other regulatory approvals in each country. In the UK this is via the MHRA (Medicines and Healthcare Products Regulatory Agency) and in Ireland it is via the Irish Medicines Board.
JCVI/NIAC starts considering evidenceThe Joint Committee on Vaccinations and Immunisations (JCVI) is an advisory committee for the government in the UK. In Ireland it is the National Immunisation Advisory Committee (NIAC). They consider all data from trials and other research to decide whether the vaccine should be part of the routine immunisation schedule, and for which age groups. The JCVI also uses cost-effectiveness evaluations to decide whether the vaccine should be implemented. These bodies start looking at vaccines early in development and do regular “horizon scanning” to highlight vaccines likely to be available within the subsequent five years.
 JCVI/NIAC recommendationOnce the advisory bodies have given a positive recommendation, the process of securing the vaccine and arranging implementation can begin.
Treasury negotiationsA period of negotiation with the treasury ensues to get the vaccination programme funded.
Logistical negotiationsLogistical issues to enable the vaccine to be rolled out are agreed. The process varies according to whether it is to be given in GP surgeries, or in schools or other settings.
Vaccine introducedImmunisation begins in identified age groups and public campaigns continue to make sure uptake is high.
Post-marketing surveillanceThis includes phase IV clinical trials and pharmacovigilance to monitor risks, benefits, and optimal use over a longer period.
Research to enable vaccine implementation and evaluate impactOngoing research looks in detail at how to monitor the impact of the vaccine once introduced, how well it is working, and whether there are any improvements that can be made.