| 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 evaluation | This 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 disease | This 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 trials | The 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 trials | The 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 agency | In 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 granted | The 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 evidence | The 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 recommendation | Once the advisory bodies have given a positive recommendation, the
process of securing the vaccine and arranging implementation can begin. |
| Treasury negotiations | A period of negotiation with the treasury ensues to get the vaccination programme funded. |
| Logistical negotiations | Logistical 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 introduced | Immunisation begins in identified age groups and public campaigns continue to make sure uptake is high. |
| Post-marketing surveillance | This 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 impact | Ongoing 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. |