Did you know that with the exception of safe drinking water, no other public health intervention has had such a major impact upon mortality reduction as vaccines have had? Figures talk by themselves. In 2012 alone, 111 million children were given vaccines against life threatening diseases, preventing some 2 to 3 million deaths that year. Yet, the supply chains linked to these two major health interventions, supply of safe drinking water and vaccines, are not always guaranteed nor can they be taken for granted.
I just wonder how many of us know how complex is the journey a vaccine must go through. Connecting the dots between a desperately needed vaccine to a child somewhere out there waiting to be given that silver bullet shot against deadly or crippling diseases can be very challenging.
This is precisely what this new publication, “The Complex Journey of a Vaccine”, is all about. With it, the IFPMA hopes to clearly illustrate the steps that the manufacturers undertake in order to ensure the quality and safety of the vaccine and some of the challenges they face along their way. These mainly revolve around how to ensure a reliable supply of sufficient quantities of vaccines whilst meeting the different regulatory demands that may differ from a country to another at the national health authority level.
Here is a shocker: It can take up to 2 years from the start of the manufacturing process to the final Quality Assurance release of a vaccine. During this time, the vaccine will have undergone many hundreds of tests: tests that assure the quality of everything from the many raw materials that are used in the manufacturing process right through to final vaccine that will be administered to the child.
Every time a manufacturer wants to introduce a change into the production process, be it small or big, it must be ‘green lighted’ by the relevant national health authorities before implementation. The number of changes that may be needed during the products life cycle and the complex regulatory review process, added to the lengthy procedures may all jeopardize the reliability of supply. Understandably, the national regulatory authorities also have a critical job to ensure that high quality and safe vaccines are distributed in a timely manner in their country.
I hope that this brochure helps you understand what’s at stake in the manufacturing segment of The Complex Journey of a Vaccine. To get a better grasp of the whole picture, we are also working on new infographics to illustrate the delivery and R&D segments to be published in the near future.
IFPMA member companies will continue to do their utmost to secure the availability of high quality vaccines in the quantities that are needed. After all, just as safe drinking water is essential for health, vaccines also play a vital role in securing the health and wellbeing of everyone on this planet.