Amongst infectious diseases influenza regularly wins the pole position due to the particulars of seasonal epidemiology and the persistent risk of emerging pandemic influenza virus strains. While the logistics behind manufacturing and delivery of seasonal influenza vaccines are manageable in industrialized countries less wealthy regions of the world are often underprivileged regarding sufficient and timely procurement with appropriate vaccines.
Similarly, production and timely delivery of pandemic influenza vaccines remains a challenge for the entire world again putting wealthier countries in a more comfortable position compared to low and middle income countries (LMIC).
However, even in case resources would be more evenly distributed around the globe the question arises whether currently available influenza vaccines are indeed suitable to effectively counteract the numerous health threats caused by circulating influenza viruses.
In fact, closer monitoring of effectiveness of seasonal influenza vaccines regularly reveals the weaknesses of many products. Very often clinical effects even against vaccine matched circulating strains are rather low and almost no effect is observed against drift variants of the vaccine contained strain(s). Thus, justification of the usefulness of seasonal influenza vaccination programs becomes rather sophisticated specifically for the classic risk populations where effectiveness usually is even lower compared to a healthy population.
Moreover, poor effectiveness of seasonal influenza vaccines raises the question whether introduction of vaccination programs in regions with more complex epidemiological patterns compared to the northern or southern hemisphere, e.g. tropical or equatorial regions where circulating strains may differ even more from a given vaccine formulation, can indeed be declared as a first priority task.
Facing these severe constraints WHO is actively searching for new influenza vaccines that will better meet the requirements important for many parts of the world. Consequently, WHO has recently launched a document for public consultation that defines criteria to be met by better or next generation influenza vaccines. The goal of this document called “Preferred Product Characteristics for Next Generation Influenza Vaccines" is to promote research and development of next generation influenza vaccines for use in LMICs, where the burden of severe influenza disease is the highest. It is intended to emphasize the data needs to drive policy making and vaccine use in LMIC settings. WHO is posting the document for public comment through 7 November 2016. A next version of the PPC document will be produced after review of the public comments, and the revision will be subsequently reviewed by the WHO Product Development for Vaccines Advisory Committee (PDVAC) for potential endorsement as a formal WHO document.
Scientific and regulatory aspects related to that document have been intensively discussed during the “Eighth WHO meeting on development of influenza vaccines that induce broadly protective and long-lasting immune responses” held in Chicago from 23 to 24 August, 2016.
The meeting brought together stakeholders from around the world in order to facilitate development, financing as well as licensure of novel influenza vaccines. Amongst many important factors that need to be considered in order to get better influenza vaccines on the market as soon as possible, regulatory aspects play a specific role in order to ensure success of investments made in those projects. More information on the meeting you find HERE.
Virtually simultaneously to these intense WHO activities also EMA has released the second part of the guidance for influenza vaccines, i.e. the non-clinical and clinical module. This module follows the quality module which came into effect end of 2014. Both documents together for the first time provide comprehensive guidance to industry regarding existing and future influenza vaccine:
An important and unique aspect of the new EMA guidance is that it covers licensed as well as novel influenza vaccines aimed at introducing common scientific standards to all influenza vaccines which has so far not been the case. The main focus, however, is the same as the one defined by WHO, namely to make available better influenza vaccine in the shortest possible period of time since they are urgently required for the EU and the world in order to maintain trust in yearly vaccination programs and to ensure better and fairer influenza preparedness around the world.
Thus, developers and manufacturers of influenza vaccines from now on will have to follow these initiatives and adapt or develop their products according to this new scientific and regulatory framework. Since members of the Biopharma Excellence team were deeply involved in setting up these standards as well as of strategies to translate these standards into products we are ready in assisting interested parties in reaching these goals.