Abstract

The WHO Global Action Plan on Influenza Vaccines (GAP) started as a global multi-partner initiative in 2006 in conjunction with the Pandemic Influenza Preparedness Framework. GAP addresses the “vaccine part” of the international pandemic response which incorporates the virus/benefit sharing principle through promotion of equitable geographical distribution in pandemic vaccine production capacity.  The GAP aims at ensuring the protection of all populations worldwide through vaccination in the event of an influenza pandemic.

Three main objectives are being pursued: (1) increase in evidence-based seasonal influenza vaccine use, considered to be a necessary pre-requisite to achieve global pandemic preparedness, (2) increase of global pandemic vaccine production capacity, amongst others through capacity building via technology transfer in low and middle income counties, including Viet Nam and (3) promote research and development of new influenza vaccines that are better and that can be produced faster and in sufficient quantities.

Since the initiation of the GAP significant progress has been made in all main objectives: seasonal vaccine uptake has been on the increase in Latin America and globally the number of countries with a policy on influenza use has increased to 165, although against this overall increase a decrease in seasonal vaccine distribution in Europe is reported by international influenza vaccine manufacturers; potentially associated with increasing vaccine hesitancy. In 2012, WHO recommended to vaccinate pregnant women which has been followed by many countries. Seasonal vaccine production capacity has nearly tripled since the start of GAP and this capacity is now spread across a larger number of countries. This global capacity would still fall short in case of a pandemic however, in particular if 2 doses would be needed to protect from disease. While there has been a wealth of developments in improved influenza vaccines including recombinant vaccines, low-dose adjuvanted vaccines, and new live attenuated influenza vaccines being approved, the long term objective of broadly cross-reactive ‘universal’ influenza vaccines still remains several years away.  

The ambitious target originally set is turning out to be difficult to reach with the existing technology and the world will not be protected against a pandemic threat with the current arsenal of available vaccines. The experience obtained till date in low and middle income countries show that establishing and maintaining a sustainable influenza vaccine manufacturing facility is a challenge and requires not only technical know-how and infrastructure, but also a seasonal market and above all coherence in national policies on health, regulatory oversight, industrial and science and technology development.

From this perspective, the GAP experience in Viet Nam is encouraging. Since 2006, WHO has with BARDA and PATH supported the Institute of Vaccines and Medical Biologicals (IVAC) in Nha Trang in establishing pandemic and seasonal influenza vaccine capacity, which recently led to important milestones as will be reported by others in this meeting. Viet Nam is a highly populated country with a track record on developing and producing vaccines for its own population, as exemplified by the development and licensing of an oral cholera vaccine. On the regulatory side, Viet Nam made efforts to improve the National Regualtory Authority (NRA) to international standards and a recent WHO assessment of the NRA concluded that it is close to being fully competent. Viet Nam is on the way to build with international partners a pandemic influenza preparedness strategy that includes indigenous influenza vaccine manufacturing that can be sustainable, subject to a yet-to-be established seasonal influenza vaccination policy.