Lessons from pandemic influenza A(H1N1): The research-based vaccine industry's perspective

Abstract

As A(H1N1) influenza enters the post-pandemic phase, health authorities around the world are reviewing the response to the pandemic. To ensure this process enhances future preparations, it is essential that perspectives are included from all relevant stakeholders, including vaccine manufacturers. This paper outlines the contribution of R&D-based influenza vaccine producers to the pandemic response, and explores lessons that can be learned to improve future preparedness. The emergence of 2009 A(H1N1) influenza led to unprecedented collaboration between global health authorities, scientists and manufacturers, resulting in the most comprehensive pandemic response ever undertaken, with a number of vaccines approved for use three months after the pandemic declaration. This response was only possible because of the extensive preparations undertaken during the last decade. During this period, manufacturers greatly increased influenza vaccine production capacity, and estimates suggest a further doubling of capacity by 2014. Producers also introduced cell-culture technology, while adjuvant and whole virion technologies significantly reduced pandemic vaccine antigen content. This substantially increased pandemic vaccine production capacity, which in July 2009 WHO estimated reached 4.9 billion doses per annum. Manufacturers also worked with health authorities to establish risk management plans for robust vaccine surveillance during the pandemic. Individual producers pledged significant donations of vaccine doses and tiered-pricing approaches for developing country supply. Based on the pandemic experience, a number of improvements would strengthen future preparedness. Technical improvements to rapidly select optimal vaccine viruses, and processes to speed up vaccine standardization, could accelerate and extend vaccine availability. Establishing vaccine supply agreements beforehand would avoid the need for complex discussions during a period of intense time pressure. Enhancing international regulatory co-operation and mutual recognition of approvals could accelerate vaccine supply, while maintaining safety standards. Strengthening communications with the public and healthcare workers using new approaches and new channels could help improve vaccine uptake. Finally, increasing seasonal vaccine coverage will be particularly important to extend and sustain pandemic vaccine production capacity.

Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects

“…In particular, prompt and large production of vaccine is one of the most important requirements for better respond to the influenza pandemic. 7 Actually, during the 2009 Figure 3. Superiority of NBP607-QIV over NBP607-TIV on immunogenicity for B/Yamagata or B/Victoria strain at 21 days post-vaccination.…”

Respiratory viral testing

“…Culture for viruses like influenza will remain important for differentiating prolonged detection of nucleic acids from continued shedding of virus and potential antiviral resistance, subtyping of novel strains and propagation for vaccine manufacturing. 6,7 Commonly-used rapid shell vial culturing techniques combined with specific direct fluorescent antibody demonstrated sensitivities ranging from 90-97% and 100% specificity for pandemic H1N1 (pH1N1), but complexity of use and 2-3 d turnarounds still limit their impact on clinical care. 5,6,8 Rapid antigen tests are inexpensive and easy to use, making them ideal for point-of-care testing in places like physician offices and emergency rooms and their high specificity in times of high disease prevalence allows their high positive predictive value to aid in timely treatment, limiting unnecessary resource utilization.…”

Comparison of Real-Time Polymerase Chain Reaction and Conventional Cell Culture for Detection of Influenza A in Tabriz, Iran

“…People should know that washing mouth and throat with salted water can be the most efficient protection of influenza epidemics and pandemics (19). Moreover, increasing the seasonal vaccine production will enlarge the pandemic vaccine capacity (20).…”