Global production capacity of seasonal and pandemic influenza vaccines in 2019

Abstract

Vaccines will be an important element in mitigating the impact of an influenza pandemic. While research towards developing universal influenza vaccines is ongoing, the current strategy for vaccine supply in a pandemic relies on seasonal influenza vaccine production to be switched over to pandemic vaccines. Understanding how much vaccine could be produced, in which regions of the world and in what timeframe is critical to informing influenza pandemic preparedness. Through the Global Action Plan for Influenza Vaccines, 2006-2016, WHO promoted an increase in vaccine production capacity and monitors the landscape through periodically surveying influenza vaccine manufacturers. This study compares global capacity for production of influenza vaccines in 2019 with estimates from previous surveys; provides an overview of countries with established production facilities; presents vaccine production by type and manufacturing process; and discusses limitations to these estimates. Results of the current survey show that estimated annual seasonal influenza vaccine production capacity changed little since 2015 increasing from 1.47 billion to 1.48 billion doses with potential maximum annual influenza pandemic vaccine production capacity increasing from 6.37 billion to 8.31 billion doses. However, this figure should be interpreted with caution as it presents a best-case scenario with several assumptions which may impact supply. Further, pandemic vaccines would not be immediately available and could take four to six months for first supplies with several more months needed to reach maximum capacity. A moderate-case scenario is also presented of 4.15 billion doses of pandemic vaccine in 12 months. It is important to note that two doses of pandemic vaccine are likely to be required to elicit an adequate immune response. Continued efforts are needed to ensure the sustainability of this production and to conduct research for vaccines that are faster to produce and more broadly protective taking into account lessons learned from COVID-19 vaccine development.

Keywords: Capacity; Influenza; Pandemic; Production; Seasonal; Vaccine.

Fig. 1

Countries with influenza vaccine production and fill/finish facilities in 2019 (active or in late stage development).

Fig. 2

Estimated total annual seasonal production capacity over time (since 2006).

Fig. 3

Estimated potential annual pandemic production capacity over time (since 2006). Best case scenario – manufacturers would be able to operate at full scale with no limitations on supplies/reagents, the pandemic strain would grow equally well in eggs/cells as seasonal strains and the same amount of antigen as normally used for each seasonal strain would be enough to elicit an adequate immune response. Moderate case scenario – manufacturers would be able to operate at full scale with no limitations on supplies/reagents, the pandemic strain would grow equally well in eggs/cells however twice the amount of antigen as per each strain of seasonal would be required to elicit an adequate immune response.

Fig. 4

Timeline of pandemic vaccine production (IIV) .