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Recommendations of World Health Organization on the Composition of Influenza Vaccines
Demand for seasonal influenza vaccines is stable and highly concentrated in high - and upper-middle-income countries, which together account for more than 95% of the influenza vaccine market. Only 27 (34%) countries classified by the World Bank as low - or lower-middle income reported seasonal influenza vaccination policies.
There are many manufacturers of seasonal influenza vaccines, but more than 85 percent of the annual production is provided by seven vaccine manufacturers. Four vaccine manufacturers produce improved seasonal flu vaccines, which account for only 10 percent of existing flu vaccines.
Picture of the WHO building.
Demand for seasonal influenza vaccines is expected to increase by about 10% over the next 10 years, with significant potential for increased use - especially in low - and middle-income countries, although funding and prioritising it over other health interventions is needed. Limited investments in health worker and maternal vaccination could have huge health and programming benefits.
In the absence of the withdrawal of multiple influenza vaccine manufacturers, the supply of seasonal influenza vaccine is sufficient to meet current and projected national needs. Where there is demand in the lowest-income countries, country-specific vaccine availability and suitability needs to be developed.
Vaccines under development with faster manufacturing processes have the potential to improve existing vaccines and significantly increase the available supply for commercial use in the medium term.
In the short term, there is some acquisition risk due to the regulatory and implementation complexity necessary to remove the B/Yamagata strain from the quadrivalent vaccine as recommended by WHO. Taking into account the needs and constraints of Member States, regulators and industry, there is a need for greater coordination to ensure a successful transition from quadrivalent influenza vaccine (QIV) to trivalent influenza vaccine (TIV).
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Influenza Vaccine Market Background
National policies governing the use of influenza vaccines vary. As of November 2023, 123 (63%) countries reported implementation of influenza vaccination policies through the WHO/UNICEF Joint Reporting Form. This includes 96 countries (85%) classified by the World Bank as high-income (HIC) or upper-middle income (UMIC) countries. Of the countries with policies in place, 74 (60%) recommend vaccination for all WHO focus groups, and 41 (33%) report that their policies exceed WHO recommendations to cover the entire population. In contrast, only 27 low income (LIC) and low middle income (LMIC) countries (34%) had policy recommendations to support public financing, procurement or use of seasonal influenza vaccines, highlighting the uneven use of seasonal influenza vaccines across different income groups and hence the opportunity for demand growth.
The above reasons have led to a high concentration of seasonal influenza vaccine consumption. In 2022, high-income and middle-income countries consumed 97% of global seasonal influenza vaccine production, with 92% of consumption coming from the regions of the Americas, Europe and the Western Pacific. Vaccine use is also concentrated in five countries, which account for 55 percent of the global total. Adult QIV accounts for 65% of global seasonal influenza vaccine consumption. Access to improved seasonal influenza vaccines remains limited and is concentrated in high-income countries.
The constant evolution of influenza viruses requires that the influenza strains in the vaccine be updated every two years to match the circulating influenza viruses. To cope with the seasonality of influenza transmission, the timing of production and vaccination varies to meet demand in the northern and southern hemispheres, resulting in a semi-annual cycle of supply and demand.
In 2022, seasonal influenza vaccines produced using strains circulating in the Northern Hemisphere accounted for 64% of global production, seasonal influenza vaccines produced using strains circulating in the Southern hemisphere accounted for 20% of global production, and vaccines used in countries using strains circulating in both the Northern and southern hemispheres accounted for 15% of global production.
Since 2012, the seasonal influenza vaccine consists of two influenza A strains and one influenza B strain in TIV, with the B/Yamagata strain added to QIV. The two most common seasonal flu vaccines are :1) inactivated vaccines produced from eggs or cell cultures, and 2) live attenuated vaccines (LAIV), which account for 98% and 2% of seasonal flu vaccine production in 2022, respectively.
Globally, flu vaccines are mainly produced by 30 manufacturers, seven of which account for more than 85% of the global supply, with the rest primarily serving local markets. The headquarters of volume producers vary, but 75% are in Europe and Asia. In 2022, seven of the top 10 producers by volume have registered vaccines and are providing vaccines to more than 10 countries (range 10-72). Nineteen manufacturers supply vaccines to both hemispheres, 10 only to strains circulating in the Northern Hemisphere and one only to strains circulating in the southern hemisphere. As of 2022, 16 producers supply both TIV and QIV, 5 supply TIV only and 9 supply QIV only. Notably, the production capacity of six manufacturers was supported by the WHO Technology Transfer Initiative.
There are at least 122 seasonal flu vaccines on the market, made by 42 companies, 12 of which only canning and processing the vaccine. Twenty vaccines from 10 manufacturers have been pre-certified for WHO qualification. Some countries use modified vaccines for specific target groups, including vaccines that contain adjuvants, have a higher antigen content or are made with recombinant antigens. Only 10 percent of existing vaccines, which are supplied by four large manufacturers, are considered improved.
In September 2023, WHO recommended that "B/Yamagata antigen is no longer necessary as a component of influenza vaccines and every effort should be made to exclude it as soon as possible." This proposal has the potential to change the current market dynamics, as it is expected that QIV may be phased out, reverting to the exclusive use of TIV. National regulatory authorities and vaccine manufacturers will play a key role in implementing the WHO recommendations.
Global Supply Available for Commercial Use
Consultations with manufacturers and experts, as well as a review of publicly available information on seasonal influenza vaccines, provide a basis for assessing the current and future global availability of seasonal influenza vaccines for commercialization (ASC). As of November 2023, there are 29 seasonal influenza vaccines in clinical development, of which 27 can be considered improved vaccines.
Twenty of the vaccines are based on nucleic acid (NA) technology and are partly influenza vaccines alone and partly combined vaccines that combine influenza with other respiratory pathogens. Adjuvant vaccines, high-dose vaccines, vaccines with innovative delivery systems, and recombinant vaccines represent improved vaccines in the pipeline. Vaccines that are considered to have universal and broad protection against influenza viruses have been excluded because the likelihood of these vaccines being marketed in the time frame covered by this study is low.
Of the 29 seasonal flu vaccines in development, 21 are being developed by nine new manufacturers, so there is a good chance of increasing market supply. Two of them are responsible for developing 12 pipeline vaccines. The remaining eight pipeline vaccines are being developed by the four manufacturers of existing seasonal flu vaccines. New vaccines developed by existing seasonal influenza vaccine manufacturers will potentially replace currently produced vaccines and are therefore unlikely to increase ASC.
Nucleic acid-based vaccines account for 69% of influenza vaccines in clinical development. One of the potential benefits of nucleic acid-based vaccines is that they can be produced relatively quickly, potentially reducing the time lag between strain selection and vaccination, and thus, theoretically, improving their effectiveness by improving the matching of circulating influenza strains to those contained in the vaccine. To realize this potential benefit, the global strain selection system needs to be revised.
As of 2023, ASC has 1.2 billion doses of trivalent influenza vaccine. A base scenario simulates a modest increase in ASC from the current manufacturer and the entry of a pipeline vaccine, resulting in a 1.8-fold increase in ASC over the current long-term. To assess a range of future supply scenarios, we developed various scenarios to simulate the impact of market exit, increased production from existing manufacturers, and pipeline products entering the market at different rates.
- Low scenario model: limited market exit. The small increase in ASC from current manufacturers and the limited success of pipeline vaccine supplies resulted in a 1.6-fold reduction in ASC in the short term.
- High scenario model: no market exit, modest ASC increases from existing manufacturers, and optimism about clinical development progress of pipeline vaccines. In the long term, ASC will increase threefold, and accounting for the acceleration of vaccine supply could lead to ASC increases of up to four times. Large increases in the cost of all medium - and long-term services will only be realized if there is a large increase in demand, so careful coordination and planning are required.
- Very low scenario model: Even a very low probability worst-case scenario, assuming that several current producers exit the market, will result in a 2x reduction in ASC in the short term. In the long run, without an increase in ASC from remaining producers in the market or new market entrants, the ASC will remain below the current ASC in the base scenario.
For manufacturers supplying both hemispheres and producing both TIV and QIV vaccines, the ASC may be adjusted to some extent based on the proportion of TIV or QIV supplied annually and the Northern or Southern Hemisphere influenza vaccine volume.
* Only for research. Not suitable for any diagnostic or therapeutic use.
