SummaryNearly 80,000 people died during the 2017–2018 influenza season. Only 37% of adults were vaccinated. Several novel emerging products could make vaccination more accessible and effective, potentially reshaping the market and lowering influenza disease burden.
Influenza vaccination rates have historically remained low, hovering around 43% among adults during the 2016–2017 season and dropping to 37% by the next. CDC estimates that during the 2017–2018 season, influenza infection resulted in 22 million medical visits, nearly 960,000 hospitalizations, and nearly 80,000 deaths, with the highest burden of disease among more vulnerable populations such as those under 4 years and over 65 years of age. New and emerging technologies are poised to reshape the influenza vaccine market landscape and increase vaccination rates. These technologies include:
- Cell-based vaccine production;
- High-dose and adjuvanted vaccines;
- Universal influenza vaccines;
- Non-injectable vaccines; and
- Self-administered vaccines.
Cell-based vaccine production may offer increased protection against influenza, compared to traditional egg-based vaccines.
Cell-based vaccine production can offer several advantages over traditional egg-based production. Start-up times for manufacturing are considerably shorter compared to traditional production, allowing for faster response in the event of another major outbreak like the 2009 H1N1 pandemic. A cell-based vaccine, produced by growing influenza viruses in mammalian cell cultures, avoids inducing virus adaptations, a concern with egg-based production. This method allows for the production of an influenza vaccine more similar to strains circulating in the population during the season, which could increasingly shift demand away from existing egg-based products.
Targeted vaccines induce stronger, more effective immune responses for specific populations, including older adults.
The relatively recent introduction of a targeted, high-dose vaccine indicated for adults over the age of 64, as well as the introduction of an adjuvanted vaccine, could shift demand away from traditional seasonal vaccines to one that currently contains four-times the amount of antigen as traditional vaccines. High-dose vaccines, which contain considerably larger amounts of antigen than other vaccines, are intended to induce a stronger immune response than existing vaccines and may offer increased protection for a more vulnerable population. Adjuvanted vaccines, on the other hand, also aim to induce stronger immune responses, but instead contain an additional ingredient, an adjuvant, to do so. While the FDA is still investigating the difference in effectiveness in people above the age of 65 who received the high-dose vaccine compared to a standard dose, additional research is needed to understand uptake rates within subpopulations, namely older adults, as well as provider prescribing patterns.
A universal influenza vaccine would combat difficulties in matching each season’s vaccine with circulating virus strains, while simultaneously addressing inadequate vaccine uptake.
Each year, the seasonal flu vaccine must be matched with circulating “wild types.” This means that every year, the effectiveness of the flu vaccine varies. With one candidate currently in phase 3 trials, as well as another in phase 1 trials, a universal vaccine could help protect consumers against multiple influenza virus strains. This vaccine could be at least 75% effective against all Type A influenza viruses known to cause significant seasonal illness. It would also protect against H1N1 strains, which were the cause of the most recent 2009 pandemic. While it would not entirely negate the need for a seasonal influenza vaccine, as it would not protect against Type B viruses, it could be more effective than current vaccines. Consumers may be more likely to seek vaccination, as a universal vaccine could increase vaccine confidence.
Non-injectable vaccine technology offers an effective alternative for consumers with fear of needle stick or younger patients for whom receiving an injection may be difficult.
Most recently, the Advisory Committee on Immunization Practices (ACIP) reestablished its recommendation for a non-injectable influenza vaccine, administered using an intranasal spray, for the 2018–2019 season. A painless influenza vaccine may significantly increase uptake, bypassing hesitation resulting from fear of needle stick. As this would make administration significantly easier, there is an opportunity to ease any burden influenza vaccination presents for younger populations and their caregivers. Should this live attenuated quadrivalent vaccine, and future products like it, continue to be as effective as alternative products and maintain ACIP recommendation in future seasons, consumers may increasingly opt for avoiding injected influenza vaccines.
A self-administered influenza vaccine can significantly increase vaccine uptake by addressing various access barriers, making vaccine administration more convenient and easier for consumers.
Possibilities for self-administering influenza vaccines have also entered the pipeline and present another opportunity to change the market landscape, increase access to influenza vaccines, and considerably improve uptake. For example, the development of a microneedle patch containing influenza vaccine will allow consumers to self-apply, like a band aid, and in a matter of minutes administer the vaccine. Perhaps more revolutionary, the product is intended to be heat stable, overcoming traditional challenges associated with vaccine cold chain requirements. The ability to send the vaccine directly to consumers can promote both demand for influenza vaccines and overall uptake.
Special consideration, however, must be given to any self-administered vaccine. There is no FDA precedent for OTC self-administered influenza vaccines and coverage is likely to depend on the demonstration that the self-administered vaccine is as, or more, effective than other influenza products on the market. As with other self-administered products, education may be required before using the product, requiring that either physicians or pharmacists, as well as other health professionals authorized to provide the product, adequately educate consumers.
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