Nasal spray vaccine to hit back in 2018-2019 Flu Season

Nasal spray vaccines ready to hit the market again and is projected to capture the market share dramatically.

According to Kalorama Information, this flu season's market will be influenced by the return of nasal spray vaccines. Earlier, The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) did not recommend the nasal flu vaccine during the 2016–2017 and 2017–2018 flu seasons.

However, for the 2018-2019 season, the CDC, in addition to supporting the injectable flu vaccine, also supports the use of the nasal spray vaccine. The healthcare market research firm's recent report, Vaccines 2018: World Market Analysis, Key Players, Trends, Pediatric, and Adult Segments, examines the market for vaccines used in humans to prevent various types of disease, providing a comprehensive market summary.

In that report, Kalorama Information projected a 4.3 billion-dollar flu vaccine market by year end 2018. Delivery mechanisms, along with public awareness, are driving flu vaccine expansion.

"From a market perspective delivery mechanisms add users and are expansive," said Bruce Carlson, Publisher of Kalorama Information.

Different flu vaccines are approved for use in different groups of people. There are flu shots approved for use in children as young as 6 months of age and flu shots approved for use in adults 65 years and older. Flu shots also are recommended for use in pregnant women and people with chronic health conditions. The nasal spray flu vaccine is approved for use in non-pregnant individuals, 2 years through 49 years of age, though there are people with some medical conditions who should not receive the nasal spray flu vaccine.

MedImmune's FluMist was the first influenza vaccine delivered as a nasal mist to be commercially available in the United States. FluMist contains live attenuated influenza viruses that replicate in the nasopharynx of the recipient and are shed in respiratory secretions. In September 2007, the U.S. FDA approved FluMist for children aged 2 through 4 years, making a needle-free influenza vaccine available for small children in the U.S. for the first time. The vaccine was previously approved only for healthy people between the ages of 5 and 49. MedImmune received FDA approval in February 2012 for FluMist Quadrivalent (Influenza Vaccine Live, Intranasal), the first-of-its-kind four-strain vaccine and in mid 2013 began shipping. FluMist suffered a major setback when the ACIP withdrew its recommendation of the nasal/LAIV flu vaccine during the 2016–2017 and 2017–2018 flu seasons.

NanoBio's NanoStat mucosal vaccine platform supports a variety of vaccines including influenza, H5N1, hepatitis B, pneumonia, tuberculosis, smallpox anthrax, and other viral and bacterial diseases. One study in mice demonstrated that NanoBio's killed-virus vaccine elicits a robust immune response by delivering immune-alerting antigens directly to the lining of the nasal mucosa, where the virus first enters the body, leading to rapid development of mucosal immunity. A subsequent study found that NanoBio's intranasal flu vaccine could trigger immune responses more than 20 times greater than those generated by two injections of currently approved influenza vaccines.

In temperate regions, influenza occurs in winter epidemics that affect 1% – 5% of the population. Influenza is associated with a considerable economic burden in terms of health care costs, lost days of work or education and general social disruption. Several studies have estimated the costs of certain recent epidemics at $1 - $2 billion.

Rates of infection are highest in children, but severe morbidity and mortality are more common among the elderly and in specific high-risk groups such as those with asthma, diabetes mellitus, or heart disease. Each year, influenza and pneumonia account for 50,000 to 80,000 deaths and about 400,000 hospitalizations in the United States alone. However, the CDC estimates that flu vaccination prevents, on average, 6 million illnesses, 3 million doctor visits, and at least 70,000 hospitalizations. Therefore, flu vaccines are recommended for everyone 6 months and older, especially pregnant women and those at high risk of complications, including the elderly, children younger than 5 years and those with underlying medical conditions such as asthma or diabetes. According to the American Medical Association, however, just 5% - 20% of the U.S. population is vaccinated against influenza each year.

Unlike other vaccines, whose formulation largely remains unchanged from year to year, influenza vaccines are designed each year to address expected disease patterns. On a global basis, officials choose three flu virus strains each year for the vaccine based on the strains they expect to see in the coming season. Poor selection results in a vaccine that is unable to address the current infection trends.