MONTREAL, Dec. 5, 2018 /CNW/ - Seqirus, a global leader in influenza prevention, today presented a new real-world evidence analysis at the Canadian Immunization Conference (CIC) in Ottawa, Ontario, indicating that its cell-based quadrivalent influenza vaccine (QIVc) was 36.2 percent more effective than standard egg-based quadrivalent vaccine (QIVe) in preventing influenza-like illness (ILI) captured within primary care visits in people aged 4 years and above during the 2017/18 influenza season in the United States, a season characterized by egg-adapted changes.1 This data was based on the effectiveness of the vaccine and there are no head to head efficacy studies comparing QIVc to QIVe.
The 2017/18 season was considered to be one of the worst in recent years due to the predominance of the H3N2 influenza virus.2 Research has shown that some H3N2 viruses undergo changes when they are grown in eggs, and that these changes may reduce the effectiveness of standard egg-based influenza vaccines in H3N2-dominated seasons. When produced completely outside of the egg-based process, cell-based influenza vaccines avoid egg-adapted changes, which means they may offer a closer match and potentially improved protection compared to standard egg-based options in some seasons.3,4,5,6,7,8
The data from this Seqirus commissioned study was generated from one of the largest electronic medical record (EMR) providers for primary care practices in the U.S. Seqirus studied data from 1,353,862 patient records to determine effectiveness of QIVc to prevent ILI compared to QIVe.1
"The burden and impact of influenza remains an important global healthcare concern and ensuring we have effective vaccines is a public health imperative," said Gordon Naylor, President, Seqirus. "As a company on the front line of influenza protection, we are committed to developing innovative solutions, like cell-based vaccines, to help reduce deaths and severe illness caused by influenza."
Seqirus produces cell-based influenza vaccines at its Holly Springs facility in North Carolina. The facility was purpose-built in partnership with the Biomedical Advanced Research and Development Authority (BARDA) to combat pandemic influenza threats.9 BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.
Seqirus licensed QIVc in 2016 and is supplying over 20 million doses to the U.S. market this season.
About the Study1
Real-world data from one of the largest electronic medical record (EMR) providers for primary care practices in the U.S. were obtained between August 1, 2017 and March 31, 2018. Seqirus evaluated these data as a retrospective cohort study which allowed for the estimation of the relative vaccine effectiveness (rVE) of cell-based quadrivalent, inactive influenza vaccine (QIVc) versus egg-based, quadrivalent, inactive influenza vaccine (QIVe).
Researchers analyzed EMRs from 92,192 subjects who received a QIVc and 1,255,983 subjects who received a QIVe to determine which vaccine was more effective in preventing influenza-like illness (ILI). While the effectiveness outcome evaluated in this real-world analysis was not polymerase chain reaction (PCR) confirmed, ILI is an effectiveness outcome used by the Centers for Disease Control (CDC) and World Health Organization (WHO) and reflects exposure and outcome experiences during routine clinical practice. The study population included patients ages 4 years and above who received either QIVe or QIVc in primary care, in the U.S., during this period. Exposures (QIVc or QIVe) were derived from recorded immunizations in individual patients EMRs.
The rVE estimated from the study's primary analysis indicated that QIVc was more effective than standard egg-based QIVs in preventing ILI (rVE of 36.2%, 95% CI (26.1,44.9; P<0.001)). Potential study limitations were minimized using stringent quality control of the data set, cross-referencing the exposure classification step, evaluating two different outcomes code sets for ILI, adjusting for key variables and conducting multiple sensitivity analyses.10
About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, Health Canada encourages annual vaccination for all individuals aged 6 months and older. Because transmission to others may occur one day before symptoms develop and up to 5 days after becoming sick, the disease can be easily transmitted to others. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death. Health Canada estimates that 12,200 Canadians are hospitalized each year due to influenza-related complications. According to Health Canada, it is preferable to administer vaccines before the onset of flu season. However, vaccination is still effective and may be offered until the end of the season.11
Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.
Seqirus was established on 31 July 2015 following CSL's acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.
Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.
Intended Audiences This press release is issued from Seqirus Canada Inc. in Montreal, Quebec, and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
References 1 Boikos T. (2018). Effectiveness of the Cell Culture- and Egg-Derived, Seasonal Influenza Vaccine during the 2017-2018 Northern Hemisphere Influenza Season. Presented at CIC, December 2018. 2 Centers for Disease Control and Prevention (CDC). (2018). Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States — 2017–2018 influenza season. Retrieved from: https://www.cdc.gov/flu/about/burden/estimates.htm Accessed November 2018. 3 Rajaram S., Van Boxmeer J., Leav B., et al. (2018). Retrospective evaluation of mismatch from egg-based isolation of influenza strains compared to cell-based isolation and the possible implications for vaccine effectiveness. Presented at IDWeek 2018, October 2018. 4 CDC. (2018). Advisory Committee on Immunization Practices (ACIP) Presentation Slides: June 2018 Meeting. Retrieved from https://www.cdc.gov/vaccines/acip/meetings/slides-2018-06.html Accessed November 2018. 5 Zost S.J., Parkhouse K., Gumina M.E., et al. (2017). Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. PNAS, 114(47)12578-12583. doi:10.1073/pnas.1712377114. 6 Wu N.C., Zost S.J., Thompson A.J., et al. (2017). A structural explanation for the low effectiveness of the seasonal influenza H3N2 vaccine. PLOS Pathogens, 13(10): e1006682. doi:10.1371/journal.ppat.1006682. 7 The Francis Crick Institute. (2018). Worldwide Influenza Centre: Annual and Interim Reports – February 2018 interim report. Retrieved from https://www.crick.ac.uk/research/worldwide-influenza-centre/annual-and-interim-reports/ Accessed November 2018. 8 CDC. (2018). Cell-Based Flu Vaccines. Retrieved from: https://www.cdc.gov/flu/protect/vaccine/cell-based.htm Accessed November 2018. 9 This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I. 10 Armed Forces Health Surveillance Center (AFHSC): Influenza-Like Illness (ILI). (2015). Retrieved from https://www.health.mil/Reference-Center/Publications/2015/10/01/Influenza-Like-Illness Accessed November 2018. 11 Government of Canada. (2018). Flu (influenza): For Health Professionals. Retrieved from https://www.canada.ca/en/public-health/services/diseases/flu-influenza/health-professionals.html. Accessed December 2018.
For further information: Media Contact: Polina Miklush, +1 (908) 608-7170, [email protected]