First cell-based quadrivalent influenza vaccine approved for use in Europe

This news release is intended for Health Professional media only.

news
  • Seqirus to launch its cell-based influenza vaccine in Europe for the 2019-20 season
  • Real-world data indicates cell-based influenza vaccines may be more effective than standard options in seasons affected by egg-adaptation

 

Maidenhead, UK, 14 January 2019 - Seqirus, a global leader in influenza prevention, today announced that the European Commission has issued marketing approval for its new cell-based seasonal influenza vaccine, FLUCELVAX® TETRA [influenza vaccine (surface antigen, inactivated, prepared in cell cultures)]. This will be the first cell-based quadrivalent influenza vaccine (QIVc) available in Europe and is licensed for use in people nine years and above. Cell-based technology represents one of the most significant changes in the way influenza vaccines are manufactured since the 1940s.

At the Canadian Immunisation Conference (CIC) in December 2018, Seqirus presented an analysis of over 1.3 million medical records indicating that QIVc was 36.2 percent more effective than standard egg-based quadrivalent vaccines (QIVe) in preventing influenza-like illness in people aged 4 years and above during the 2017-18 influenza season in the U.S.1  This particular influenza season in the U.S. is considered to be one of the worst in recent years due to the predominance of the H3N2 virus.2

Research has shown that some H3N2 viruses undergo changes when they are grown in eggs, leading to the hypothesis that these changes may reduce the effectiveness of standard egg-based influenza vaccines in H3N2-dominated seasons. When the H3N2 component of cell-based vaccines are produced completely outside of the egg-based process, it may offer a closer match and potentially improved protection against the circulating H3N2 strain compared to standard egg-based options.3,4,5,6,7,8 

There have been no randomised controlled trials comparing the efficacy of QIVe and QIVc and while real-world studies are becoming an important approach to understanding the effectiveness of influenza vaccines, the results of the QIVc study presented at the CIC are based on a single influenza season. FLUCELVAX TETRA was approved by the EMA on the basis of immunogenicity and safety of the QIVc compared to a cell-based trivalent influenza vaccine.9

“This real-world study, along with other emerging evidence, indicates that cell-based influenza vaccines may result in better influenza-related outcomes compared to standard egg-based vaccine options in some seasons, particularly those seasons characterised by egg-adapted changes,” said Russell Basser MD, SVP of Research and Development, Seqirus. “We are greatly encouraged by the data and look forward to working with academic partners to generate additional data in future seasons.”

In the UK, the potential advantages of QIVc have already been recognised in guidance issued by the Joint Committee on Vaccination and Immunisation (JCVI) for the 2019-20 influenza season.14  JCVI advised QIVc would be suitable for use in people aged 65 years and above, as well for use in at-risk groups aged under 65.  FLUCELVAX TETRA is now available to order in the UK.

Developing new and better influenza vaccine technologies is a strategic priority for Seqirus, including further advances in cell-based technology and the use of adjuvants to enhance the immune response.

“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 pleased to make our cell-based technology available in Europe to help reduce deaths and severe illness caused by influenza.”

The company has rapidly scaled up cell-based influenza vaccine production over recent years, which has enabled sufficient quantities of the vaccine to be available for real-world effectiveness studies, and to allow supply of the vaccine in Europe for the 2019-20 influenza season.

Seqirus produces cell-based influenza vaccines at its Holly Springs facility in North Carolina in the U.S. The facility was purpose-built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to combat pandemic influenza threats.10 

The European Commission issued its approval of FLUCELVAX TETRA on 14 December 2018.

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 analysed 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 immunisations 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 minimised 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.11

About seasonal influenza

Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalisation and in some cases death.12  Because airborne or touch transmission to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease is highly contagious.13  To reduce the risk of more serious outcomes, such as hospitalisation and death, the NHS encourages annual vaccination for all younger children, people aged 18-64 in high risk groups and all aged 65 and over.15 

About Seqirus

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.

For more information visit www.seqirus.com and www.csl.com.

 

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Media Contact

For further information or to request an interview, please contact Becky Roberts

Tel:        07960 718712

Email:   becky.roberts@bairdscmc.com

 

Intended Audiences
This press release is issued from Seqirus in Maidenhead UK, 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.

Forward-Looking Statements
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 NFID Clinical Vaccinology Course, November 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 Influenza Vaccines. Retrieved from: https://www.cdc.gov/flu/protect/vaccine/cell-based.htm Accessed November 2018.

9 European Medicines Agency. Flucelvax Tetra information page. Retrieved from: https://www.ema.europa.eu/en/medicines/human/EPAR/flucelvax-tetra Accessed January 2019.

10 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.

11 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.

12 CDC. (2018). Key facts about seasonal influenza vaccine. Retrieved from: http://www.cdc.gov/flu/protect/keyfacts.htm Accessed November 2018.

13 CDC. (2018). How influenza spreads. Retrieved from: https://www.cdc.gov/flu/about/disease/spread.htm Accessed November 2018.

14 UK Joint Committee on Vaccination and Immunisation (JCVI). JCVI advice on influenza vaccines for the 2019-20 influenza season. Retrieved from: https://app.box.com/s/t5ockz9bb6xw6t2mrrzb144njplimfo0/file/334815965677 Accessed November 2018.

15 UK National Health Service. Who should have the flu vaccine? Retrieved from:

https://www.nhs.uk/conditions/vaccinations/who-should-have-flu-vaccine Accessed December 2018.