Pandemic Influenza

This information is intended for global use. Please consult the appropriate country-specific Baxter website for more information. Some statements about products or procedures may differ from the licensed indications in specific countries. Therefore, always consult the country-specific summary of product characteristics (SPC), package leaflets or instructions for use. For more information, please contact a local Baxter representative.

Baxter's Vero cell technology for the production of influenza vaccines

Human vaccines against seasonal influenza have been available for close to 70 years. Even though the manufacturing processes have undergone considerable development over the years, the process is still closely related to that devised in the 1940s. Most of today's seasonal and pandemic influenza vaccines are grown in embryonated chicken eggs, chemically inactivated, and purified.1

Vero cells have been widely used for human vaccine production e.g. polio and rabies over the past three decades.10 Baxter's proprietary Vero cell technology uses a well-established mammalian cell line that has been extensively tested11 and is fully accepted by regulatory authorities in both Europe and the USA for the production of human vaccines.12 Baxter's Vero cell platform is one of the most advanced cell culture systems for the production of both seasonal* and pandemic influenza vaccines. 13

In contrast to the use of embryonated chicken eggs, Baxter's Vero cell-based manufacturing uses a highly standardized, closed production process13, ensuring freedom from interaction between the vaccine and its environment, and has high purity in the absence of antibiotics.

Another major advantage of the Vero cell line is that it can be grown and infected on microcarrier beads and cultivated in fermenters, allowing large-scale production of vaccines. 13

*The license for Baxter's seasonal influenza vaccine is pending approval. 9

Baxter's Vero cell technology production process:

Seasonal influenza...

  • ...is an acute contagious illness with systemic and respiratory symptoms.
  • ...is caused by human influenza viruses type A or B and should not be confused with the common cold, which is caused by other viruses, such as rhinoviruses and coronaviruses.
  • ...can affect all age groups, the risk being highest among the elderly, and people of any age with certain chronic diseases or a weakened immune system.2
  • ...kills an estimated 40 000 people annually in the European Union.2

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Pandemic influenza...

  • ...occurs when a novel strain of the influenza virus emerges, capable of spreading worldwide and for which there is little or no human immunity.
  • ...is easily transmitted from human to human, can cause serious illness and, as a result, can lead to enormous numbers of deaths.
  • ...occurred three times in the past century; the 1918 pandemic was the most severe and killed 20-40 million people worldwide.3
  • ...has occurred for the first time in the 21st century, when a new influenza A virus was identified in April 2009.

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A(H1N1) Pandemic influenza...

  • ...according to preliminary epidemiological data, in contrast to seasonal influenza, the A(H1N1) pandemic strain shows higher infection rates in younger age groups than in the elderly, possibly due to partial immunity from former infections with H1N1 influenza viruses. 4-7
  • ...recommendation is currently to vaccinate priority groups such as individuals less than 65 years old with chronic underlying conditions, young children, and pregnant women.8

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References

1. Kamps BS, Hoffmann C, Preiser W.Influenza Report 2006. www.InfluenzaReport.com

2. European Centre for Disease Prevention and Control (ECDC). Influenza - Fact sheet for citizens [http://ecdc.europa.eu/en/Health_Topics/Seasonal%20Influenza/factsheet_citizen.aspx].

3. Hien TT, de Jong M, Farrar J, Avian influenza – a challenge to global health care structures. N Engl J Med 2004; 351:2363-5.

4. Novel Swine-Origin Influenza A (H1N1) Virus Investigation Team. Emergence of a Novel Swine-Origin Influenza A (H1N1) Virus in Humans. N Engl J Med 2009; 360:2605-15.

5. ECDC working group on influenza A(H1N1). Preliminary analysis of influenza A(H1N1)v individual and aggregated case reports from EU and EFTA countries. Eurosurveillance, Volume 14, Issue 23, 11 June 2009.

6. Gilsdorf A, Poggensee G, on behalf of the working group pandemic influenza A(H1N1)v. Eurosurveillance, Volume 14, Issue 34, 27 August 2009.

7. MMWR. Use of Influenza A(H1N1) 2009 Monovalent Vaccine. August 28, 2009; 58 (RR10);1-8

8. ECDC Interim Guidance. Use of specific pandemic influenza vaccines during the H1N1 2009 pandemic, August 2009. Available from http://ecdc.europa.eu/en/publications/Publications/0908_GUI_Pandemic_Influenza_Vaccines_during_the_H1N1_2009_Pandemic.pdf

9. [www.clinicaltrials.gov] search criteria: seasonal influenza vaccine, vero cell derived, Baxter.

10. Vidor E, Meschievitz C, Plotkin S. Fifteen years of experience with Vero-produced enhance potency inactivated poliovirus vaccine. Pediatr. Infect. Dis. J. 1997; 16 : 312-22

11. Kistner O, Barrett PN, Mundt W, Reiter M, Schober-Bendixen S, Dorner F. Development of a mammalian cell (Vero) derived candidate influenza virus vaccine. Vaccine 1998; 16:960-8.

12. Howard MK, Kistner O, Barrett PN. Pre-clinical development of cell culture (Vero)-derived H5N1 pandemic vaccines. Biol Chem 2008; 389:569-77.

13. Barrett PN, Mundt W, Kistner O, Howard MK. Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines. Expert Rev Vaccines 2009; 8:607-18