Cell-based vaccine
Cell-based vaccine is a type of vaccine developed from mammalian cell lines rather than embryonic chicken eggs.[1] The potential use of cell culture techniques in developing viral vaccines, especially for the Influenza virus, has been widely investigated in recent years as a complementary and alternative platform to the current egg-based strategies.[1][2]
Advantages of cell lines
The main benefit is the ability to rapidly produce vaccine supplies during an impending pandemic. Other benefits are the avoidance of egg-based allergy reactions. In addition, cell lines can be grown in synthetic media avoiding animal serum. This prevents the spread of transmissible spongiform encephalopathies.[1][3][4]
Approved cell-based vaccines
Flucelvax
The United States Food and Drug Administration approved Flucelvax as the first mammalian cell-based Influenza vaccine in the United States on November 20, 2012. The vaccine was produced by Novartis through culturing of the Madin-Darby canine kidney (MDCK) cell line.[5] Specifically, Flucelvax targets three Influenza sub-types which includes Influenza A subtype H1N1, Influenza A subtype H3N2, and Influenza B. The vaccine is aimed towards individuals over the age of 18. In clinical trials, Flucelvax exhibited similar levels of vaccine efficacy and immunogenicity as traditional egg-based vaccines.[6]
Optaflu
Optaflu, also produced by Novartis, was approved by the European Medicines Agency in 2009 for use in countries affiliated with the European Union. Optaflu is nearly identical to Flucelvax; it is also produced in MDCK cells and targets the same Influenza subtypes.[7] The main differences are in release specifications for measuring vaccine lots' safety, efficacy, and quality, mostly due to differences between U.S. and European regulatory standards and tests.[8]
References
- 1 2 3 Audsley JM, Tannock GA. Cell-based influenza vaccines: progress to date.Drugs. 2008;68(11):1483-91.
- ↑ Wong SS, Webby RJ. Traditional and New Influenza Vaccines. Clinical Microbiology Review. 2013;26(3):476-492.
- ↑ "FDA clears first cell-based flu vaccine | CIDRAP". Cidrap.umn.edu. 2012-11-21. Retrieved 2013-09-24.
- ↑ "Vaccine Production in Cells". Flu.gov. 2006-07-17. Retrieved 2013-09-24.
- ↑ "Cell-based Flu Vaccines". CDC.gov. Retrieved 2013-11-10.
- ↑ "Flucelvax Product Information" (PDF). FDA.gov. February 2013. Retrieved 2013-11-10.
- ↑ Doroshenko A, Halperin S. Trivalent MDCK cell culture-derived influenza vaccine Optaflu® (Novartis Vaccines). Expert Reviews. 2009;8(6):679-688.
- ↑ "Summary Basis of Regulatory Action" (PDF). FDA. 2012-11-20. Retrieved 2015-09-10.
The main differences in manufacturing between FLUCELVAX and Optaflu are limited to minor differences in release specifications and the methods used to calculate HA concentration.