RECOMBINANT TECHNOLOGY
AN ADVANCE IN INFLUENZA VACCINE MANUFACTURING TECHNOLOGY


Supemtek (Quadrivalent Influenza Vaccine, recombinant prepared in cell-culture), is manufactured using recombinant technology.1

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Recombinant technology eliminates the possibility of adaptation or mutation during the manufacturing process by replicating only the haemagglutinin (HA) antigen direct from a genetic sequence. The resulting antigens are an exact genetic match to the target strain.2,3

In the production of Supemtek, the HA antigen DNA for each World Health Organization
(WHO)-recommended influenza strain is combined with host cell DNA.1,3 Because only the DNA for each influenza antigen is used, there is no live virus replication during the recombinant process.3

Supemtek contains 3x more HA antigen (45 mcg versus 15 mcg) per strain compared with cell- and egg-based standard-dose quadrivalent influenza vaccines.2


HOW DOES RECOMBINANT TECHNOLOGY WORK?1,3,4

  1. Once the WHO has identified and announced the predicted strains for the upcoming influenza season, the first step of vaccine manufacturing can begin
  2. The genetic code for each HA antigen of the four target influenza strains is sequenced by the WHO. Rather than provide a candidate vaccine virus (CVV), the newly sequenced code can be sent via email
  3. HA antigen DNA sequences of interest are inserted into a transfer vector for recombination with a baculovirus for expression
  4. The baculovirus containing target HA DNA is then imported into an insect host cell
  5. The host cells are grown to produce large quantities of antigen for each of the target strains
  6. Once host cell cultures have been grown, the HA proteins are harvested and purified
  7. The recombinant influenza product is then formulated into the influenza vaccine

RECOMBINANT TECHNOLOGY GENERATES HA ANTIGENS THAT ARE AN EXACT GENETIC MATCH TO THE TARGET STRAINS2,3


Baculovirus imported into host cell graphic Arrow Baculovirus imported into host cell graphic Arrow HA gene DNA inserted into vector graphic Arrow Baculovirus imported into host cell graphic Arrow Baculovirus imported into host cell graphic Arrow Baculovirus imported into host cell graphic Arrow Baculovirus imported into host cell graphic

This eliminates the possibility of adaptation or mutation during the manufacturing process.2,3

  • According to evidence gathered over previous flu seasons, influenza vaccine effectiveness against A/H3N2 influenza viruses may have been lower than against other influenza strains. This may be due to egg adaptation, resulting in an antigenic mismatch between the vaccine strain and strains circulating during a particular influenza season5–8

CVV, Candidate Vaccine Virus; HA, haemagglutinin; WHO, World Health Organization.



REFERENCES:

  1. Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) Summary of Product Characteristics.
    Sanofi Pasteur [November 2020].
  2. Dunkle LM, et al. N Engl J Med. 2017;376:2427–36.
  3. Centers for Disease Control and Prevention. How influenza (flu) vaccines are made. Available at: https://www.cdc.gov/flu/prevent/how-fluvaccine-made.htm#recombinant [Last accessed October 2020].
  4. Harding AT and Heaton NS. Vaccines. 2018;6:19.
  5. Skowronski DM, et al. PLoS ONE. 2014;9:e92153.
  6. Zost, SJ, et al. Proc Natl Acad Sci USA. 2017;114:12578–83.
  7. Widjaja L, et al. Virology. 2006;350:137–45.
  8. Flannery, B, et al. Morb Mortal Wkly Rep. 2018;67:180–85.




Reporting side effects
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to the Sanofi drug safety department on 0800 0902 314. Alternatively send via email to
UK-drugsafety@sanofi.com


Date of preparation: March 2021 | MAT-GB-2003350(v1.0)