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Mammalian cell-cultured flu vaccine safe, effective for children and adolescents
Vesikari T. Pediatr Infect Dis J. 2012;doi:10.1097INF.0b013e31824bb179.
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Mammalian cell-cultured influenza vaccine may prove to be a safe and effective alternative to egg-derived influenza vaccine for children and adolescents, according to study results from Finland.
Timo Vesikari, MD, PhD, and colleagues at the Research Center of the University of Tampere Medical School in Finland examined data of 3,604 healthy children divided into two groups: 2,630 were aged 3 to 8 years and 974 were aged 9 to 17 years.
Children were randomly assigned to receive two doses of either cell-culture derived seasonal trivalent influenza vaccine (CCIV; Optaflu, Novartis) or conventional egg-derived trivalent influenza vaccine (TIV). Researchers measured antibody levels and collected data for adverse and serious adverse effects for 7 days after each injection and for the following 6 months.
CCIV was noninferior to TIV for five of six of the immunogenicity measures using cell-derived hemagglutinin (HA) antigens in the hemagglutination inhibition (HI) assay for children in the 3- to 8-year-old age group. For the influenza A/H3N2 strain, the investigators reported that responses to CCIV were noninferior to TIV, as measured by the percentage of study participants who achieved seroconversion, but not for geometric mean titers (GMTs) at day 50.
“Using egg-derived antigen in the HI assay, post-vaccination responses of CCIV vs. TIV were noninferior for two of the six measures. Noninferiority of CCIV to TIV was demonstrated for day 50 GMTs and for the percentage of subjects achieving seroconversion to the A/H1N1 strain, but not to the A/H3N2 and B strains,” the researchers said.
Results for local reactions in the 3- to 8-year-old group were 38% for the cell-cultured group and 35% for TIV after the first vaccination and 35% cell-cultured and 34% TIV after the second. Results for adverse events were similar in both vaccines.
“The results of the present study covering 6 months of follow-up post-vaccination demonstrate that both cell-cultured and TIV were safe and well tolerated in a healthy population (aged) 3 to 17 years, with no difference in local and systematic solicited reactions or in spontaneously reported [adverse events] and [serious adverse events] between cell-derived and egg-derived influenza vaccines in either frequency or severity,” the researchers concluded.
Disclosure: Dr. Vesikari reports receiving research grants from Novartis Vaccines and Diagnostics, manufacturer of Optaflu CCVI.
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The ability to prepare influenza vaccines using cell culture methods provides an alternative to conventional egg grown vaccines. Cell culture methods have many advantages, including scalability, sterility, and the hypothetical advantage of providing a more structurally and antigenically faithful antigen for vaccine usage. In addition, allergy to eggs is not an issue with cell-derived vaccines. Cell culture-derived vaccines have been used in Europe and now the potential exists for such a product to be available in the US.
Both cell-culture and egg-grown vaccines were comparably safe and both were immunogenic. It is hoped that this method of vaccine production will eliminate some of the barriers to rapid production of influenza vaccines.
Kathryn M. Edwards, MD
Infectious Diseases in Children Editorial Board
Disclosure: Dr. Edwards reports no relevant financial disclosures.
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