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New cell-cultured quadrivalent flu vaccine launched

Rachel Soon
Medical Writer
04 Jan 2019

A new cell-cultured quadrivalent influenza vaccine may give Malaysian patients an alternative to those produced with traditional egg-based processes.

First developed in South Korea, NBP607-QIV, known as SKYCellFlu Quadrivalent®, has been indicated for active immunisation for the prevention of influenza caused by influenza virus subtypes A and type B for adults and children above 3 years of age.

Cell-cultured vaccines have been an avenue of interest for seasonal vaccination programs against influenza, as they are faster to produce and generally have higher antigenic similarity to viruses in circulation. In comparison, vaccines traditionally produced using embryonated chicken eggs—a process developed in the 1940s—may develop antigenic modifications to adapt to the egg’s environment, which may alter their efficacy in humans. [Biomed Res Int 2015;doi:10.1155/2015/504831]

Accorsding to Jerome Cabannes, chief operating officer of AJ Biologics, cell-based influenza vaccine manufacture also uses sterile incubators instead of antibiotics or preservatives, which are normally used in egg-based vaccines. This potentially provides a less allergenic alternative for patients who may have sensitivities to egg proteins or to antibiotics.

“On top of that, it will be possible to quickly respond to a new or mutated strain of flu, since the new vaccine can be manufactured within 3 months, as opposed to 6 months or more using the conventional method,” said Cabannes.

Randomized controlled trials of NBP607-QIV in adults and children conducted across several South Korean university hospitals have reported comparable safety profiles and immunogenicity to licensed trivalent egg-based vaccines, with a seroprotection level above 90 percent in children and above 95 percent in adults. [Hum Vaccin Immunother 2017;13(7):1653–1660; Open Forum Infect Dis 2016;3(Suppl 1):763]

“Although manufactured from animal cells, the final product is free from any animal-derived components,” said Dato’ Dr Musa Mohd Nordin, consultant paediatrician and neonatologist, and past president of the Islamic Medical Association of Malaysia (IMAM). “Growing the influenza viruses in cell culture is [also] not dependent on an egg supply.”

Globally, influenza viruses A and B are responsible for seasonal flu epidemics, with currently circulating strains in humans including A/H1N1, A/H3N2, B/Yamagata and B/Victoria. Due to Malaysia’s tropical situation, influenza occurs throughout the year; the most commonly diagnosed cases involve linked to influenza A, of which H1N1 accounts for 22.3 percent, and H3N2 accounts for 14.7 percent.

“Influenza viruses are continually changing, thus resulting in more and more cases each year. To combat this, formulations of flu vaccines are reviewed each year and updated as needed to keep up with the evolving flu viruses,” said Datuk Dr Christopher Lee, senior consultant infectious diseases at Hospital Sungai Buloh. “For the best protection, everyone 6 months and older should get vaccinated annually.”

Speaking at the recent official launch of NBP607-QIV, Lee added that while currently available egg-based vaccines were effective and safe, there was a growing need for their improvement, as issues of waning immunity and antigenic drift could render them less than optimal, especially in older adults.

“Thus, the need for a substantially improved seasonal influenza vaccine is a high-priority and presently an unmet health need,” said Lee.

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