Rather than rely on poultry and the eggs they produce for the manufacture of yearly flu vaccines, the World Health Organization (WHO) and FDA have encouraged vaccine manufacturers to look to other manufacturing technologies, such as use of a cell-based production model. Seqirus announced on June 21, 2017 that it has successfully used such a model for the large-scale production of the flu vaccine using a cell-derived H3N2 candidate vaccine virus that was originally procured from the National Influenza Center in Singapore.
This development is especially timely, considering the Government Accountability Organization (GAO) just released a report in May 2017 asserting that the U.S. government only has one “dependable manufacturer for producing egg-based vaccine for rapid pandemic mitigation.” Disease affecting poultry and their eggs, such as the avian flu, can drastically reduce the ability of a manufacturer to produce an adequate quantity of vaccine in the face of a pandemic threat.
The GAO report also said that the Department of Health and Human Services (HHS) “has an obligation under the National Strategy for Pandemic Influenza to promote capabilities that assure a pandemic vaccine can be produced at a U.S.-licensed influenza vaccine facility at any time of the year, without limitations imposed by the availability of essential supplies.”
Approximately 90% to 95% of the current national stockpile of pandemic flu vaccines is derived from eggs, according to the GAO report, and only four companies in the world are capable of producing enough flu vaccine. Of those four companies, notes the report, “only one has an egg-based vaccine manufacturing facility in the United States.”
While vaccines can be made in kidney cells of monkeys or canines through traditional cell culture technologies, they can also be made in other cells such as bacteria, yeast, insects, or plants via recombinant technology. Seqirus’ Holly Springs, North Carolina facility uses mammalian cells to produce the flu vaccine, which a company spokesperson told GEN is the only facility in the U.S. to do so. In total, Seqirus operates three major influenza vaccine manufacturing sites: The Holly Springs site (which harnesses cell-culture technology); one in Liverpool, United Kingdom; and another in Melbourne, Australia. The Melbourne and Liverpool facilities utilize egg-based manufacturing technology.
While the HHS is trying to diversify its vaccine supply sources, and has set up three Centers for Innovation in Advanced Development and Manufacturing in Maryland, North Carolina, and Texas in anticipation of a pandemic outbreak—none of the centers were open or functional as of February 2017, according to the GAO report.
Besides issues with egg supply, producing vaccines in eggs comes with other challenges. Seqirus told GEN that not all influenza viruses grow well in eggs, which can lead to changes in vaccine virus. “The use of cell-based technology for the production of influenza vaccines represents one of the most significant advances in the history of influenza vaccine production. It is a flexible, highly scalable alternative to egg-based manufacturing, with the potential to quickly ramp up production in the event of pandemic,” the company representative noted. Using a non-egg-based model, Seqirus says, will increase the speed and output of vaccine production.
The production of the Seqirus vaccine occurred in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA), and involved collaboration with WHO’s Collaborating Center for Surveillance, Epidemiology, and Control of Influenza at the U.S. CDC and at a similar WHO branch in Australia. Seqirus is currently the second-largest flu vaccine provider in the world, trumped only by Sanofi Pasteur. Flucelvax is the brand name of the cell-based vaccine manufactured by Seqirus, and the company says it expects to ship its portfolio of influenza vaccines to the U.S. market in July 2017.
