The H1N1 influenza strain has spread from person to person and country to country and, as expected, the scientific criteria for an influenza pandemic have been met. The WHO has raised the influenza pandemic alert from phase 5 to phase 6, signaling the start of the 2009 influenza pandemic - the first in 40 years.
In apparent lock step with the announcement of Phase 6, and weeks ahead of expectations, Novartis has produced the first ten litre batch of monovalent bulk vaccine. It is derived from the wild-type H1N1 virus that the CDC supplied back in early May. Novartis used cell-culture manufacturing technology instead of the traditional egg-based technology to produce the prototype vaccine , avoiding the delay incurred while having to adapt the wild-type (WT) virus to grow in eggs.
The Novartis produced vaccine is only a prototype because the CDC’s reassortant virus seed (not WT) must be used for routine production of flu vaccine. The reverse genetics reassortant is carefully screened and selected for quality and safety using controlled and documented methods . The wild-type prototype vaccine can however be used for preclinical evaluation’ which may lead to early information on the dose and regimen needed for an H1N1 vaccine. The wild-type prototype vaccine will probably also be tested with an adjuvant to see if a dose sparing effect or a shortened regimen can be achieved. CDC’s Anne Suchart has already stated that they are aware that an H1N1vaccine will require “a lot of antigen to get the response”.
Novartis received the reverse genetics reassortant seed virus from CDC on May 27th, and expects to enter human clinical trials with the resulting vaccine in July, receiving WHO licensure in the fall of 2009. The studies could be completed within 2 months, and licensure could be granted by October, assuming that one and two dose immunization schedules are evaluated and immunogenicity is measured approximately three weeks post second immunization.
Only about 5% of the worldwide flu vaccine capacity employs cell culture technology so Novartis’ early competitive advantage will quickly dissipate as the egg technology vaccines begin to emerge from the likes of Sanofi Pasteur and GSK. Even the majority of Novartis’ capacity is egg technology, based in Siena Italy and Liverpool UK. Their cell-culture facility is in Marburg Germany, while a second facility is under construction in Holly Springs North Carolina. By approximately 2012 the HHS funded Holly Springs facility is anticipated to be capable of producing 150 million doses of pandemic vaccine within six months of the declaration of an influenza pandemic.
Novartis’ cell-culture H1N1 vaccine is a taste of the future. The vast majority of the H1N1 vaccine will be produced in eggs this time around, as discussed in this blog on May 20th. It took 40 years for this pandemic to arrive; cell-culture based flu vaccines should be ubiquitous next time around.
Tags: cell culture, flu, H1N1, HHS, Manufacturing, pandemic, swine, swine flu, Vaccine, WHO
[...] derived from the kidney epithelial cells of African green monkeys. As described in this Blog on June 12th, only about 5% of the worlds current manufacturing capacity is cell-culture based. Baxter [...]
[...] early June, Novartis produced the first batch of monovalent bulk H1N1 vaccine. As discussed in this blog on June 12th, Novartis used cell-culture manufacturing technology instead of the traditional egg-based [...]
[...] cell-line derived from the kidney epithelial cells of African green monkeys. As described in this Blog on June 12th, only about 5% of the world’s current manufacturing capacity is cell-culture based. Baxter [...]