Vaccine manufacturers in $1bn bird flu bonanza
(€780m) to five drug companies to develop and produce cell-based
vaccines to fight influenza, in preparation for a possible bird flu
pandemic.
The funding comes from $3.3bn American lawmakers approved last year to address the issue, with the administration aiming to have 600 million flu vaccine doses available within six months of a pandemic, one for every American.
To meet this target, the US Health and Human Services Department (HHS) is looking to diversify the production of influenza vaccines by using cell-based vaccine manufacturing, and also to have more of such manufacturing take place in American territory.
The government hopes the advance of new cell-based technologies will replace egg-based methods, which have changed little in over 50 years and require steady supplies of carefully grown eggs and months of cultivation.
The most expensive contract to develop cell-based influenza vaccines and plan for domestic manufacturing capacity in the US was clinched by Solvay Pharmaceuticals for $298m.
The money will allow the Belgian company to develop a master plan to manufacture, formulate, fill and package annual and pandemic influenza vaccines in a new US-based facility which has yet to be identified, as well as submit an Investigational New Drug (IND) application, pre-clinical and clinical studies for seasonal and pandemic-like vaccines, adjuvant development and a Biologics License Application (BLA) allowing for the distribution and marketing of influenza vaccines in the US.
"We expect the new vaccine production unit to be operational by 2011 and make some 150m monovalent doses per year," Solvay spokesman Martial Tardy told In-PharmaTechnologist.com.
"Solvay has specific experience in the manufacturing of flu vaccines and our cell-derived influenza vaccine was approved by the Dutch authorities in 2001."
The company said its cell-based influenza vaccine manufacturing facility in the Netherlands will provide a strong foundation for the development of a similar facility in the US.
GlaxoSmithKline (GSK) received $274m which will be used in R&D and to scale-up cell culture manufacturing capability at its Marietta facility in Pennsylvania, where the firm said it will continue to make an investment in excess of $100m.
Within the five-year contract period, GSK will undertake clinical programs to support filing of a BLA for a cell culture-based trivalent seasonal influenza vaccine and to complete Phase II studies of an H5N1 cell culture-based pandemic influenza vaccine.
Swiss drugmaker Novartis was granted $220m for cell culture-derived influenza vaccine development as well as facility and equipment design and validation.
MedImmune, on the other hand, will use the $170m it got to develop cell-based seasonal and pandemic vaccines using its live, attenuated, needle-free influenza vaccine technology.
CAIV-T, the Maryland-based company's investigational intranasal, cold-adapted trivalent influenza vaccine, is currently in Phase III trials.
Finally, DynPort Vaccine, a specialist biodefense company working with Baxter International, was awarded $41m until July 2007, at which stage the HSS will decide on whether to award a further $201m.
DynPort would not comment on which specific criteria this decision will be based on, revealing only that "performance and technology will be assessed."
Its partner Baxter will develop seasonal and pandemic vaccines using its vero-cell technology and will manufacture them at the company's production facility in the Czech Republic.
With these agreements the US government is looking to ramp up capacity in flu vaccines, since by using cell-based technologies vaccine manufacturers will be able to bypass the steps needed to adapt the virus strains to grow in eggs, freezing cells in advance and producing large volumes grown quickly.
Current egg-derived vaccines production requires several months of logistics for ordering and receiving eggs whereas flu cell culture production is independent of the availability of eggs.
Moreover, the new cell-based influenza vaccines will provide an option for people who are allergic to eggs and therefore unable to receive the currently licensed vaccines.
Last year, the HHS awarded Sanofi Pasteur a $97m contract for development of a cell-based vaccine.
