- Hello Jeff - Well, now...lookie here!
- (CIDRAP News) -- The US government has awarded Novartis
a $487 million contract to help build a plant in North Carolina that the
company says will be capable of producing 150 million doses of cell-based
pandemic influenza vaccine within 6 months after the start of a pandemic.
- Because of the advantages of growing flu vaccines in
cell culture instead of in chicken eggs, the conventional method, the Novartis
facility is expected to increase the US capacity to make pandemic flu vaccine
by 25%, the Department of Health and Human Services (HHS) said in a news
- The facility, which Novartis said is already under construction
in Holly Springs, N.C., also will make prepandemic flu vaccines, HHS said.
The contract calls for HHS and Novartis to share the cost of the facility,
with HHS providing 40% and the company paying 60%.
- "We currently anticipate that by 2012 the site will
provide jobs for more than 300 highly skilled people with the capability
to produce cell-based flu vaccine, prepandemic vaccine and 150 million
doses of pandemic vaccine within six months of the declaration of an influenza
pandemic," said Dr. Andrin Oswald, CEO of Novartis Vaccines and Diagnostics,
in a news release.
- Dr. Robin Robinson, director of HHS's Biomedical Advanced
Research and Development Authority (BARDA), told CIDRAP News that $317
million of the contract is for facility construction and $170 million is
for buying prepandemic and/or seasonal flu vaccines.
- Under the contract, Novartis is to supply "two commercial-scale
lots" of prepandemic vaccine per year for 3 years, according to the
company announcement. Robinson said that could amount to at least 3 million
doses per year and explained that the contract actually provides for either
seasonal or prepandemic cell-based vaccine. The contract also gives HHS
the option to continue buying vaccine for 17 more years.
- Novartis already makes a cell-based seasonal flu vaccine
that was approved by the European Union in May 2008, Robinson noted. He
said the company also has applied to the EU for licensure of a cell-based
H5N1 prepandemic vaccine.
- "This year Novartis will be making a regulatory
submission for [US] licensure of a seasonal influenza vaccine using this
cell-based technology," Robinson said. "It's likely that by the
end of this year or early next year that product will be licensed."
That vaccine will initially be made in Germany, he added.
- HHS awarded Novartis a $220 million contract in May 2006
to speed the development of cell-based flu vaccines. Although the company
announced plans for the North Carolina facility in July 2006, Robinson
said the earlier contract was for development of cell-based flu vaccines,
not for the facility. Most of the vaccine development has been done in
a plant in Marburg, Germany, he said.
- The HHS statement said, "Cell-based vaccine production
could more easily meet surge capacity needs because cells could be frozen
and stored in advance of an epidemic or developed rapidly in response to
an epidemic. Cell-based vaccine production also dramatically reduces the
possibility for contamination and promises to be more reliable, flexible,
and expandable than egg-based methods."
- As noted by HHS, all current US-licensed flu vaccines
are grown in eggs, a method that has changed little since the 1950s. "In
place of eggs, cell-based vaccine production uses laboratory grown cells
that are capable of hosting a growing virus. The virus is injected into
the cells where it multiplies," the agency said. Later the cell walls
are removed and the viruses are harvested, purified, and killed.
- "We believe this is the capstone for the original
plan we set out for pandemic preparedness and medical countermeasures"
and to build up US flu vaccine production capacity, Robinson commented.
- He noted that HHS has a goal of establishing a US capability
to produce 600 million doses of pandemic vaccine within 6 months of the
declaration of a pandemic. Besides Novartis, Sanofi Pasteur and other companies
are also expected to produce pandemic vaccines, he said.
- The new contract also includes about $2 million for clinical
studies to show that vaccines made in the North Carolina facility are comparable
with Novartis vaccines made in Germany, Robinson reported.
- Patricia A. Doyle DVM, PhD Bus Admin, Tropical Agricultural
Economics Univ of West Indies Please visit my "Emerging Diseases"
message board at: http://www.emergingdisease.org/phpbb/index.php Also my
new website: http://drpdoyle.tripod.com/ Zhan le Devlesa tai sastimasa
Go with God and in Good Health