[Ip-health] Local production and US bird flu financing

[robert weissman]

To reiterate a point that I think Jamie and others have made on this
list before, the US expenditure on bird flu vaccine capacity was
specifically designed to support the development of capacity within US
borders -- ie, to promote the "local production" about which the US has
complained when prioritized by other countries.

Also, incidentally, the US is providing support to companies to develop
facilities in US borders, but does not intend to demand any price
discounts or other reciprocity in exchange. These firms too may soon be
given immunity from lawsuits.

--
Robert Weissman

[snip]

HHS also has worried that almost all flu vaccines are made outside the
United States. If countries kept vaccine supplies for their own citizens
during a pandemic, vaccines might not be available for Americans.

[snip]

HHS spokeswoman Christina Pearson said each contract was intended to
build domestic capacity for vaccine production, even if some early work
was done overseas.

[snip]

http://www.washingtonpost.com/wp-dyn/content/article/2006/05/04/AR200605040=
0840_pf.html

*US awards $1 billion in flu vaccine contracts*

By Lisa Richwine and Maggie Fox
Reuters
Thursday, May 4, 2006; 6:30 PM

WASHINGTON (Reuters) - Five companies won more than $1 billion in
contracts to develop better influenza vaccines, and to make them largely
on U.S. territory, the U.S. Health and Human Services Department said on
Thursday.

GlaxoSmithKline
<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=3Dbu=
siness&mwpage=3Dqcn&symb=3DGSK&nav=3Del>
Plc (GSK.L) (GSK.N) was awarded $274.75 million, MedImmune Inc.
<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=3Dbu=
siness&mwpage=3Dqcn&symb=3DMEDI&nav=3Del>
(MEDI.O) was awarded $169.46 million, Novartis
<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=3Dbu=
siness&mwpage=3Dqcn&symb=3DNVS&nav=3Del>
AG (NOVN.VX) (NVS.N) won $220.51 million, Computer Sciences Corp.
<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=3Dbu=
siness&mwpage=3Dqcn&symb=3DCSC&nav=3Del>
(CSC.N) unit DynPort Vaccine Co., working with Baxter International Inc.
<http://financial.washingtonpost.com/custom/wpost/html-qcn.asp?dispnav=3Dbu=
siness&mwpage=3Dqcn&symb=3DBAX&nav=3Del>
(BAX.N), won $40.97 million and Solvay Pharmaceuticals (SOLBt.BR) won
$298.59 million.

The companies will work to develop cell based-vaccines against seasonal
influenza or a pandemic strain. The new vaccines will be grown in labs
in batches of cells called cell cultures, HHS Secretary Mike Leavitt said.

The new method aims to replace older systems that require steady
supplies of carefully grown eggs and months of cultivation.

The target is both the annual seasonal flu, and the H5N1 strain
spreading among birds. The H5N1 strain does not easily infect humans,
but it has killed more than 100 people. Experts fear it could mutate
into a form that could spread easily and quickly among people.

If it did, it would spark a pandemic and a rush to make a vaccine to
fight it. Leavitt said the goal is to have vaccine for every American
six months after a pandemic is declared.

"Cell-based vaccine production is more reliable. It's also more flexible
and more scalable than traditional egg-based vaccines," Leavitt said.

Experts have urged the United States for years to help companies
modernize influenza vaccine production. The current, 40-year-old
technology is unwieldy and unreliable, and it takes months to tell how
many doses will be ready in a given year.

HHS also has worried that almost all flu vaccines are made outside the
United States. If countries kept vaccine supplies for their own citizens
during a pandemic, vaccines might not be available for Americans.

Glaxo, MedImmune, Solvay and Novartis said the HHS funding would help
them build or expand manufacturing capacity in the United States.

Baxter said its contract with DynPort covered production of batches of
seasonal or pandemic flu vaccines at a plant in the Czech Republic.
Baxter said it would provide doses of a potential pandemic vaccine to
the U.S. National Institutes of Health for human testing expected to
start this year.

HHS spokeswoman Christina Pearson said each contract was intended to
build domestic capacity for vaccine production, even if some early work
was done overseas.

Maryland-based MedImmune, which makes a needle-free, nasal-spray
vaccine, plans to launch a study in June testing if its technology works
on a potential pandemic strain, Chief Executive David Mott said.

"We plan to expand our domestic manufacturing capacity by establishing a
cell-based facility in the United States that can produce at least 150
million doses within six months of notification of an influenza
pandemic," he added.

Last year, HHS awarded Sanofi Pasteur (SASY.PA) (SNY.N) a $97 million
contract for development of a cell-based vaccine.

Leavitt said he had not yet granted liability protection to the
manufacturers but he said it was likely to happen.

A watchdog group criticized Republican lawmakers for giving the
secretary the power to grant that immunity.

Public Citizen's Congress Watch said in a report that newly obtained
e-mails from the Biotechnology Industry Organization (BIO) showed the
industry was heavily consulted in crafting legislation to allow for
liability protection.

"The lobbyists were totally integrated with the legislative process,"
Public Citizen President Joan Claybrook said, adding it was a "totally
egregious example" of industry power over lawmakers.

BIO representatives had no immediate comment.




Subject:
[Ip-health] US financing of R&D for bird flu
From:
James Love <james.love@cptech.org>
Date:
Fri, 5 May 2006 05:25:08 -0400

To:
Ip-health <ip-health@lists.essential.org>


A billion in US taxpayer money was spent yesterday... Jamie

------------
From: SRosenstein@cfr.org
Subject: Avian Flu Update, May 4, 2006

Dear Friends and Colleagues;

As most of you probably know, the White House released the log-awaited
federal pandemic flu plan yesterday.

[snip]

Though the White House plan leans far less on high technology (drugs
and vaccines) than earlier draft reports, more than half of the $7.1
billion the Administration hopes to spend over the next three years
would be directed to vaccine and drug development. In addition,
Congress in December waived vaccine industry liabilities for flu
products. The combined monetary and liability incentives appear to be
working, as a long list of potential vaccine products are now
surfacing. For example, Vical Inc. this week announced that its cell-
based vaccine technology has proven successful in protecting lab
animals against many flu virus variants =96 all with a single shot.

Yesterday HHS Sec. Mike Leavitt announced that a billion dollars
worth of government contracts to private industry were awarded for
cell-based flu vaccine development:

Company Funding Amount
GlaxoSmithKline $274.75 million
MedImmune $169.46 million
Novartis Vaccines & Diagnostics $220.51 million
DynPort Vaccine $40.97 million
Solvay Pharmaceuticals $298.59 million
Total $1.004 billion

(HHS also awarded Sanofi Pasteur a $97 million contract for
development of a cell-based vaccine in April 2005.


---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks." Bill Walton