Cablegate: H1n1: Inside Scoop From Baxter On Vaccination

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FM AMEMBASSY VIENNA
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RUEHZL/EUROPEAN POLITICAL COLLECTIVE

UNCLAS SECTION 01 OF 02 VIENNA 001230

SIPDIS, SENSITIVE

DEPT FOR EUR/CE, OES/IHB, and AID/GH/HIDN
HHS FOR OGHA
HHS PASS TO CDC

E.O. 12958: N/A
TAGS: TBIO KFLU KFLO CASC PREL AU EZ
SUBJECT: H1N1: Inside Scoop from Baxter on Vaccination

REF: (A) VIENNA 989; (B) VIENNA 891; (C) VIENNA 733; (D) VIENNA 519

Sensitive but unclassified -- contains business-proprietary
information.

1. (U) SUMMARY: Baxter BioSciences (a large U.S. pharma firm, active
in central Europe) characterizes Austria as one of the best prepared
countries in Europe to deal with a pandemic flu. With only 361
mostly mild cases of H1N1 and no deaths to date, Austria has not put
its plan into action. The GoA is quite sanguine about the upcoming
flu season, and is moving ahead methodically with plans to vaccinate
its high-risk populations with the Baxter vaccine starting in
mid-October. With the Austrian front quiet (so far), Baxter
executives provided insights into H1N1 vaccination issues in other
European countries. END SUMMARY

As Much as Austria Wants
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2. (U) Emboffs met September 18 with executives from Baxter
Biosciences, a U.S. multinational and the sole source for Austria's
H1N1 vaccine. Baxter expects to receive European Medicines Agency
(EMEA) approval of its H1N1 vaccine this week (under the brand name
"Celvapan") and said that the GoA can obtain as much of that vaccine
as it wants. The GoA has already pre-purchased 1 million doses of
the Baxter vaccine and has an option to purchase up to 15 million
more doses (for a population of 8.2 million). The GoA plans to
begin vaccinating high-risk groups in mid-October: however, most
Austrians do not opt to receive even the seasonal flu vaccine (only
10-12% are typically vaccinated, compared to about 40% in the US),
and Baxter foresees some reluctance in the public about getting
vaccinated due to worries about H1N1 vaccine safety. If H1N1 cases
in Austria continue to be few and mild, Baxter expects the GoA to
forego its option on most of the 16 million doses.

Liability Angle: 1 vs 2 doses
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3. (SBU) Due to the nature of the EU's H1N1 approval process,
Baxter's Celvapan H1N1 vaccine will be licensed for a two-dose
approach -- even if one dose would provide "adequate" immunity from
a public health perspective. Baxter marketing director Cornelia
Kutzer pointed out that this could create an interesting liability
situation for health ministries: delivering just one dose per
patient may be a sensible policy (given the limited supply of
vaccine), but that would leave regulators at variance with two-dose
manufacturer labeling. So far, however, Baxter had "no data on
national attitudes" on whether European countries will use a one- or
two-dose approach.

Pregnancy Twist
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4. (U) While Baxter is no longer taking on additional H1N1
contracts, Kutzer reported that the GoA has been approached by
several other European governments, including Germany, with interest
in obtaining doses of Baxter's H1N1 vaccine to cover pregnant
citizens. Baxter's vaccine is somewhat unique in that it uses
neither an adjuvant (to stimulate the immune response) nor a
preservative (which has trace amounts of mercury) making it more
acceptable to cautious pregnancy patients. Thus, GoA might use its
option with Baxter to buy additional vaccine to help fellow EU
member states.

Baxter Supply, Demand Issues
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5. (U) Baxter Vice President for R&D Vaccines Noel Barrett announced
that Baxter had improved its vaccine output three-fold since August
but wouldn't say whether it had reached the original production goal
of 2 million doses per week. Baxter is no longer taking additional
orders, but the company is still receiving requests from governments
in the Middle East and Southeast Asia. He also mentioned that
Baxter has committed to donating a certain share of its production
to the World Health Organization (he could not say how much), but
probably not until 2010.

6. (SBU) Barrett cited complications associated with the company's
production facility at Bohumil in the Czech Republic (NOTE: Baxter
does the R&D and final packaging of vaccines in Vienna, but actual
vaccine production is in Bohumil). He said that Czech authorities
had voiced "subtle threats" to nationalize Baxter's Bohumil
facility, but opined that this was more of a negotiating tactic than
a serious possibility. (NOTE: We understand that Baxter and Czech
authorities met repeatedly about a H1N1 vaccine purchase, but were

VIENNA 00001230 002 OF 002

unable to reach agreement and the Czech government ultimately
procured from competitor GlaxoSmithKline - END NOTE).

Austrian Government View of H1N1 Situation
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7. (U) As of September 18, Austrian authorities reported 361
cumulative H1N1 cases since the outbreak of the epidemic. Only 31
mostly mild cases have been reported since the school year began in
early September. Most infected persons are travelers, and 90% are
between 20 and 39 years old. There is no longer hospitalization of
non-severe H1N1 cases after registration; the GoA will not implement
emergency measures such as heat imaging of airport passengers and is
merely publicizing simple precautions (such as hand-washing).
Barrett praised the preparation and awareness campaign by Public
Health Director Hubert Hrabcik, whose calm approach has helped ease
public worries about the disease.

8. (U) An aide to Hrabcik told the Embassy that the Ministry of
Health is still preparing for an outbreak of the pandemic on the
basis of Austria's comprehensive "Pandemic Preparedness Plan" from
2005, but said there is no/no need for emergency measures since
Austrian cases are still well below the European average. GoA
vaccination efforts will target health care personnel, pharmacists,
police, pregnant women, and people with chronic diseases. Our
contact expected that Baxter can only deliver 300,000 doses of its
vaccine in the first phase and later 70,000 to 100,000 doses per
week. The vaccine will be offered for the regular "prescription
fee" for all medicines in Austria (EUR 4.90).

COMMENT
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9. (SBU) While the Austrian government and Baxter are very well
prepared to vaccinate Austrians against H1N1, one concern is that
the low incidence so far (fewer than 400 cases, with no deaths) may
be lulling Austrians into a misplaced sense of security. That
attitude, combined with a widespread aversion to seasonal flu shots,
could ultimately result in Austrian authorities "playing catch up"
with an under-vaccinated public. END COMMENT.

EACHO

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