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PP RUEHAG RUEHAST RUEHDA RUEHDBU RUEHDF RUEHFL RUEHIK RUEHKW RUEHLA
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DE RUEHVI #1230/01 2661509
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P 231509Z SEP 09
FM AMEMBASSY VIENNA
TO RUEHC/SECSTATE WASHDC PRIORITY 3359
RUEHPG/AMEMBASSY PRAGUE 1511
INFO RUEHRC/USDA FAS WASHDC 1255
RUEAUSA/DEPT OF HHS WASHDC
RUEHPH/CDC ATLANTA GA
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 
- - - - - - - - - - - - - 
 
¶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 
- - - - - - - - - - - - - - - 
 
¶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 
- - - - - - - - 
 
¶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 
- - - - - - - - - - - - - - - 
 
¶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 
- - - - - - - - - - - - - - - - - - - - - - 
 
¶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 
- - - - 
 
¶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