VZCZCXRO1859
PP RUEHCD RUEHGD RUEHHO RUEHNG RUEHNL RUEHRD RUEHRS RUEHTM
DE RUEHMC #0397/01 3002358
ZNR UUUUU ZZH
P 272358Z OCT 09
FM AMCONSUL MONTERREY
TO RUEHC/SECSTATE WASHDC PRIORITY 4008
INFO RUEHME/AMEMBASSY MEXICO PRIORITY 5088
RUEHXC/ALL US CONSULATES IN MEXICO COLLECTIVE
RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEHPH/CDC ATLANTA GA PRIORITY 0001
RUEHRC/DEPT OF AGRICULTURE WASHINGTON DC
RUEHOT/AMEMBASSY OTTAWA PRIORITY 0045
RUEHMD/AMEMBASSY MADRID PRIORITY 0011
RUEHMC/AMCONSUL MONTERREY 9626

UNCLAS SECTION 01 OF 02 MONTERREY 000397 
 
SENSITIVE 
SIPDIS 
 
DEPARTMENT PASS OES/IHB 
 
E.O. 12958: N/A 
TAGS: KFLU EAID SOCI TBIO TSPL MCAP MX
SUBJECT: MONTERREY TEC ANNOUNCES POTENTIALLY GROUNDBREAKING NEW 
A/H1N1 INFLUENZA VACCINE 
 
REF: A) MEXICO 3044 
 
MONTERREY 00000397  001.2 OF 002 
 
 
¶1.  (SBU) Summary.  Four days before POTUS' October 23 
declaration of a national emergency in the face of the growing 
influenza pandemic, researchers at Monterrey TEC's FEMSA 
Biotechnology Center announced the development of a new type of 
A/H1N1 influenza vaccine with the potential to solve current 
shortages which have created vulnerabilities in the public 
health systems of both the U.S. and Mexico.  The vaccine has yet 
to undergo human trials, but in an October 23 conversation with 
EconOff, the Monterrey TEC's Dean of Biotechnology said that if 
successful, it could be produced in as early as six to eight 
months.  The Rector of Monterrey TEC states that if the vaccine 
passes clinical trials, the university plans to turn the formula 
over - free of charge - to Mexican private sector vaccine 
manufacturers so that doses can be produced for as low a cost as 
possible.  End summary. 
 
¶2.  (U) On October 19, researchers at Monterrey TEC's FEMSA 
Biotechnology Center announced to local media that researchers 
had developed a novel vaccine for the A/H1N1 influenza virus. 
Researchers described this vaccine as "paradigm breaking" 
because of the unique process by which it can be produced 
rapidly, massively and inexpensively. 
 
¶3.  (SBU) Dr. Manuel Zertuche Guerra, Dean of TEC's Division of 
Biotechnology and Food Engineering, confirmed the media report 
to EconOff on October 23.  He explained that traditional flu 
vaccines are produced by cultivating an influenza virus in the 
yolk of a fertilized chicken egg.  The virus is then extracted 
and chopped into pieces, creating the vaccine.  The FEMSA 
Biotechnology Center's new procedure creates this new vaccine by 
using an innovative - and far less laborious - process which 
uses cell cultures to reproduce the proteins affixed to the 
outside of the virus's shell, instead of the entire virus.  It 
is these proteins which actually trigger the body's autoimmune 
response. 
 
¶4.  (SBU) Zertuche emphasized that while the vaccine has proven 
safe and effective at the molecular and cellular levels, to date 
it has only been tested in animals, and is still undergoing 
trials.  He believes that the center needs two more months to 
prepare the vaccine for submission to Mexico's Federal 
Commission for the Protection against Sanitary Risks (COFEPRIS) 
for approval of human trials.  While stressing that it is very 
difficult to predict a timeline - and emphasizing that in the 
face of a genuine health crises testing and approval might even 
be accelerated - he suggested that 6-8 months from the present 
date was a realistic estimation of the time required to win 
final approval for this vaccine.  If approved, he claims that 
the vaccine could be produced at existing pharmaceutical 
facilities and ready for public distribution within 2-3 weeks. 
Separately, on October 26 Carlos Cruz, Monterrey TEC Rector for 
Innovation and Development, told Consul General that if human 
trials proved successful, the university would make the formula 
available to Mexican vaccine manufacturers free of charge so as 
to speed the production of low-cost vaccines. 
 
Delay in Receipt of Key Authorization 
------------------------------------- 
 
¶5.  (SBU) Zertuche was eager to discuss the FEMSA Biotechnology 
Center's contribution to national and international efforts to 
contain this virus because he believed that, with U.S. and other 
international support, the Center could make a greater 
contribution.  Zertuche said he and his team felt frustrated 
last April when authorities initially declared an epidemic. 
According to him, within 72 hours of that declaration, the U.S. 
Center of Disease Control (CDC) - working with Biogen Idec labs 
in San Diego - delivered to Mexican authorities the "primer," 
the sequence of ribonucleic acid (RNA) used to replicate a 
virus, key in developing a diagnostic tool to identify the 
particular strain of influenza to which the epidemic was 
attributed.  The CDC made the protocol immediately available to 
interested labs.  In order to actually develop a diagnostic 
procedure, the FEMSA Biotechnology Center needed both the primer 
and the protocol.  However, Zertuche said it took the GOM 
approximately one month to verify that his facility had the 
laboratories, equipment, and training necessary to handle the 
primer safely.  "At a critical moment," he noted, "we were not 
ready."  (Comment:  Zertuche admitted that the lab had not been 
accredited when the CDC sent the primer to Mexico.  It is 
accredited now, and he does not anticipate the same problem in 
the case of future epidemics.  End comment.) 
 
MONTERREY 00000397  002.2 OF 002 
 
 
 
Superior Diagnostic Tests 
------------------------- 
 
¶6.  (SBU) Zertuche pointed out that Monterrey TEC's FEMSA 
Biotechnology Center is one of only five Mexican laboratories 
capable of handling diagnostics and research on this kind of 
virus, and one of only two or three currently dedicated to doing 
so.  Since last May, the center has completed more than 800 
diagnostic tests for the A/H1N1 virus.  It has developed several 
primers of its own, which are undergoing tests at St. Jude 
Children's Research Hospital in Tennessee.  Zertuche believes 
that his laboratory's diagnostic processes are both more 
sensitive and economical than those provided by the CDC. 
 
Questionable Statistics, Better Surveillance 
-------------------------------------------- 
 
¶7.  (SBU) Zertuche expressed confidence in GOM statistics 
confirming deaths caused by the A/H1N1 virus, but had less 
confidence in other H1N1 related-statistics, including rates of 
infection.  He observed that current diagnostic tests are 
expensive, and while the test's positive identifications of the 
virus are generally reliable, it has a high incidence of false 
negatives.  The FEMSA Biotechnology Center's Epidemiological 
Vigilance Unit has been working to collect more accurate data: 
since August 30, the unit has tracked over five thousand cases 
of individuals in Metropolitan Monterrey who have generated 
antibodies to the A/H1N1 virus, but display no symptoms. 
 
More Resources, Collaboration Sought 
------------------------------------ 
 
¶8.  (SBU) While Zertuche believes that this information will 
develop a more accurate picture of the virus' prevalence and 
impact, he believes that Mexico should devote resources to a 
dedicated surveillance facility, like that of St. Jude 
Children's Research Hospital, in order to track threatening 
viruses' lethality, mutations and modes of transmission.  He 
added that Monterrey TEC had approached the Pan American Health 
Organization in search of resources to expand the FEMSA 
Biotechnology Center's facilities, and has received a financial 
commitment from the Spanish Government for the same purpose. 
 
¶9.  (SBU) According to Zertuche, his team has a collaborative 
agreement with University of Texas' M.D. Anderson Cancer Center, 
and attorneys are working with St. Jude Children's Research 
Hospital to create the confidentiality agreements required to 
release the kind of detailed information useful to scientific 
colleagues in the U.S.  Dr. Mario Moises Alvarez, Director of 
the FEMSA Biotechnology Center, confirmed in a later 
conversation that his center was negotiating with the Canadian 
Government to form a collaborative agreement with its National 
Microbiology Laboratory as well.  He said that he was 
particularly interested in working with Canadian Light Source, 
Canada's national synchrotron research facility, to analyze the 
structure of the proteins used in creating the A/H1N1 vaccine. 
 
Comment 
------- 
 
¶10.  (SBU) Zertuche is an eloquent advocate for the FEMSA 
Biotechnology Center.  He was particularly passionate in his 
appeal for U.S. support and somewhat guarded in his explanation 
of current research initiatives, in particular regarding details 
about the new vaccine development process.  His reticence was 
most likely due to his desire to guard as yet unpatented trade 
secrets (the FEMSA Biotechnology Center has applied for a 
domestic patent). 
 
¶11.  (SBU) Mexico, like the U.S., currently faces an A/H1N1 
vaccine shortfall.  French pharmaceutical firm Sanofi Pasteur 
has only delivered 10 million of the 30 million doses the GOM 
ordered, due to increased worldwide demand (Reftel A).  Any new 
technique which could exploit current infrastructure to produce 
sufficient vaccine quickly could mitigate a serious risk to 
public health. 
WILLIAMSONB