Identifier
Created
Classification
Origin
09MONTERREY397
2009-10-27 23:58:00
UNCLASSIFIED//FOR OFFICIAL USE ONLY
Consulate Monterrey
Cable title:
MONTERREY TEC ANNOUNCES POTENTIALLY GROUNDBREAKING NEW
how-toVZCZCXRO1859 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
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
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