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 Nicholas Jackson, who heads up the effort, said on Thursday he had
now assembled a team of more than 80 in-house experts who would
start preclinical tests of a potential vaccine in animals this
spring.
The first studies in humans are likely next year, subject to
fast-track clearance from regulators, whose cooperation will be
central in achieving the goal of shaving years off the typical
decade-long process of vaccine development.
Sanofi is chasing rivals such as India's Bharat Biotech, U.S. firm
Inovio and the U.S. National Institutes of Health, which have all
also started Zika vaccine work.
But it has unique capabilities as a major vaccine producer and the
first company in the world to launch a shot for dengue, a related
mosquito-borne disease. It already sells similar established
vaccines for Japanese encephalitis and yellow fever.
Jackson aims to piggy-back on the technology in these products for
Zika, which should speed up development and offer reassurance on
safety, since the basic vaccine "backbone" has already be used
without a problem in millions of patients.
The French group's Sanofi Pasteur vaccine unit also has a big
factory in Lyon capable of producing 100 million doses a year of its
four-strain dengue shot, which could be adapted if needed to make
even more doses of a single-strain Zika product.
"It is our ambition to slash years off the normal timeline required
for a vaccine," Jackson told Reuters.
"Preclinical animal studies will start imminently and we will go
through the various stages of research and development that will
allow us to potentially enter the clinic next year."
In total, the World Health Organization estimates at least 15
companies and academic groups are researching vaccines against Zika,
which has been linked to birth defects and a rare neurological
illness in Brazil and other parts of Latin America.
It is not yet proven that Zika actually causes microcephaly, or
abnormally small heads, in babies or Guillain-Barre syndrome(GBS) in
adults, but evidence of a connection is growing.
Jackson said Sanofi was eager to collaborate with other groups,
since it was important to try different vaccine approaches, and
Sanofi itself plans to test a number of candidates.
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"We may end up with several vaccines that work very well and we are
blessed with a choice," he said.
DIFFERENT AGE GROUPS
On paper, developing a Zika vaccine should be easier than for some
diseases, since the genetic code of the virus is more than 95
percent the same across samples, in contrast to the huge variability
seen, for example, in HIV.
"Because the Zika virus seems to be well-conserved at the genetic
level that greatly improves the chances of success in developing a
vaccine," Jackson said.
Designing clinical trials, however, could be a complicated matter,
since pregnant women are often excluded from such tests until the
safety of new drugs or vaccines is well-established in other
population groups.
One option could be to vaccinate girls before they are sexually
active, as happens with HPV immunization, although the benefits of
this approach would take time to become evident. At the same time,
there may also be a case to protect the broader population against
GBS.
"We need to think about a Zika vaccine that is potentially going to
be given to different age groups," Jackson said.
(Editing by Jane Merriman)
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