The
US Food and Drug Administration (FDA) has approved the first human
tests of an experimental Zika virus vaccine, the makers of the drug
announced on Monday.
Called GLS–5700, the
medication will be used in a clinical trial involving 40 healthy people,
and represents the first major step towards ultimately immunising
people against Zika – which was declared a global public health
emergency by the World Health Organisation (WHO) in February.
"We
are proud to have attained the approval to initiate the first Zika
vaccine study in human volunteers," said J. Joseph Kim, president and
CEO of US-based Inovio Pharmaceuticals, which is developing the vaccine
with South Korean partner, GeneOne Life Science. "We plan to dose our
first subjects in the next weeks and expect to report phase 1 interim
results later this year."
GLS–5700 works by stimulating the
body's immune system to defend itself against Zika. Synthetic fragments
of viral DNA are injected into the skin, prompting the immune system's T
cells to generate antibodies to fight the infection.
The news of
the vaccine trial comes two months after the US Centres for Disease
Control and Prevention (CDC) confirmed the causative link between the
infection and birth defects such as microcephaly, and represents the
culmination of an intense nine months of vaccine development, during
which global fears over Zika's spread have only grown.
"As of May
2016, 58 countries and territories reported continuing mosquito-borne
transmission of the Zika virus," said Kim. "[T]he incidences of viral
infection and medical conditions caused by the virus are expanding, not
contracting."
It's worth pointing out that just because GLS–5700
has reached human testing, there's no guarantee it will turn out to
safely immunise people against Zika. The vaccine has been tested
successfully in small and large animal models, but clinical trials in
humans could take several years to demonstrate that the treatment is
safe, and there's no guarantee it will ultimately prove effective or
make it through subsequent testing phases.
But fortunately,
GLS–5700 isn't the only Zika vaccine candidate currently in development.
An Indian company called Bharat Biotech is researching Zika vaccine
development in animals, while French pharmaceutical company Sanofi SA is
expected to begin human trials with one of its drugs later this year.
In
the US, the National Institute of Allergy and Infectious Diseases
(NIAID) says it's expecting to shortly receive FDA approval to trial a
separate vaccine candidate it developed itself, which would mean we
could have two vaccines in human testing in a matter of weeks.
Earlier
in the month, scientists from the University of Texas Medical Centre
published findings on how a protein called interferon-induced protein 3
could help reduce Zika's ability to infect brain cells – although
clinical trials may be a while away for that particular treatment.
Even
though there's a huge amount of hurdles and potential roadblocks facing
all of these vaccine trials, there's reason to have hope.
"Always,
the first vaccine to go into clinical trial is important,"
epidemiologist Anna Durbin from Johns Hopkins University, who is
involved with the NIAID vaccine effort, told Jessica Glenza at The
Guardian.
"It means the FDA has reviewed it, and I'm sure is
formulating questions and getting ready for additional candidates to
submit their investigational drug applications," she added. "It shows
progress and momentum, and we just need to keep momentum going."
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