Call for pharma vax info
April 24, 2014
Medecins Sans Frontieres (MSF)
has called on pharmaceutical
companies to publish new
information about when vaccines
can be used outside the cold chain.
The cold chain, or the
requirement to keep vaccines
between 2 and 8°C, meant in
developing countries, the logistics
of transporting vaccines was
a “considerable obstacle” and
the difficulty in getting vaccines
to places was a cause of low
immunisation rates in some
countries, MSF said.
There was growing evidence that
some vaccines could leave the cold
chain for certain periods of time,
called the Controlled Temperature
Chain (CTC), the organisation said.
MSF research arm Epicentre
conducted a study in 2012 and
2013 of the Serum Institute of
India’s tetanus toxoid vaccine in a
CTC at temperatures of up to 40°C
for up to 30 days.
The study compared the vaccine’s
effectiveness in women aged
between 14 to 49 years of age
in Chad, with a total of 2,129
participants.
Two groups of women received
the vaccine, either after being kept
in a strict cold chain, or out of the
cold chain, for up to 30 days.
MSF said the study showed both
groups of women were adequately
protected against tetanus, with
the vaccine in CTC non-inferior
with respect to seroconversion,
Epicentre director of epidemiology
Dr Rebecca Grais said.
She hoped the result would
encourage clear guidelines on
more flexible use of the vaccine in
CTC conditions so more people in
remote areas could be immunised.
“In the immediate term, the
onus is on the pharmaceutical
companies to generate data and
take the initiative with regulatory
bodies so that their vaccines can
be relicensed for use outside of the
strict cold chain.
“Longer-term we want the
next-generation vaccines to be
developed and licenced with
ambitious heat stability targets so
that this problem is avoided from
the outset.”
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