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Robert Sievers, Ph.D., who leads the team that developed the
dry-powder vaccine, said it’s a perfect fit for use in back-roads areas
of developing countries. Those areas often lack the electricity for
refrigeration, clean water and sterile needles needed to administer
traditional liquid vaccines.
“Childhood vaccines that can be inhaled and delivered directly to
mucosal surfaces have the potential to offer significant advantages
over injection,” Sievers said. “Not only might they reduce the risk of
infection from HIV, hepatitis, and other serious diseases due to
unsterilized needles, they may prove more effective against disease.”
“Many serious infections, such as the measles virus, can enter the
body through inhalation. Measles vaccine dry powders have the potential
to effectively vaccinate infants, children and adults by inhalation,
avoiding the problems associated with liquid vaccines delivered by
injection,” he added.
Although made for developing countries, the technology eventually
could become the basis for a new generation of inhalable — and ouchless
vaccines — in the United States and elsewhere. So far, an inhalable
vaccine is available for only one disease. It is a wet mist vaccine for
Sievers, once an atmospheric scientist and who now is with
Department of Chemistry and Biochemistry and Center for Pharmaceutical
Biotechnology, University of Colorado, Boulder, took inspiration for
the new vaccine from research on how people inhale tiny airborne
droplets of air pollutants.
To create an inhalable vaccine, Sievers and his team of students and
researchers developed a patented process known as the "Carbon
Dioxide-Assisted Nebulization with a Bubble Dryer," called CAN-BD. The
weakened measles virus is mixed with "supercritical" carbon dioxide —
part gas, part liquid — to produce microscopic bubbles and droplets,
which then are dried to make an inhalable powder.
The powder is puffed into a small, cylindrical, plastic sack, with
an opening like the neck of a plastic water bottle, and administered.
“By taking one deep breath from the sack, a child could be effectively
vaccinated,” Sievers said.
In animal tests, the inhaler has been just as effective in
delivering measles vaccine as the traditional injection, the
researchers say. They now are working on an inexpensive dry powder
inhaler that would deliver measles or influenza vaccines to developing
nations and could be used elsewhere. In replacing injections, the new
method also would help reach those who refuse inoculations because of
their fear of needles. The researchers say that the vaccine could be
produced for about 26 cents a dose.
If the inhaler passes final safety and effectiveness tests, the
Serum Institute of India Ltd. expects a demand growing to 400 million
doses of measles vaccine a year, according to Sievers.
“Human clinical trials are expected to begin next year in India,
after animal safety studies are completed this year,” Sievers said.
“About two-thirds of the world’s deaths due to measles occur in that
nation. Worldwide, several hundred people die every day from
measles-related disease,” he added.
In earlier research in the 1980s in Mexico during a measles
outbreak, 3 million children received a measles vaccine by inhaling a
wet mist aerosol and those who took part in the test had a lower rate
of developing measles than those who received a vaccine by injection,
according to Sievers. “The problem with that method,” he said, “was
that the wet mists required power or batteries to generate the aerosol
and the liquid vaccines had to be freshly made up and kept on ice and
the nebulizer that delivers the dose had to be cleaned. The new,
inexpensive dry aerosol dispenser doesn’t need to be cleaned and
doesn’t require power,” he said.
The study has been conducted with a grant from the Foundation for
the National Institutes of Health as part of the Grand Challenges in
Global Health Initiative of the Bill and Melinda Gates Foundation.
-- News release courtesy of American Chemical Society
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