Officials from the Centers for
Disease Control and Prevention (CDC) in USA are in talks with health officials
in Nigeria about the prospects for conducting a phase 1 safety study of the
Ebola vaccine among healthy adults in the country amid mounting anxiety about
the spread of the deadly virus in West Africa, according to the National
Institutes of Health (NIH).
The pace of human safety testing for
experimental Ebola vaccines has been expedited in response to the ongoing virus
outbreak in West Africa which has impacted negatively on businesses in the
three affected countries of Liberia, Sierra Leone and Guinea, with neighbouring
countries closing their borders and banning flights from affected countries to
other parts of Africa.
NIH explained that
“the early-stage
trial will begin initial human testing of a vaccine co-developed by NIAID
[National Institute of Allergy and Infectious Diseases] and GlaxoSmithKline
(GSK) and will evaluate the experimental vaccine’s safety and ability to
generate an immune system response in healthy adults. Testing will take place
at the NIH Clinical Center in Bethesda, Maryland, USA.”
The experimental vaccine is expected
to first be given to three healthy human volunteers to see if they suffer any
adverse effects. If deemed safe, it will then be given to another small group
of volunteers, aged 18 to 50, to see if it produces a strong immune response to
the virus. All will be monitored closely for side effects.
It is understood that the vaccine
will be administered to volunteers by an injection in the deltoid muscle of
their arm, first in a lower dose, then later in a higher dose after the safety
of the vaccine has been determined.
Anthony Fauci, NIAID director,
explained that there is an urgent need for a protective Ebola vaccine, as it is
important to establish that a vaccine is safe and spurs the immune system to
react in a way necessary to protect against infection.
“We know the best way to prevent the
spread of Ebola infection is through public health measures, including good
infection control practices, isolation, contact tracing, quarantine, and
provision of personal protective equipment. However, a vaccine will ultimately
be an important tool in the prevention effort. The launch of phase 1 Ebola
vaccine studies is the first step in a long process.”
Efforts to reach Onyebuchi Chukwu,
the minister of health, to confirm this development via telephone at the time
of filing in this report proved abortive. When BusinessDay reached Dan Nwomeh,
special assistant to the minister of health on media and communications, he
said, “I have no information on that for now”.
Some of the preclinical studies that
are normally done on these types of vaccines were waived by the Food and Drug
Administration (FDA), USA, during the expedited review, Fauci said, so “we want
to take extra special care that we go slowly with the dosing.”
Businessday
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