Clinical trials are often used by scientists to test new methods of
diagnosing, treating or preventing diseases. FILE PHOTO | NMG
To effectively tackle the coronavirus disease, which has caused
havoc to nations world over by crippling economies and health systems,
scientists have been working round the clock to develop a
suitable vaccine for the condition.
suitable vaccine for the condition.
In this journey, many of the
potential vaccines have not made it that far. But there is finally
light at the end of the tunnel, based on new findings published in the
“Lancet” journal.
The
research, which focused on the first Covid-19 vaccine to reach phase
one clinical trials, found that the vaccine was safe and well tolerated
in human beings.
Most importantly, the researchers
discovered that the vaccine was able to generate an immune response
against the virus that causes Covid-19, which is known as SARS-CoV-2.
Clinical
trials are often used by scientists to test new methods of diagnosing,
treating or preventing diseases (such as Covid-19).
The goal is to determine whether a novel product is both safe and effective in human beings.
Before
people are exposed to a potential vaccine in clinical trials, it is
first tested in small samples of human cells (not people) or animals in
laboratories.
During this period, the researchers
assess the effects of a vaccine to find out if it is toxic or whether it
has the potential of harming human beings.
If the
results at this stage are promising, the vaccine is allowed to move to
Phase One trials. It is at this stage that the vaccine is tested in
people for the first time.
Previous
potential Covid-19 vaccines did not make it past the preliminary
research stages and could not therefore be tested in people.
Yet, the creation of an effective vaccine is seen as the long-term solution to controlling the pandemic.
In
this regard, the new vaccine analysed in the “Lancet” study – known as
the adenovirus type 5 vectored Covid-19 (Ad5-nCoV) - represents a
milestone in the search for a vaccine against the coronavirus disease
that has no cure.
“The new vaccine evaluated in this
trial is the first to be tested in humans. This represents an important
milestone,” stated the researchers.
Indeed, the results
of the study demonstrated that a single dose of the vaccine produces
antibodies against the virus that causes Covid-19 in 14 days.
This
makes it a potential vaccine candidate for further investigation,” said
Prof Wei Chen, the lead author of the study from the Beijing Institute
of Biotechnology in China.
He however noted that the
results of the study should be interpreted cautiously as further studies
are still required before the vaccine can be approved.
“The
challenges in the development of a Covid-19 vaccine are unprecedented,
and the ability to trigger these immune responses does not necessarily
indicate that the vaccine will protect humans from Covid-19.
This
result shows a promising vision for the development of Covid-19
vaccines, but we are still a long way from this vaccine being available
to all."
The research was conducted among 108 healthy adults between the ages of 18 and 60 years who did not have Covid-19.
Volunteers
participating in the study were enrolled from one site in Wuhan, China.
They were divided into three groups that received a low, medium or high
dose of the candidate vaccine.
The results of the
study, following blood tests conducted at regular intervals among
volunteers, showed that the vaccine was able to stimulate the body’s
immune system against the SARS-CoV-2 virus that causes the Covid-19
disease. Most people developed a type of antibody that can attach to the
virus, though not necessarily destroy it. Some also developed the
so-called neutralising antibodies, which can block the virus.
The
concentration of neutralising antibodies, which researchers believe is
important in acquiring protection against the virus, appeared to
increase with dose strength.
Indeed,
within 28 days, 75 percent of patients that received a high dose of the
vaccine were found to have neutralising antibodies compared to 50
percent of the volunteers that got a low or moderate dose of the
vaccine.
The vaccine candidate was also well tolerated
at all doses, with no serious adverse effects reported within 28 days of
vaccination.
The few effects that were reported were
mild and moderate. They included pain at the injection point, fever,
headache and muscle pain.
One participant that had been
given the higher dose vaccine reported severe fever along with severe
symptoms of fatigue, shortness of breath, and muscle pain. However,
these adverse reactions persisted for less than 48 hours.
With
the success of the phase one trial, the researchers have already
initiated a Phase Two trial in Wuhan to further test the safety and
efficacy of the vaccine.
This research will determine
whether the results of the phase one trial can be replicated in a larger
group of people. It will involve 500 healthy adult volunteers,
including participants over 60 years old, who are an important target
population for the vaccine.
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