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Update: HIV vaccine
HIV vaccine trials are due to start soon. But when? Dr Andrew Robinson,
Director of the MRC's HIV Vaccine Research Unit, provides an update on timelines
in the vaccine development process.
Much has been said or 'quoted' in the media over the last few years as to
when the first South African AIDS vaccine trial will start and when will the
vaccine be registered for general use. Let me update you.
The vaccine development team is acutely aware of the extreme urgency of their
task to deliver a safe, affordable, effective and locally relevant preventative
vaccine to the southern African region. All possible networks, agreements,
planning, budgeting and lobbying are geared to deliver a vaccine in the shortest
possible time. All clinical trials are by law subject to review and approval by
statutory regulatory bodies such as the Medicines Control Council (MCC) in South
African and the US Food and Drug Administration (FDA).
In addition, Ethics Committees or their US counterparts, Independent Review
Boards (IRBS), are also required to review and approve clinical trials. This
review process must be thorough and therefore does take time for very good
reason.
The Venezuelan Equine Encephalitis (VEE) vaccine trial still awaits final
approval from the MCC and the FDA.
Quality counts
Vaccines, unlike medicines that are made from inert substances or chemicals,
are made from living organisms, i.e. they are grown. That is why each vaccine,
such as the measles, polio, flu and clinical trial vaccines are made in batches
to enable quality control of the highest possible standards.
One of the VEE clinical vaccine batches did not meet the stringent quality
control checks. This has delayed the trial starting as all batches were
withdrawn so that new batches of VEE vaccine can be grown which will meet the
required standards. With 'cutting edge' science, using novel and complicated
processes, it is not surprising that difficulties are encountered during the
manufacturing process. It is fortunate that the quality control issue was
detected before the trial started.
So with the above in mind, we will only start the vaccine clinical trial once
all the pre-trial requirements are met. Similarly, the vaccine licencing for
general use will only happen once all three trial phases are complete and the
vaccine has been shown to be safe and effective on review by the appropriate
regulatory authorities, e.g. the MCC.
When?
If one likens the process to that of a tree growing: the best time to plant a
tree is 20 years ago, so one would have immediate benefits of the shade, fruit,
beauty or timber. Likewise with the HIV preventative vaccine, we would like to
have begun 20 years ago but, failing that, the best time is to start now. So,
for timelines on the highly complex and exciting path of HIV vaccine discovery,
I will hazard a guess: HIV vaccine trials will get under way in South Africa
within months, while registration and licensing will take years, possibly ten or
so. In the history of vaccine development, such as that for smallpox, polio,
measles, and the like, this timescale is quick, very quick.
As this is a highly dynamic process with issues and obstacles coming and
going on a daily basis, the best way to find out about the when of HIV vaccines,
is to open and maintain effective channels of communication, such as the MRC
KwaZulu-Natal AIDS Forum, so researchers can act in a transparent fashion,
informing South Africans of all aspects of HIV vaccine development so that
reasonable expectations can be set.
All possible networks, agreements, planning, budgeting and lobbying are
geared to deliver a vaccine in the shortest possible time.
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