- The use of ivermectin for either the prevention or
treatment of Covid-19 is unjustified, risky and unethical.
- According to the Ministerial Advisory Committee on
Covid-19, it is not registered for human use and there is no scientific
evidence that it is effective.
- Ivermectin is also associated with a range of
adverse effects when used in humans.
Until more robust evidence is available, the
routine use of ivermectin for either the prevention or treatment of Covid-19 is
not justified. In addition, the use of unregulated products purporting to
contain ivermectin is risky and unethical.
This, according to a memo from the Ministerial
Advisory Committee (MAC) on Covid-19, sent to Health Minister Zweli Mkhize on 7
The memo is signed by MAC co-chairs professors
Salim Abdool Karim and Marian Jacobs.
Ivermectin, a parasiticide, has been getting attention as a possible
Covid-19 treatment, Health24 reported.
The drug works by paralysing and killing parasites in
animals, notes the South African Health Products Regulatory
In South Africa, ivermectin is registered for use
in animals, allowing veterinarians and other trained personnel to prescribe it
as an antiparasitic agent for a variety of animals.
However, it is not currently registered for human
use, although Sahpra stated it had occasionally granted permits for its use as
treatment for individuals with conditions such as scabies or head lice.
According to the MAC’s memo, the use of ivermectin
for the treatment or prevention of Covid-19 has generated significant global
“The use of this repurposed medicine is being
heavily promoted via social media. However, given the limited evidence of
efficacy and safety, as well as appropriate dosing of ivermectin, its place in
therapy and prophylaxis remains uncertain at this point,” the memo states.
Grasping at any option
“…motivated by concern for their patients,
clinicians are grasping at any option which promises positive results.
Ivermectin is being portrayed, despite the lack of high-quality evidence, as
one such option. It has therefore been observed that unregulated use of
ivermectin is evident in South Africa and increasing.”
The MAC warned that no ivermectin-containing
medicine for human use is registered in South Africa, and that there had been
no applications for clinical trials involving ivermectin, nor for the
registration of any ivermectin-containing medicine for the treatment or
prevention of Covid-19.
Using medicines not approved by Sahpra is illegal.
At least one political party, the National Freedom
Party (NFP), as well as a collective of scientists and activists who call
themselves the Ivermectin Interest Group, have called for the drug to be made
available, City Press reported.
The NFP has gone as far as threatening to take
Health Minister Zweli Mkhize to court to demand an urgent meeting with him for
the country to begin testing it and using it.
READ Health experts at odds on use of
drug to treat Covid
Ivermectin has been gaining traction as a
“wonder drug”, as some medical experts reportedly have suggested that
the drug inhibits viral loads and keeps those with early symptoms of the
disease from progressing to the hyper-inflammatory phase.
But while there are numerous anecdotal reports from
general practitioners and pharmacists of the widespread prescribing and sale of
ivermectin for these purposes, “no meaningful clinical data can be
collected from this type of unregulated, off-label use,” the MAC said.
“The vast majority of patients with Covid-19
will recover without specific pharmacological treatment.”
Insufficient data to justify safe use
The MAC said there is “some in vitro
evidence” that ivermectin has antiviral activity against SARS-CoV-2, the
virus that causes Covid-19.
Other host-directed effects may also be possible. Ivermectin has been used, at various doses and in combination with other medicines, in a number of clinical studies, both observational and randomised.
But, it said, the currently available data have
been reviewed by the National Essential Medicines Committee Covid-19
Subcommittee and Sahpra and are considered “insufficient to justify safe
use in clinical practice at this point”.
According to the memo, the Access to Covid-19 Tools
(ACT) Accelerator has also commissioned a systematic review and meta-analysis
of the available clinical trials evidence, but that process has yet to be
“More data are required from adequately
powered, well-designed randomised clinical trials to demonstrate the efficacy
and safety of ivermectin in both treatment and prevention of Covid-19. Some
larger trials are ongoing, and it is hoped that the results will become
available within the first quarter of 2021,” the MAC said.
Adverse effects in humans
“There have been reports of apparent toxicity
from overdoses of ivermectin. Although portrayed as safe, ivermectin is
associated with a range of adverse effects when used in its registered
indications in humans.”
The MAC added that it was concerned about reports
of profiteering from the sale of unlicensed products which purport to contain
“Prices as high as R500 per tablet have been
reported. There is also anecdotal evidence that ivermectin is distributed for
free in KwaZulu-Natal. Sahpra is investigating complaints of unregulated sale
and use of ivermectin products.”
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in alleged possession of ivermectin tablets valued at R100 000
Having reviewed the data, the MAC found that
“there is insufficient evidence at this stage to support the routine use
of ivermectin for either the prevention or treatment of Covid-19”.
“The overall quality of randomised controlled
clinical trials of ivermectin in the treatment of Covid-19 patient is poor and
the existing trials are underpowered and poorly designed,” it noted. A
final report of a systematic review and meta-analysis is expected to be
released in this week.
Fast-tracking controlled trial
Sahpra has indicated that it would welcome and
fast-track an application for a randomised controlled trial.
The MAC said the rapid review of the available
evidence conducted by the National Essential Medicines List Committee (NEMLC)
Covid-19 subcommittee suggested that ivermectin not be used for the treatment
of patients with Covid-19, as the evidence of efficacy and safety is uncertain
at this point.
The NEMLC is actively reviewing all available
evidence and will continue to review emerging evidence from clinical trials
that are ongoing. As of December 2020, there were 37 trials registered on
Clinicaltrials.gov, it added.
Emerging evidence must be actively sought and carefully reviewed. Reports of clinical trials of ivermectin for the prevention or treatment of Covid-19 must be closely watched, as they become available. As always, reports in peer-reviewed publications will be preferred.
However, at present, “unregulated distribution
channels are at risk of the introduction of sub-standard and falsified
products, which can be deleterious to human health”, it said.
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