Tuberculosis is a lethal disease that can be fatal, if not treated promptly with the appropriate antibiotic regimen. Recently, 1,500 children in Africa were offered the TB vaccine as part of an experimental trial conducted by Oxford scientists. It was clearly underscored that the vaccine was validated in its safety.

Monkeys became severely unwell after jab

As part of an experiment, several monkeys afflicted by TB were offered the new vaccine. Some of these monkeys became ill because of the jab and had to be offered euthanasia, ultimately. Whilst proponents argue that it can't be demonstrated that the vaccine has definitely engendered death in these monkeys, it is a serious possibility that needs to be contemplated.

However, the number of monkeys included in the study was extremely small. Therefore, no reasonable deduction can be made regarding the effects of the vaccine. Professor Peter Beverly states that these monkeys appeared to "die rather rapidly" following administration of the vaccine.

Families remained uninformed of the outcomes of the monkey trial

The trial has raised ethical issues about the trial conducted, as the children involved in the trial and their families had to participate in the study without being fully aware of the detrimental consequences. It was discovered that the data regarding the unanticipated outcomes of administering the vaccine to the monkeys was not shared.

Information was conferred to families participating in the trial, which stated that the vaccine had been tested previously and was demonstrated to be “safe and effective” in animals. Prof Beverly further expresses that “there is no evidence whatsoever that this is an effective booster vaccine.”

Less casualties by conventional BCG vaccine

In the trial involving monkeys, one group of monkeys was administered the new TB vaccine; while the second was given a BCG vaccine in addition to the new vaccine; and the last group was administered no vaccinations. Bacillus Calmette-Guérin (BCG) has been traditionally used as a form of vaccination against TB as it involves administering a live, attenuated form of Mycobacterium – which therefore primes the immune system to tackle subsequent infections with tuberculosis.

Whilst five out of six monkeys receiving the new vaccine had to be put down, only two monkeys that were administered the BCG vaccine alone died. This suggests a significant difference in safety levels between the two vaccines. Nonetheless, further experimentation is necessary before the new vaccine can be safely implemented on a global scale.

Upholding safety standards at all times 

TB as a condition is particularly prevalent in underprivileged communities, where hygiene and proximity of housing play an important role in contraction and transmission of the disease. As individuals residing in these communities may be especially unfamiliar with the risks and benefits of vaccination – it is imperative to ensure they are provided accurate, complete information that enables them to make a guided decision.

The development of the infants included in the trial took place for up to two years, which was deemed to be a sufficient period to demonstrate the effects of the vaccine. In 2013, when the trial had finished, it was deduced that the vaccine did not offer additional protection against tuberculosis. Prof Beverly lodged a complaint with the university regarding the trial, and an inquiry was initiated which suggested that it “would have been good practice for the potentially adverse reaction observed in the monkey experiment to be reported to the authorities in a more timely fashion.”

Whilst there were some suggestions that information regarding the monkey trial had not been conveyed, the university stated that the relevant information had already been given to the South African regulators. It also went on to state that there were no salient concerns regarding the safety of the vaccine at the point of starting the trial, and it had already been safely employed in animal models. Whether this is a case of miscommunication or clinical negligence, it must be ensured that safety standards are upheld at all times – and patients are duly informed of the risks of any experiment or trial that they partake in. MIMS

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