Malaysian Children Used As Guinea Pigs In Vaccine Trial, Endangering Lives, Says Activists
Activists and experts voiced shock, apprehension, and caution about plans to exploit children under the age of 12 as guinea pigs in the third-phase clinical trials of pharmaceutical company Sinovac Biotech Ltd's Covid-19 vaccine.
Experts have urged Putrajaya to gather and reveal more information compiled from the Chinese corporation in order to assist Malaysian parents in making informed choices on behalf of their children, according to The Vibes.
Sharmila Sekaran, the founding chairman of Voice of the Children, raised concerns about the risks of administering the vaccination to children, emphasising that there are unknowns about how the vaccine may affect young children.
“With the Pfizer vaccine, we know boys are at a higher risk of suffering side effects like myocarditis. I think it is a bit of a concern and there needs to be more disclosure and transparency in terms of what the trials are. We don’t know how long-lasting the effects are and the children may continue to suffer side effects or repercussions when they are adults. This needs to be looked into very seriously before any decisions are being made. Parents need to be able to give full and informed consent,” Sharmila said in a statement with The Vibes.
However, Sharmila acknowledged that these clinical trials are required to evaluate the Sinovac vaccine's efficacy and safety before it is injected into the arms of children under the age of 12.
“At some point, these Covid-19 vaccines will have to be experimented on children because they are the target group. The effectiveness of the vaccines may vary depending on communities and ethnic background, so they need to be tested on children who live in Malaysia. There is a possibility that the reality is up to genetics now,” she said.
Dr Sanjay Rampal, a public health medicine specialist and professor of epidemiology at Universiti Malaya's Social and Preventive Medicine Department, shared similar sentiments, applauding the government's plans to conduct such studies.
Dr. Sanjay, on the other hand, stressed the importance of the proposed trial obtaining medical ethics review and approval before it begins.
“It is important for the trial proposal to be reviewed and approved by a medical research ethics committee. The vaccine manufacturer needs to send all relevant documents and prior evidence to prove that the study is ethical. It is then up to the committee to assess the ethics of the proposed study. It’s actually difficult to ascertain the ethical components without all the relevant information”, he said in a statement with The Vibes.
Furthermore, he urged the government to do longer-term effectiveness assessments throughout the experiment, citing the fact that short-term efficacy measures are less relevant for children.
“The objective of the trial should include a prevention of transmission efficacy parameter for newly diagnosed Covid-19.”
Human rights lawyer M. Visvanathan, on the other hand, believes that the government's proposal to conduct such trials on children in this country is not a wise move unless data is available in a fair and transparent manner.
“Normally, what happens in clinical trials for data collection exercise is that you’re basically a guinea pig and there will be waivers of liabilities – that means in the event if something happens to you, the government will not be held liable for any loss, damage, or repercussions as a result of the vaccination exercise. Therefore, before we even advocate for such trials on our own population, there must be data coming from the country of origin,” Visvanathan told The Vibes.
Although he denied that performing clinical trials on children is a violation of the Child’s act, he did acknowledge that the practice may endanger children.
“These are all uncharted territories, we don’t know the implications. We can only charge somebody under the Child’s Act if we know somebody is deliberately endangering the child’s life or something along those lines. In these circumstances, to sign off liability indemnity to indemnify the government for these trials would be, in my opinion, a little reckless,” he added.
Datuk Aaron Ago Dagang, Deputy Health Minister II, told the Dewan Rakyat yesterday that the trials are scheduled to resume at the end of this month.
Aaron said that they would take place at ten research locations, including eight facilities within his ministry, Universiti Malaya, and Universiti Teknologi Mara.
In addition to the vaccine developed by the Chinese business, the Kanowit MP said that another Covid-19 vaccine being studied in the third phase for children is one developed by the United States-based Novavax.
“Several discussion sessions had been held by the Health Ministry with a few vaccine manufacturers to get their latest data on vaccines for those below 12,” Aaron added.
“However, we have yet to receive the data needed from the companies producing the Covid-19 vaccines,” the GPS lawmaker said in response to a question raised by Wong Kah Woh (Ipoh Timur-PH) in the Dewan Rakyat.
Wong had inquired if the government had started to investigate vaccine efficacy in children under the age of 12 and whether any dates had been acquired from vaccine manufacturers regarding when the vaccines might be administered.
Aaron also noted that Pfizer-BioNTech announced the results of their third-phase clinical vaccine trial for children aged 5 to 12 on September 20.
“The vaccine was found to be safe and showed a strong neutralising antibody reaction. On October 15, Pfizer-BioNTech had submitted its findings to the United States Food and Drug Administration and European Medicines Agency,” he said.
Furthermore, Aaron said that China has approved two vaccines developed by Sinovac Biotech and Sinopharm for emergency use on children aged 3 to 17.
“Phases 1 and 2 of clinical trials showed that the vaccines are safe and produced an increased immunity reaction among children and teenagers,” he added.