China did approve an Emergency Usage of COVID-19 vaccines. How far is it reasonable?

Varsha Rajesh,

Research Member,

The COVID19.AI Project.


Over the past year since the outbreak of COVID-19, China has been placed under international scrutiny and its measures and policies to curb the virus outbreak has been viewed as controversial. To add to its list of discredits is the recent admittance by the Chinese Government that it has approved emergency usage of COVID-19 vaccines.

While on the surface it may appear to be an optimistic leap during this pandemic, in reality, this is violative of fundamental medical ethics. Despite China legally fortifying its acts, it is violative of international standards and certain universal principles of bioethics which necessitate conduction of clinical trials. Essentially, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. It entails a four-stage process of experimental treatment on a limited sample before a drug can be released to the general public.

There is no international consensus over clinical trials. However, the International Ethical Guidelines for Biomedical Research Involving Human Subjects generally serve as a guiding factor for domestic regulations on this subject matter. In addition, the Declaration of Helsinki, issued by the World Medical Association (WMA) represents the most influential statement of ethical principles for medical research involving human subjects. Both of these non-binding instruments emphasise on the ethical nature of conduction of clinical trials.

Despite the absence of specific international instrument prescribing rules on clinical trials, as per general principles of law and rules of natural justice, a human being is conferred with certain basic human rights which are reaffirmed under tenets of Universal Declaration of Human Rights, 1948. The conduct of clinical trials without informed consent on the prisoners of war in Second World War by Germans led to the birth of Nuremberg Code in 1947 whereby it was declared inhuman to try newer drugs on prisoners of war.

However, some jurisdictions permit the waiving of clinical trials at different stages provided there is an absolute necessity of the drug and is administered to the general public if the invention shows potential to cure without side effects. However, trials are not entirely foregone altogether. For instance, India has previously waived domestic clinical trials for certain drugs authorized in international markets. In 2016, India waived Phase IV of the clinical trial for ‘Dengvaxia’, a dengue vaccine due to an increased number of cases in the country.

Similarly, during this pandemic, many governments have waived Phase IV Clinical trials for all COVID-19 related drugs and treatments owing to immediate necessity. However, China’s step of administering the Sars-Cov-2 vaccine is alarming because of two reasons. First, the government has issued insubstantial information on the efficacy of the vaccine and evidence of its safety. Further, the vaccine has been in circulation within limited groups for a period of time with little to no information on its effects. Secondly, the Chinese Government has taken specific efforts to twist its law eluding basic bioethical standards and is also attempting to introduce it to other countries, potentially exposes a greater mass of people to the risks of this dubious vaccine. The haste to introduce this vaccine only projects China’s intention to aggressively compete in finding a cure to the virus.

 

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