Globe Biotech’s vaccine trial raises both scientific and ethical concerns
A disturbing news is circulating in the mainstream media regarding Globe Biotech’s desperate effort to find experimental monkeys to test their proposed vaccine candidate. Unfortunately, Globe Biotech recently displayed non-scientific approaches by hunting monkeys in Bhawal National Park and Safari Park in Bangladesh.
According to reports, employees of Globe Biotech Ltd have caught 30 wild monkeys from Safari parks since June 29, 2021. However, the field workers from the company confronted local people while catching monkeys from Barmi Bazar, Gazipur.
It is reported that the company received an approval from the Ministry of Environment, Forests and Climate Change for such inappropriate action. Overall, this naive behaviour jeopardizes future research and ongoing and increasing export of Bangladeshi medicines to foreign countries. Does Globe Biotech understand the well-established regulatory guidelines and standard operating procedures that are in place to conduct preclinical/clinical trials?
Why is preclinical trial in monkeys required for vaccine development?
Preclinical testing using non-human primates (monkey or chimpanzee) is a prerequisite in order to initiate a human clinical trial. There are stringent requirements for using monkeys for vaccine testing to ensure the generation of scientifically valid data as well as to maintain strict ethical standards.
According to the World Health Organization (WHO), the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the Organization for Economic Co-operation and Development (OECD) and other national and international guidelines, maintaining monkeys for preclinical study requires unique laboratory facilities under good laboratory practice (GLP) and extensive training of the personnel involved in testing.
An important aspect of GLP is laboratory and process validation under strict regulatory guidance. Such validation for monkey studies usually requires years of extensive laboratory setup and training of scientists, veterinary pathologists, and more. However, the stark reality is that potentially having no such trained personnel and lab facilities to conduct monkey studies, catching monkeys with the intention of vaccine testing is absolutely unethical and in violation of international guidelines and laws.
Monkey studies are critical to prove that a vaccine candidate is expected to be safe for human use and Globe Biotech’s intention to perform such important studies in every unacceptable way possible shows absolute irresponsibility. This could bring human lives in danger if Globe’s vaccine would receive approval for human clinical trials at the current stage.
We have witnessed that when the US Food and Drug Administration (FDA) issued a temporary pause of Johnson and Johnson Covid-19 vaccine use in the US, Johnson and Johnson, by their own will, immediately stopped shipping their vaccine from the US to Europe to protect human lives from any potential side effects. Globe Biotech’s recent actions indicate their scientific incapability to develop a highly complex innovative vaccine and irresponsibility to protect human lives.
Why is safety an issue for vaccine development?
Vaccines can kill people if safety is not ensured. Unlike any drug, vaccines are usually administered in a large number of healthy people. If anything goes wrong in terms of safety, millions of healthy people may become sick and/or die. This is why international regulatory agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) strictly review and monitor all steps of a vaccine development for ensuring its quality, efficacy, and safety.
In October 2020, we, a group of scientists with relevant scientific and drug development expertise, self-volunteered to evaluate whether Bangovax can qualify for Phase I human trial based on data released by the Globe Biotech (as a preprint).
At that time, this company was asking permission for human trials. We made some recommendations publicly to address how Globe Biotech could test their proposed vaccine candidate to meet the international standards before moving to Phase I human clinical trial:
1. Globe Biotech must perform nonhuman primate studies (monkey or chimpanzee) under strict international GLP requirements to test vaccine safety and efficacy before entering into Phase I clinical trials. As for reference, most of the front-line vaccine candidates against Covid-19 have gone through elaborate and in-depth testing in 2 or 3 higher animal models in order to have solid data on vaccine safety and efficacy.
2. Are all components required for vaccine development (namely mRNA and LNP) manufactured in an internationally certified good manufacturing practice (GMP) facility at Globe Biotech? For instance, production of the vaccine candidate which is injected into animals must fulfill the international GLP and GMP compliance. All of the issues have to be ensured before initiating a human trial.
3. Has Globe established a manufacturing process to consistently produce GMP grade mRNA-LNP with the exact particle size to be injected in humans? Globe has to show GMP-grade and consistent manufacturing process of the vaccine candidate before a clinical trial may be started.
4. Globe Biotech has exaggerated the specificity of their vaccine targeting the D614G mutation. In fact, D614G mutation is outside the receptor binding domain (RBD) and hence doesn't need to be focused in developing a Covid-19 vaccine. Furthermore, although not highlighted by the other vaccine developers due to scientific accuracy, most of the Covid-19 vaccines such as Johnson and Johnson, Moderna, Pfizer, and AstraZeneca ensure protection from SARS-CoV-2 virus having D614G mutation. Therefore, Globe Biotech must refrain from such false scientific statements.
Bangladesh has experienced several waves of Covid-19 infection, but the current delta variant has posed significant threat at every level. The government has shut the whole country completely to save people’s lives. Under these circumstances, Globe Biotech’s move to catch monkeys to perform vaccine trials is totally unacceptable and deserves investigation immediately.
Pharmaceutical industries of Bangladesh have made remarkable progress in manufacturing generic drugs and now these drugs are exported to over 130 countries. Globe Biotech’s action is now known to the international community, thus the reputation of the whole pharma sector is at stake.
Respective authorities including Bangladesh Medical Research Council (BMRC) and Directorate General of Drug Administration must take vaccine safety and ethical issues without utmost reservation, considering human health and future progress of our country.
Dr Rezaul Karim is Manager Regulatory Affairs/Drug Development and Immunologist, Utrecht, The Netherlands. Dr Jubayer Rahman is an Immunologist working at the National Institutes of Health, USA. Dr M Shamsul Alam is an Immunologist working at the National Institutes of Health, USA. Dr Mohammad Sorowar Hossain is Former Senior Manager (R&D), Biotech Division, Incepta Pharmaceutical Ltd; Executive Director, Biomedical Research Foundation, Bangladesh; Associate Professor, Independent University, Bangladesh.