Dubai: During the peak of the pandemic, G42 Healthcare, a home-grown, Abu Dhabi-based company, facilitated the 4Humanity project that involved the world’s first ever Phase III clinical trials of a deactivated vaccine against COVID-19 - Sinopharm. Over 43,000 volunteers participated in the pan-Arab Phase III trial from over 125 nationalities. This actually set the stage for the rollout of the vaccine in the community. The World Health Organisation (WHO) granted it approval for emergency use last month.
As the Arab Health Congress 2021 begins, Gulf News spoke to Dr Walid Zaher, Chief Research Officer and Vaccine Project Leader at G42, to gain an insight into his experience of managing the historic Phase III clinical trials of Sinopharm. Prior to joining G42, Dr Zaher was Corporate Group Clinical Research and Innovation Director at the Abu Dhabi Health Services Company (Seha).
Besides showcasing the logistics involved in 4Humanity Phase III clinical trial of Sinopharm, Dr Zaher spoke on a range of new projects:
Gulf News: Could you share the role G42 played in Phase III Sinopharm vaccine trials?
Dr Walid Zaher: The UAE was quick to take the lead in the global fight against COVID-19 and G42 Healthcare has been at the forefront of this battle, focused on finding the right solutions. To support the UAE government, G42 stepped up to facilitate Phase III clinical trials to validate the efficacy of the Sinopharm COVID-19 vaccine amongst the UAE population.
The purpose of a Phase III clinical trial was to continue to monitor toxicity, immunogenicity and other factors such as efficacy and safety, amongst a minimum of 15,000 volunteers.
G42 leveraged its network and robust medical due diligence and partnered with China’s largest biopharmaceutical company, Sinopharm, to provide access to the inactive vaccines for the Phase III clinical trial in UAE.
When were the Phase III trials initiated? How do you think its success panned out for the UAE?
The 4Humanity clinical trials started in July 2020 and ran for eight months. It was the world’s first Phase III pan-Arab trials for an inactivated vaccine with over 43,000 volunteers from more than 125 nationalities, supported by UAE’s healthcare authorities. This initiative achieved the highest ethnic diversity amongst other vaccine trials around the world.
The clinical trial project was operated by health practitioners from Seha who were provided facilities at five of their sites in Abu Dhabi and Al Ain. In addition, a mobile clinic was also provided, to ensure the trials were readily accessible to volunteers participating in the programme.
The success of the trials led authorities to grant Emergency Use Authorisation of the vaccine in UAE, Bahrain, Egypt and Jordan, with the subsequent rollout of the national vaccination programme.
On May 7, 2021, WHO listed the Sinopharm’s BBiBP COVID-19 inactivated vaccine for emergency use, following a thorough review, giving the green light for this vaccine to be rolled out globally.
How was vaccine efficacy computed from the controlled phase III trials?
The randomised, double-blinded clinical Phase III trials were conducted among adults, 18 years and older, to evaluate the efficacy and adverse events of the inactivated COVID-19 vaccines. Two intramuscular injections were administered to the participants, 21 days apart. In this Phase III randomised trial in adults, the Sinopharm’s BBiBP whole-virus inactivated vaccine showed efficacy of 78.1 per cent against symptomatic COVID-19 cases. The vaccine had mild and minimal side effects. It was also found to induce neutralising antibodies, like the results in Phase I and II trials.
The study concludes that treatment of adults with the inactivated SARS-CoV-2 vaccine significantly reduced the risk of symptomatic COVID-19, with mild and minimal side effects. The results of the Phase III trials have now been peer reviewed and published in the Journal of the American Medical Association, one of the world’s most prestigious medical journals.
Is there a plan to tweak the current vaccine to be able to manage new variants?
The emerging variant strains were not common in the Middle Eastern countries at the time of the Phase III trials. We are conducting more studies to investigate the neutralising capacity as well as the efficacy of the Sinopharm inactivated vaccines against emerging SARS-CoV-2 variants with increased transmission.
Is your organisation planning any further clinical trials?
Trials are on to test the efficacy of the vaccine for children aged between three and 17 years. The trials will monitor the immune response of 900 children in preparation to vaccinate children in the near future.
Can you tell us a bit about the Sinopharm booster dose?
The UAE health authorities have introduced the Sinopharm booster shot for those who have been vaccinated for over six months. Residents will be assessed to ensure that they meet the criteria through pre-appointment services. The priority, as always, remains for the elderly and those with comorbidities. Countries around the world are conducting ongoing research to study the benefits of the booster dose.
We have observed in a select group of people that the booster shot does amplify antibody response even above the levels of the prime dosage – after six to eight months of the initial two doses.
How do you see the role of G42 growing in the vaccination field especially since it has played such a crucial role in roll-out of Sinopharm?
G42 Healthcare collaborated with Sinopharm to support the UAE with immediate, effective and easy access to the vaccine. This is in line with our continuous support for UAE’s rigorous approach to managing the pandemic, including mass screening, testing and completion of Phase III clinical trials for the COVID-19 vaccine. Our organisation is steering the strategy to establish the UAE as a regional powerhouse in bio-pharma research, manufacturing and distribution, in collaboration with regulators, investors and international partners.
In line with UAE’s vision to achieve self-sufficiency in essential medicines and therapeutics, an industry consortium has been formed to lead the development of the life-sciences sector in Abu Dhabi. G42 is driving multiple initiatives in this space, to ensure that an excellent bio-pharmaceutical sector is established in Abu Dhabi within the next three years that will also serve as a regional supply hub for the entire MENA region over the next five years.
We have been leading strategy development and policy recommendations for the planned life-sciences hub in Abu Dhabi across multiple tracks, including:
Overall policy recommendations (investment, legal, intellectual property and governance)
Regulatory requirements
Pharmaceutical manufacturing
Technology and infrastructure
Skilled workforce and talent requirements
What are your other initiatives?
Among our other initiatives, we would like to talk about the Emirati Genome Programme and our efforts at analysing wastewater samples to issue early warnings to prevent the spread of infectious diseases.
The Emirati Genome Programme [EGP] is the world’s first dedicated programme.
The initiative has been approved at federal level with the formation of UAE Genomics Council on June 15, 2021. The world’s first de novo Emirati reference genome was created in December 2020 with the intention of transforming the UAE healthcare to preventive systems.
The EGP has already referenced the Emirati genome based on DNA samples from 1,000 UAE nationals using cutting edge next and third generation sequencing with artificial intelligence, and now extending the study to the wider Emirati population making EGP the most ambitious genomic program worldwide.
The EGP calls upon all UAE citizens to participate in the largest genomic study of its kind. By mapping the genetic code of as many UAE citizens as possible, this program will enhance the prediction, prevention, and treatment of disease among both present and future generations, while paving the way for further medical research benefiting the nation and humankind.
The EGP will aid the prevention of genetic and chronic diseases such as obesity, diabetes, hypertension, cancer, and asthma, as well as the development of personalized treatments according to genetic factors. Like other genomic research studies, the goal of the EGP is ultimately to realize the impact of preventative, precision-based and personalized healthcare.
All generations of Emiratis, today and in the future, will benefit from the research being undertaken by the EGP. The success of the programme depends on community as well as individual action. The EGP is advancing healthcare solutions designed by and for the Emirati community, irrespective of a person’s age, income, or gender.
Meeting the most rigorous scientific standards, the EGP is emblematic of the UAE’s rapid technological advancement and the steadfast determination of its leadership to make the country the best in the world over the course of the next 50 years.
You have also initiated a wastewater laboratory in Abu Dhabi, could you elaborate on that?
G42 Healthcare, in collaboration with the Abu Dhabi Department of Energy (DoE) has announced the launch of construction of a Wastewater Monitoring Laboratory in Abu Dhabi.
The laboratory will analyse wastewater samples and issue early warnings to prevent the spread of infectious diseases or harmful substances, as well as curb any adverse effects on the environment.
The laboratory is set to be completed in 12 months by the middle of 2022. Abu Dhabi’s Department of Health and the Environment Agency, among other entities, will be main beneficiaries as the facility.
The laboratory will be capable of testing for chemical, physical, and biological hazards, including infectious diseases (viruses/bacteria), parasites, pathogenic yeast and fungi, pharmaceutical compounds, and other lifestyle-related items – all with automated sampling and Artificial-Intelligence-powered data analysis.
The state-of-the-art wastewater analysis laboratory will be the first-of-its-kind in the MENA region, positioning Abu Dhabi and the UAE as a pioneer in this space and establishing a benchmark for future projects.
Leveraging cutting-edge technologies to analyse wastewater samples for infectious agents and harmful chemicals, application of Artificial Intelligence in this lab will enable an early warning system that will determine with high accuracy the origin of the outbreak or pollutant behaviour, detect the virus in locations with limited monitoring, and track the spread of a disease during an infectious outbreak.
The facility will focus its efforts on harmful contaminants, such as radionuclides, bio-toxins, pathogens, biological hazards, and high concentrations of industrial chemicals or illegal discharge.
