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World’s First Phase III covid-19 clinical trial inactivated Vaccine begins in the UAE

The trials are being operated by health practitioners from SEHA who are providing facilities at five of their sites in Abu Dhabi and Al Ain in addition to a mobile clinic to ensure the trials are readily accessible to volunteers participating in the program
The first WHO enlisted global clinical Phase III trial of Sinopharm CNBG’s inactivated vaccine to combat COVID-19 has started in Abu Dhabi and has been inspired by the UAE Leadership’s vision and commitment to overcome the pandemic through a global collaborative effort.
H.E. Sheikh Abdullah bin Mohammed Al Hamed, Chairman of the Department of Health, Abu Dhabi, was the first individual in the world to commence the trial of a Phase III inactivated vaccine for COVID-19. The Department’s Acting Undersecretary, Dr. Jamal Al Kaabi was the second volunteer to trial the vaccine showcasing the commitment of the UAE Government and the Health Authorities to find a cure for humanity’s biggest challenge of the 21st century.
The world’s first Phase III trial is the result of a cooperation partnership between Abu Dhabi based G42 Healthcare, currently at the forefront of the battle against COVID-19 in the UAE, and Sinopharm CNBG, the world’s sixth largest vaccine manufacturer, ranked 169th on the Fortune Global 500 list of 2018.
The trials are being operated by health practitioners from Abu Dhabi Health Services (SEHA) who are providing facilities at five of their sites in Abu Dhabi and Al Ain in addition to a mobile clinic to ensure the trials are readily accessible to volunteers participating in the program.
Over the past few months, G42 Healthcare has established a massive throughput laboratory to speed up the detection of the disease; manufactured essential PPE; conducted research into new vaccines and drug therapies and used its advanced AI capabilities to map and predict trends in the outbreak, virus mutations and help combat the disease.
The UAE was the preferred choice for the cooperation partnership to conduct the Phase III trials for the inactive vaccine as the nation is home to over 200 nationalities, allowing for robust research across multiple ethnicities and increasing its feasibility for global application on the success of the trials.
The UAE Health Authorities have recently issued a permit for up to 15,000 volunteers to take part in the trials.  G42 Healthcare and SEHA are working towards achieving a minimum of 5,000 participants in the first stage of the program to ensure the robustness of the results.
Today’s clinical trial commencement is the start of a series of national initiatives to both foster population health and to enhance the UAE’s medical research and development capabilities, including the local capacity to manufacture the vaccine.

Conducting trials

The trial formally began in the presence of the Chinese Ambassador to the UAE, H.E Ni Jian; senior health department officials and G42 Healthcare and Sinopharm CNBG representatives. The first group of volunteers including UAE nationals and expatriates received the vaccine at Sheikh Khalifa Medical City recently.
The clinical trials are being conducted under the strict guidance and supervision of the Department of Health Abu Dhabi and SEHA – the Abu Dhabi Health Services Company. The trials follow all international guidelines stipulated by the World Health Organization (WHO) and the United States Food & Drug Authority (USFDA).
The study, if successful, will be approved and accredited by the Ethics Committee for Scientific Research in Abu Dhabi.
Commenting on the start of the program, UAE Principle Investigator Sheikh Khalifa Medical City CMO and Chairperson of the National COVID-19 Clinical Management Committee Dr. Nawal Ahmed Alkaabi said, “Our participation in this trial enables us to make a major contribution in the global fight to combat the COVID-19 pandemic.  It is a matter of national pride that we are able to help facilitate the trial process that could have a worldwide impact and help people around the world to benefit from research and – if successful – the manufacture of a vaccine to fight back against this disease.”
The phase III clinical trial follows the success of the phase I and phase II trials conducted by Sinopharm in China, which resulted in 100% of the volunteers generating antibodies after two doses in 28 days.  The phase III trials are open to individual volunteers aged between 18 and 60 living in Abu Dhabi and Al Ain and will last for three to six months, with the volunteers required to be available for follow ups during this time.
A key factor for COVID-19 vaccine is the urgency around global implementation.  Computing power, data processing and diagnostic analysis are G42 Healthcare’s global competitive advantage to support the successful delivery of the world’s first phase III trials of inactivated vaccine.
G42 Healthcare CEO Ashish Koshy said, “We are enormously proud that Sinopharm CNBG has partnered G42 Healthcare in this groundbreaking phase III clinical trial in the UAE. Using our AI solutions, super-computer, and advanced diagnostics solutions for COVID-19, G42 Healthcare is uniquely postured to conduct these trials.  G42 Healthcare will be responsible for running clinical operations for this trial.  We will be leveraging our group’s technical and our own business capabilities to compute, correlate and provide fast and synthesized insights by deploying multiple AI models on the data generated during the trials to accelerate the much-awaiting results.  G42 Healthcare will be mobilizing the logistical management of the trials taking in learnings from its proven capabilities in CRO management, clinical site initiations, and other E2E program management activities.”
Mr. Jingjin Zhu, President, Biological products, Sinopharm CNBG added, “The United Arab Emirates is a nation of innovation and tolerance that is home to individuals from every part of the world and ethnic background. We will work closely with our partner to complete this clinical trial successfully, and make this vaccine available to the people in need worldwide. With the full support of local authorities, cutting-edge technologies provided by our partner G42 Healthcare, and high-quality services and supports from the medical and clinical entities, we will jointly contribute to the battle against COVID-19 worldwide.
Now that the trials have officially commenced, G42 Healthcare and the UAE Health Authorities will shortly launch a public awareness campaign to encourage UAE residents to participate in this critical to humanity clinical trial program.

Test exemption

Volunteers taking part in the Phase 3 clinical trial for a coronavirus vaccine are exempted from Covid-19 screening outside the bounds of the study, authorities have said.
The Ministry of Health and Prevention said those who have received the initial vaccine under the trial will not be required to take additional Covid-19 tests.
“The Ministry of Health and Prevention, in co-ordination with the Department of Health Abu Dhabi, has exempted volunteers of the Phase III Covid-19 vaccine trials from performing any other Covid-19 tests outside the trial’s framework,” the department said.
“The Ministry also decided to use the Al Hosn app to identify volunteers so they can benefit from the exemption, and they are required to install the application on their smartphones.”
The World Health Organization has recognized four clinical trials for Covid-19 vaccines that have reached Phase 3 – one American, one British and two Chinese.
If the UAE trial is successful, the vaccine will be approved for use among the public and manufacturing will begin to produce it at scale.

Expansion of vaccine trials

The UAE announced recently that its phase 3 clinical trials for coronavirus vaccine are now open to volunteers outside of Abu Dhabi for the first time.
In a statement carried by state news agency WAM, the UAE’s Ministry of Health and Prevention said it is now dedicating the Al Qarayen Health Center in Sharjah as the first center outside the Emirate of Abu Dhabi to register, screen and test volunteers wishing to participate in the world’s first Phase III clinical trials of an inactivated vaccine to combat COVID-19.
The move has been taken in cooperation with the Abu Dhabi Department of Health, Abu Dhabi Health Services Company, SEHA and G42 Healthcare.
Al Qarayen Health Center has the capacity to register and screen over 500 volunteers a day and is open to residents from Sharjah and neighboring emirates as the trials continue to gather nationwide momentum since the launch of #4Humanity campaign in July.
It is being managed by G42 Healthcare in partnership with the ministry and will play a central role in facilitating procedures for registering volunteers and conducting necessary tests.
Commenting on the development, Health Minister Abdul Rahman Bin Al Owais said, “The UAE health sector adopts a flexible and multi-track strategy in dealing with the COVID-19 pandemic, which depends on competent authorities conducting the largest possible number of medical tests and providing necessary care for the infected persons.”
”Meanwhile, we are strengthening our cooperation with international partners to support the development of a safe vaccine against the disease. Thus, expanding the geographical scope of the #4Humanity campaign to include all emirates aims to enhance the results of clinical trials and ensure the safety and effectiveness of the vaccine on a larger segment of individuals”.
Al Owais added, “We are optimistic about achieving promising results that would support the global efforts being made to develop the vaccine. Allocating Al Qarayen Health Center as the first center outside of Abu Dhabi to register, screen and test volunteers is yet another a distinct contribution from the UAE, to be added to its impeccable record of achievements in the field of clinical research thanks to the country’s advanced infrastructure, the efficiency of its health system and ability to conduct medical research according to the highest international standards”.
CEO of G42 Healthcare, Ashish Koshy, said, “The #4Humanity program has captured the imagination of residents in every emirate who are keen to volunteer and help find a cure for the world’s biggest health challenge of the 21st Century.
“Since the launch, it became quickly apparent of the strong desire of health authorities and residents across the UAE to play their part and help ensure the success of these trials at a truly national level. Our teams are now working closely with MOHAP and SEHA to ensure our advanced technology and measurement process complements their frontline testing of volunteers.”