As nations around the world search for a panacea for Covid-19, here in the UAE one of the world’s seven Phase III trials – the last and crucial stage in the development of a vaccine before implementation – is under way. This puts the UAE right at the forefront of the fight against the pandemic, alongside China, the US, India and Europe. UAE residents of 115 nationalities have joined the 4Humanity campaign, organised by G42 Healthcare in partnership with government entities, to carry out the clinical trials of the inactivated vaccine developed by China’s Sinopharm CNBG. So exactly how has the UAE become involved in such a global effort?
“The UAE has a track record of successfully managing clinical trial programmes in the country and that has helped to influence the decision to play host to the world’s first Phase III clinical trials of an inactivated vaccine,” explains Dr Nawal Ahmed Alkaabi, UAE Principal Investigator, Shaikh Khalifa Medical City CMO and Chairperson of the National Covid-19 Clinical Management Committee.
The key to the trial vaccine is the fact that it is inactive which, explains Dr Walid Zaher, Chief Research Officer and Vaccine Study Director at G42 Healthcare, has been successfully used for many tried-and-tested vaccinations including influenza, hepatitis and diphtheria vaccines.
“It is called an inactive vaccine because it contains an inactivated microorganism (or part of one) that can help the immune system prepare itself for an eventual infection,” says Dr Zaher. “It is recognised by the immune system, without being infectious, to prevent individuals from getting the disease the vaccine is trying to protect you from.
“Phase III of a clinical trial is required to determine the efficacy and safety of the vaccine in a healthy population and is typically the final major stage before a decision is made to proceed and manufacture the vaccine.”
It follows the success of Phase I and Phase II conducted by Sinopharm in China, which resulted in 100 per cent of the volunteers generating antibodies to SARS-CoV-2, the virus that causes Covid-19, after two doses in 28 days.
On the heels of the successful vaccination trial programme in the UAE where the second shot is being administered to many of the volunteers, the Phase III trials are now expanding and have headed to nearby Bahrain and Jordan as their first and second regional locations respectively.
The close partnerships between the health authorities in the UAE and Bahrain as well as Jordan made these logical destinations to extend the trials.
“Typically, trials of this nature around the world require a large number of participants, so we have made the decision to expand the scope of the trials to the region,” says Ashish Koshy, CEO of G42 Healthcare. “The close partnerships between the health authorities in the UAE and Bahrain as well as Jordan made these logical destinations to extend the trials. The Bahrain and Jordan trials – which are a part of the same trials here in the UAE and using the same procedures and vaccine – are already attracting significant volunteer numbers and the demographics and ethnic breakdown of these countries are also very diverse, as they are here in the UAE.”
With the trial having many different aspects, it is now time to look at the effects of the vaccine in its final phase.
“In terms of the broader scope of the trials, we are now completing the vital first phase, which has been the recruitment of volunteers, and we will now be entering the next phase to review and assess the impact of the vaccine on the volunteers,” says Dr Alkaabi.
Each volunteer’s journey starts with their enrolment, screening and testing to check they are suitable candidates for the trial. Once accepted, they are immediately given their first vaccine and the next shot is given after 21 days. Over their 49- day journey they have regular check-ups, either physically or over the telephone, to ensure they are well. On completion of this stage of the journey, volunteers are regularly monitored once or twice every month, which will eventually turn into check-ups once every three months.
Volunteers have been keen to get involved and become a part of the UAE’s history. “I am very optimistic that the clinical trials will be successful for the UAE and for humanity, and we will have a successful vaccine for Covid-19,” explained one of the thousands of Emirati volunteers who have signed up for the programme.
So far, this collaborative effort is on track. “It will take us many months yet to know the final impact and results of the trials, but the benefit of G42 Healthcare’s computing power means we can accelerate processing the results far quicker than ever before,” explains Koshy. “Given the success of Phase I and II, we are optimistic about a positive outcome for the results and the clinical conclusions.”
It seems there might finally be some light at the end of the tunnel in the battle against Covid-19 and both nationals and expatriates are already excited at the prospect.
“I hope that the vaccine trial is successful and that it can be rolled out,” says a British expat. “I think it’s great that the UAE are running vaccine trials. I was not surprised to hear about it as we seem to have been at the forefront of fighting Covid-19.”
Meanwhile an Indian resident says she is keen to have the vaccine once it is approved: “I personally am very eager to receive the vaccine as it will allow us to travel safely and I’ll feel confident knowing my children are at school in a 100 per cent safe environment.”
Certainly, this trial could be one of the best things to happen in 2020. “It is exciting that we are at this stage,” says a UAE-based British resident. “The UAE always strives to be the best but something on this scale should put us on everybody’s radar!”