Phase III COVID-19 vaccine trials in the UAE: All you need to know about them

Abu Dhabi: On Thursday, Abu Dhabi announced the launch of the world’s first Phase III trials of an inactivated vaccine against the coronavirus. The trials will continue over the next few months, and are expected to enroll thousands of volunteers from across the country.

This is a new step in the UAE’s fight against COVID-19. Having already registered the second highest COVID-19 testing rate in the world, and after reporting no deaths in 24 hours on Wednesday, there is cause for excitement, even as the number of COVID-19 cases around the world continues to rise.

Here’s everything you need to know about the trials:

Who developed this vaccine?

The vaccine has been developed by Chinese pharmaceutical giant, Sinopharm China National Biotec Group (Sinopharm). The Chinese state-run firm is the world’s sixth largest vaccine manufacturer, and its vaccine is an inactivated vaccine.

What is an inactivated vaccine?

An inactivated vaccine uses a killed virus to trigger an ‘immune response’ in the human body.

So in essence, administration of this vaccine means the killed novel coronavirus – Sars-CoV-2 – will be given to recipients. This, in turn, will induce the human body to produce antibodies to kill the virus in a process known as immune response.

Later, if a vaccinated individual comes into contact with a live virus, the body will know how to launch the same immune response to keep the individual safe.

This in contrast to vaccines that use:

-Live, weakened viruses (live-attenuated vaccines against measles, chickpenpox and yellow fever)

-Parts of the antigen (subunit, recombinant, polysaccharide or conjugant vaccines against Hepatitis B, HPV, pneumococcal disease and meningitis)

-Toxins produced by the antigen to cause the disease (toxoid vaccines against diphtheria and tetanus).

Is it dangerous to inject the same virus that causes the disease?

There are no known risks of using a killed virus or inactivated vaccine. The virus is grown in lab cultures under strict, top-level biosecurity standards, and then killed with heat, radiation or formaldehyde. This killing eliminates the virus’ ability to trigger the disease, in this case, COVID-19.

All of this is done under strict safety conditions so that even the bio-engineers and lab technicians do not contract the virus.

“An inactivated vaccine [such as this] cannot cause the disease. Sinopharm, and indeed many other vaccine manufacturers have been producing vaccines in this manner for years,” assured Dr Nawal Al Kaabi, UAE principal investigator, chief medical officer at Abu Dhabi’s Sheikh Khalifa Medical City (SKMC) and chairperson of the National COVID-19 Clinical Management Committee.

What other vaccines use killed viruses in them?

Currently, inactivated vaccines are used to protect against Hepatitis A, the flu via the flu shot, rabies and polio via the polio shot.

What are the stages of vaccine development?

Under international protocols, vaccine development goes through four different clinical stages. These happen after animal testing, and studies into the drug’s ability to elicit an immune response. The first three stages are pre-marketing, and the final stage is conducted post-marketing.

In Phase I, safety and immunogenicity studies are performed on a small number of closely monitored subjects. Researchers look at safe dosage levels and side effects.

In Phase II, hundreds of human subjects receive the vaccine to determine its efficacy and safety in a wider group of people.

In Phase III, thousands of individuals are enrolled. The vaccine’s efficacy is studied, it is compared to other interventions in use, and adverse effects, if any, are noted so that the vaccine can be safely licensed.

In Phase IV, the administration and impact of the vaccine is studied in the general population, and reports of side effects after widespread use are collected.

How safe and effective is the Sinopharm vaccine?

Sinopharm’s vaccine has undergone Phase I and Phase II trials in China, and the company reported that the vaccine triggered a strong neutralising antibody response.

A total of 1,120 volunteers participated in PhaseI/II. They received two doses of the vaccine either 14, 21 or 28 days apart at low, medium or high dosing strengths, or a placebo. The company reported in June that all patients who received the medium-strength vaccine 28 days apart produced detectable levels of antibodies against the vaccine, known as seroconversion rate. Also, 97.6 per cent of those who received low or high doses 28 days apart produced detectable levels of antibodies.

No adverse effects were reported.

When did the Phase III trials begin in the UAE?

The trials were effectively kicked off on Wednesday, July 15 when Sheikh Abdullah bin Mohammed Al Hamed, chairman at Abu Dhabi’s healthcare regulator, the Department of Health (DoH), and Dr Jamal Al Kaabi, DoH acting undersecretary, were assessed and administered the vaccine at SKMC.

By taking the vaccines themselves, the senior officials demonstrated their confidence in the safety of the trials, and also the UAE’s keenness to advance the fight against COVID-19.

Dr Jamal Al Kaabi also told Gulf News he was “feeling fine” after 24 hours, and that he had “a great feeling” about the trials.

Public recruitment for the trials is expected to start next week.

Who is running the trials?

Sinopharm has partnered with G42 Healthcare, a privately-held artificial intelligence and cloud computing firm based in Abu Dhabi.

Ashish Koshy, chief executive officer at G42 Healthcare, said the company is sponsoring the trials, with the medical portion, including medical assessment, vaccine administrations and follow-ups, to be run by Abu Dhabi public health provider, Abu Dhabi Health Services Company.

He said the company has set up a massive throughput laboratory to speed up the detection of the disease, which can process 15,000 to 20,000 samples a day.

“We also have the 32nd fastest supercomputer, which can build models to accelerate the clinical trial,” Koshy said.

In addition, G42 has manufactured essential PPE, conducted research into new vaccines and drug therapies, and used AI capabilities to map and predict trends in the outbreak and virus mutations.

How many people will be recruited for the Phase III trials?

UAE health authorities have issued a permit for 15,000 participants in the Phase III trials, with 5,000 in the first stages to be conducted in Abu Dhabi and Al Ain.

Who can participate in the trial?

People of all nationalities aged between 18 and 60 years, and living in the UAE, are eligible to participate in the trials, as long as they meet other inclusion criteria.

Dr Al Kaabi explained that there are strict inclusion and exclusion criteria, in accordance with international standards.

“So anyone who is suffering from a severe disease like cancer, is immunocompromised, has received a recent live vaccine or blood products, or suffered from COVID-19, will be excluded,” Dr Al Kaabi told Gulf News.

In the first stages, people will be recruited from Abu Dhabi and Al Ain alone.

Again, who cannot participate?

Quite a few groups of people cannot participate in the trials, in accordance with standards set by the WHO and the United States Food and Drug Administration.

Some of the groups are:

-People who have contracted COVID-19 in the past or are suffering from it

-People suffering from severe diseases like cancer

-People who are immunocompromised

-People who have recently received a live vaccine or blood products

-People who are younger than 18 years, or older than 60 years

How can I participate in the trial?

Officials said a dedicated website will soon be launched to allow people to register. They can do so on 4humanity.ae. The dedicated website requires potential volunteers to submit their personal details and contact information. A special hotline has also been set up at 02 8191111 to respond to volunteer queries about the trials.

What happens after I register for the trials?

Participants will be asked to come down to one of five Seha facilities in Abu Dhabi and Al Ain, and will undergo a physical exam. Tests will be conducted to ensure that they are fit for the trials.

If approved, the volunteer will be administered a vaccine shot, akin to the flu shot. They will then be given a vaccine diary to record all signs and symptoms, and a healthcare team will follow up via in-person consultations and teleconsultations.

Three weeks later, a second shot of the vaccine will be administered.

Why are two vaccine shots required?

Dr Al Kaabi said that in the case of inactivated vaccines, more than one dose is required to trigger an immune response.

How long does the trial last?

For each individual, the trial will last 42 days.

The overall trial period in the UAE is expected to be between three to six months.

Who will ensure my safety during the trials?

Healthcare teams from Seha will follow up with trial volunteers during the trial itself, and on a monthly basis for a year after it concludes.

The trials also follow all international guidelines stipulated by the World Health Organization (WHO) and the United States Food & Drug Authority (USFDA).

Why has the UAE been chosen for these Phase III trials?

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 study, if successful, will be approved and accredited by the Ethics Committee for Scientific Research in the wmirate of Abu Dhabi.

Authorities said the Sinopharm-G42 partnership will also allow UAE residents to gain quick access to a vaccine, if it proves safe and effective.

Who will produce the vaccine, if all goes well?

Dr Walid Abbas Zaher, group research director at G42 Healthcare, said the agreement with Sinopharm also allows for the vaccine, if it passes the third phase successfully, to be produced in Abu Dhabi.

“The agreement allows for production in Abu Dhabi, and a production plan will be announced after the end of the trial,” he said.

How can I be sure that my patient data will be safe?

All patient data will only be held by Seha healthcare facilities, and any information shared with external parties will be de-identified, as per international standards.

Koshy said entire process will be monitored by two clinical research organisations – one local and other international.

When can this vaccine be ready for mass marketing?

G42 and Sinopharm are hoping to accelerate the development of a safe and effective vaccine that could enter the market by the end of 2020 or early 2021.

What do the officials say?

“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,” said Dr Nawal Al Kaabi, UAE principal investigator, chief medical officer at Abu Dhabi’s Sheikh Khalifa Medical City (SKMC) and chairperson of the National COVID-19 Clinical Management Committee.

“I am really excited about this trial as a physician. I have always believed in the importance of developing a research ecosystem, and personally supported research initiatives. Fortunately, we received support from our leadership for these trials. It is the beginning of a historic moment, and God willing, we will have a great conclusion to these trial. I have a good feeling,” said Dr Jamal Al Kaabi, acting undersecretary at the Abu Dhabi Department of Health and the second person to participate in the Phase III trials.

“This partnership highlights the UAE’s broad multifaceted approach to combating the virus, which includes innovative research into effective treatments, enhanced testing capabilities, and continuous cooperation with the international community. The UAE will spare no effort in contributing to solutions to the current pandemic, solutions that will aid humanity’s ability to overcome the current pandemic,” said Sheikh Abdullah bin Mohammed Al Hamed, chairman at the Abu Dhabi Department of Health and first person to participate in the Phase III trials.

“Now more than ever, nations need to work in close partnership between the government and private sectors to create new initiatives, launch programs, develop policies, drive rigorous research, and develop capacity. It is for this reason that the United Arab Emirates welcomes all contributions by countries of the world, innovative entities and creative individuals who are committed to creating opportunities for joint collaboration towards confronting the threat of COVID-19 and defeating this global pandemic,” said Abdul Rahman Mohammed Al Owais, UAE Minister of Health and Prevention.

“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 trials 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,” said Mr. Jingjin Zhu, president of biological products at Sinopharm Chinese National Biotec Group.

“We are enormously proud that Sinopharm has partnered with G42 Healthcare in this groundbreaking phase III clinical trial in the UAE. Using our AI solutions, super-computer, 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 synthesised insights by deploying multiple AI models on the data generated during the trials to accelerate the much awaiting results. G42 Healthcare will be mobilising the logistical management of the trials taking in learnings from its proven capabilities in CRO management, clinical sites initiations and other E2E programme management activities,” said Ashish Koshy, chief executive officer at G42 Healthcare.