On Wednesday, the UAE officially registered a COVID-19 vaccine, nearly six months after it first kicked off late-stage vaccine trials, dubbed '4 Humanity', in the country.
The announcement is a significant vote of confidence by the UAE authorities in the safety and efficacy of the vaccine that has been developed by Chinese experts.
While further details are still awaited on what the registration means for residents in the country, here is the lowdown on the vaccine that was tested as part of the 4 Humanity trials.
Which COVID-19 vaccine has been officially registered in the UAE?
In July, UAE kicked off a Phase III trials for a vaccine developed by Chinese experts. It was referred to as the Sinopharm inactivated vaccine.
Sinopharm refers to the state-owned pharmaceutical group in China, the China National Pharmaceutical Group or Sinopharm Group. Its vaccine and bioscience subsidiary is the China National Biotec Group Co Ltd (CNBG).
CNBG was in the process of developing and trialling vaccines against COVID-19 with two of its institutes: the Beijing Institute of Biological Products, and the Wuhan Institute of Biological Products.
On December 9, the UAE officially registered the inactivated vaccine developed by the Sinopharm CNBG’s Beijing Institute of Biological Products.
What is the make-up of the UAE-registered COVID-19 vaccine?
The vaccine tested in the 4 Humanity trials was an inactivated vaccine, i.e., it consists of virus particles, bacteria, or other pathogens that have been grown in culture and have lost their disease-producing capacity.
“The inactivated virus in the vaccine cannot cause the disease. It is a dead virus, and many other vaccines around the world use an inactivated virus. There was also no significant side effect note in the first two phases of the trial. In fact, there was no difference in the people who received the placebo or the inactivated vaccine [in terms of side effects],” Dr Nawal Al Kaabi, UAE principal investigator and chief medical officer at Abu Dhabi’s premier public health facility, the Shaikh Khalifa Medical City, said at a press briefing following the start of the trials.
How did the China-developed vaccine fare in previous stages of testing?
Sinopharm CNBG announced in July that the COVID-19 vaccine to be tested in the 4 Humanity trial had seen a positive response in the earlier stages of testing. All volunteers in China who had participated in Phase I and Phase II trials had successfully generated antibodies against COVID-19 when two doses of the vaccine were delivered 28 days apart. In addition, no adverse reactions had been recorded.
When did the trials kick off?
Following an online video ceremony held between Abu Dhabi and Beijing, UAE health authorities announced the commencement of the world’s first phase III clinical trials of a COVID-19 inactivated vaccine on June 23. In attendance were UAE Health Minister, Abdulrahman Al Owais, and Abdullah Al Hamed, chairman of Abu Dhabi’s health regulator, the Department of Health (DoH).
On July 16, two senior health officials in Abu Dhabi — Al Hamed, and DoH undersecretary Dr Jamal Al Kaabi — became the first people to receive the vaccine shots for the 4 Humanity trials in the UAE.
Who conducted the 4 Humanity trials in the UAE?
The trials were led by G42 Healthcare, the health care wing of an artificial intelligence and cloud computing firm based in Abu Dhabi, Group 42. They were overseen by Abu Dhabi’s health regulator, the Department of Health — Abu Dhabi (DoH), and the UAE Ministry of Health and Prevention, while medical protocols were to be handled by the Abu Dhabi Health Services Company (Seha), the emirate’s public health provider.
How many people participated in the 4 Humanity trials?
Officials had initially announced that they were looking to recruit 15,000 volunteers. Within six weeks, more than 31,000 volunteers had been registered, and health authorities closed down registrations on August 30. The majority of the volunteers were residents of Abu Dhabi Emirate, because registration had initially been opened to those living in the emirate.
What was the vaccine trial procedure for volunteers?
Volunteers could sign up on the dedicated 4 Humanity website, or walk into the Abu Dhabi National Exhibition Centre registration facility, and later the Al Qarayen Health Centre in Sharjah. They were first tested for COVID-19, or had to present a negative COVID-19 PCR test.
After being screened for health risks and general well-being, eligible volunteers received the first vaccine dose. They were then asked to return on a designated day about three weeks later for the second dose.
In the interim, they had to maintain a diary of their general health status, while health professionals carried out regular teleconsultations with them.
Following the second vaccine shot, volunteers were asked to come in for blood tests two weeks later.
What did the clinical study of the vaccine involve?
The Phase III trials in the UAE delivered a placebo, or one of two vaccine strains, to volunteers. The clinical study was double-blind, which means that neither the volunteer, nor the vaccine developers and health care professionals, knew exactly what treatment an individual is receiving until the study is concluded.
Analysis of the results was then conducted under the supervision of MoHAP and the DoH, and this process also made use of a supercomputer owned by G42 Healthcare. Patient data was however only held by Seha.
G42 is also running Phase III trials for the vaccine in Egypt, Jordan and Bahrain.
When did the 4 Humanity vaccine receive emergency use approval?
Following initially encouraging results, including no adverse effects noted in 1,000 individuals with chronic diseases, the vaccine was given emergency use approval on September 15. Since then, hundreds of people on the front lines, including health care workers, airport staff, educators, leaders and ministers, in the UAE have been vaccinated.
His Highness Sheikh Mohammed bin Rashid Al Maktoum, Vice-President and Prime Minister of the UAE and Ruler of Dubai, received his first dose of the vaccine on November 3.
When it was registered in the UAE on December 9, what was announced about the 4 Humanity trial vaccine’s safety?
The announcement said that MoHAP and the DoH have reviewed Sinopharm CNBG’s interim analysis of the Phase III trials, which show that the Beijing Institute of Biological Product’s inactivated vaccine has 86 per cent efficacy against COVID-19 infection. The analysis also shows the vaccine to have 99 per cent seroconversion rate of neutralising antibody, and 100 per cent effectiveness in preventing moderate and severe cases of the disease. Furthermore, the analysis shows no serious safety concerns.
The UAE, which authorised the use of the vaccine on an emergency basis in September, is now conducting Post-Authorisation Safety Study (PASS), and Post-Authorisation Efficacy Study (PAES). These ongoing studies show similar safety and efficacy profiles as the interim analysis.
Is the officially registered vaccine available to the public? How can I register?
The registered vaccine has not yet been offered to the public officially, so details on how to register to receive it are still awaited from health authorities.
Watch: Race to develop COVID-19 vaccine
What Phase III trial volunteers say
A total of 31,000 people volunteered for the Phase III trials of the COVID-19 vaccine developed by Chinese pharmaceutical giant, Sinopharm China National Biotec Group (CNBG). As registration was initially limited to Abu Dhabi Emirate, the vast majority of the volunteers live in the emirate.
Hussa Al Mansoori, 49, Emirati IT professional
“I am excited to have been part of this historic trial. It is a moment to celebrate. I have to also say that I was always confident that the UAE would be one among the first countries to beat COVID-19. It was this trust in the leadership that led me to sign up for the trials on August 2, and I have been healthy throughout. I only hope the vaccine will soon provide immunity to the wider UAE community, and allow us to leave this ‘COVID-19 era’ behind. I feel like I can already see an end to it now, especially after today’s announcement.”
Mohammed Anisur Rahman, 50, Bangladeshi archive clerk
“As soon as I heard of the trials, I was eager to sign up for them, and I became the first Bangladeshi expat in the UAE to become a vaccine trial volunteer on July 27. Even though I have been volunteering for tasks on the front lines from the start of the outbreak, I have been free from COVID-19, and I have no doubt this points to the efficacy of the vaccine. Today’s official registration of the vaccine is great news, and I am proud to have been a volunteer who helped increase the demographic diversity of the volunteer base.”
Dr Sayyed Munir Pasha, 45, Indian radiology specialist at LLH Hospital
“I am delighted the trials have helped prove the efficacy of the vaccine that I received first on August 1. Despite working on the front lines, I have remained free from COVID-19. In recent weeks, after the vaccine received emergency approval in the UAE, I have seen many of my colleagues also get vaccinated. For the moment, I am waiting till the vaccine becomes publicly available so that I can vaccinate my two children and wife as well.”
Dr Mohammed Elnaggar, 46, Egyptian urology specialist at Burjeel Royal Hospital, Al Ain
“My aim when I signed up for the trials was to contribute to making the world healthy again. With the results released today, it shows this vaccine has the potential to protect us from COVID-19, and I am proud to have participated in trials to test its efficacy.”
November 3: His Highness Sheikh Mohammed bin Rashid Al Maktoum, Vice-President and Prime Minister of the UAE and Ruler of Dubai, receives his first dose of the vaccine.
September 17: G42 expands the Sinopharm BG Phase III trials to Egypt.
September 15: The UAE grants emergency approval for the use of the Sinopharm CNBG vaccine on frontliners, following encouraging initial results. No major side effects have been recorded, and 1,000 people with chronic conditions who volunteered for the trials have faced no adverse effects. The vaccine is then delivered to frontline workers in health care, education, armed forces and police, as well as among ministers and leaders.
August 30: Following the registration of 31,000 volunteers from 125 nationalities, registration for the Phase III trials is closed. The volunteer registration centres continue operating to service trial participants.
August 27: G42 expands the Sinopharm BG Phase III trials to Jordan.
August 12: G42 expands the Sinopharm BG Phase III trials to Bahrain.
August 5: Al Qarayen Health Centre in Sharjah becomes the first facility outside Abu Dhabi to register volunteers for the Phase III trials of the Sinopharm CNBG vaccine.
July 29: The first volunteer registration centre is opened at the Abu Dhabi National Exhibition Centre, with the capacity to process 800 people a day.
July 16: The trials officially kick off in Abu Dhabi. Two of the emirate’s senior health officials — DoH chairman Abdullah Al Hamed, and undersecretary Dr Jamal Al Kaabi — are the first people to volunteer for the vaccine shots.
A website is launched for residents to register for the trials, dubbed 4 Humanity. Officials announce criteria that will be considered when selecting trial participants: volunteers have to be aged between 18 and 60 years, should not have been infected by COVID-19 previously, non-immunocompromised, and free of chronic diseases.
June 23: Following an online video ceremony held between Abu Dhabi and Beijing, UAE health authorities announce the commencement of the world’s first phase III clinical trials of a COVID-19 inactivated vaccine. At this point, Sinopharm CNBG had already announced that Phase I and II trials in China had seen all volunteers generate antibodies against COVID-19 when two doses of the vaccine were delivered 28 days apart, and that no adverse reactions had been reported.
The trials would be led by G42 Healthcare, the health care wing of an artificial intelligence and cloud computing firm based in Abu Dhabi, Group 42. They were to be overseen by Abu Dhabi’s health regulator, the Department of Health — Abu Dhabi (DoH), and the UAE Ministry of Health and Prevention, while medical protocols were to be handled by the Abu Dhabi Health Services Company (Seha), the emirate’s public health provider.
Health authorities initially say they are looking to register 15,000 people.
Vaccine race: Other candidates
By Alex Abraham, Senior Associate Editor
More than 140 drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19.
There are 87 preclinical vaccines in active development and 54 others in the three phases of trials. Six vaccines have already been approved for limited use in some countries.
◆ Pfizer-BioNTech
Pfizer and German biotechnology company BioNTech have developed a vaccine that uses messenger RNA to prompt the immune system to recognise the coronavirus. A final analysis of their phase 3 data suggested that their vaccine is 95% effective at preventing COVID-19, the companies announced on Nov. 18. The companies became the first to submit a request for emergency use authorisation on Nov. 20. The UK became the first Western country to start a mass vaccination programme on December 8.
◆ Moderna
This candidate vaccine (mRNA-1273), developed by US biotech company Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), was the first to be tested on humans in the US. An analysis of the early data suggested that Moderna's vaccine is 94.5% effective in protecting against COVID-19, the company announced on Nov. 16.
◆ Oxford-AstraZeneca
The vaccine ChAdOx1 nCoV-19, popularly known as the Oxford vaccine, was developed by researchers at the University of Oxford and AstraZeneca. The vaccine candidate is 70% effective in preventing COVID-19 and can be 90% effective when given in the right dose, the University of Oxford announced on Nov. 23. The vaccine is given in two doses, 28 days apart and is still being tested in phase 3 clinical trials across the globe, including in the US, UK and Brazil.
◆ Sputnik V
The Russia Ministry of Health's Gamaleya Research Institute has developed a coronavirus vaccine candidate, now known as "Sputnik V," based on two different adenoviruses, or common cold viruses that infect humans. These viruses are genetically altered to not replicate in humans and to code for the coronavirus's spike protein.
Russia announced on Nov. 24 that its vaccine was more than 91.4% effective in preventing COVID-19, according to results from a second analysis of its phase 3 trial.
◆ Johnson & Johnson
Johnson & Johnson’s vaccine is a one-dose shot using technology based on the development and production of adenovirus vectors, or gene carriers. Similar technologies were used to develop and manufacture the company’s Ebola vaccine.
Scientists test a new vaccine on cells and then give it to animals such as mice or monkeys to see if it produces an immune response.
PHASE 1 SAFETY TRIALS:
Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
PHASE 2 EXPANDED TRIALS:
Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.
PHASE 3 EFFICACY TRIALS:
Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus. The trials are large enough to reveal evidence of relatively rare side effects that might be missed in earlier studies.
APPROVAL:
Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorisation before getting formal approval. Once a vaccine is licensed, researchers continue to monitor people who receive it to make sure it’s safe and effective.
PAUSED:
If investigators observe worrying symptoms in volunteers, they can put a trial on pause. After an investigation, the trial may resume or be abandoned.
Types of vaccines
There are four categories of vaccines in clinical trials: Whole Virus, Protein Subunit, Viral Vector, and Nucleic Acid (RNA and DNA). Some of them try to smuggle the antigen into the body, others use the body’s own cells to make the viral antigen.
◆ Whole Vaccines
Whole virus vaccines use a weakened (attenuated) or deactivated form of the pathogen that causes a disease to trigger protective immunity to it. There are two types of whole virus vaccines. Live attenuated vaccines use a weakened form of the virus, which can still grow and replicate, but does not cause illness. Inactivated vaccines contain viruses whose genetic material has been destroyed by heat, chemicals or radiation so they cannot infect cells and replicate, but can still trigger an immune response.
Both are tried and tested vaccination strategies, which form the basis of many existing vaccines – including those for yellow fever and measles (live attenuated vaccines), or seasonal influenza and hepatitis A (inactivated vaccines). Bacterial attenuated vaccines also exist, such as the BCG vaccine for tuberculosis.
◆ Nucleic Acid
Nucleic acid vaccines use genetic material from a disease-causing virus or bacterium (a pathogen) to stimulate an immune response against it. Depending on the vaccine, the genetic material could be DNA or RNA; in both cases it provides the instructions for making a specific protein from the pathogen, which the immune system will recognise as foreign (an antigen). Once inserted into host cells, this genetic material is read by the cell’s own protein-making machinery and used to manufacture antigens, which then trigger an immune response.
Several DNA vaccines are licenced for animal use, including a horse vaccine against West Nile virus.
◆ Viral Vector
Viral vector-based vaccines differ from most conventional vaccines in that they don’t actually contain antigens, but rather use the body’s own cells to produce them. They do this by using a modified virus (the vector) to deliver genetic code for antigen, in the case of COVID-19 spike proteins found on the surface of the virus, into human cells. By infecting cells and instructing them to make large amounts of antigen, which then trigger an immune response, the vaccine mimics what happens during natural infection with certain pathogens - especially viruses. This has the advantage of triggering a strong cellular immune response by T cells as well the production of antibodies by B cells. An example of a viral vector vaccine is the rVSV-ZEBOV vaccine against Ebola.
◆ Subunit Vaccines
Rather than injecting a whole pathogen to trigger an immune response, subunit vaccines (sometimes called acellular vaccines) contain purified pieces of it, which have been specially selected for their ability to stimulate immune cells. Because these fragments are incapable of causing disease, subunit vaccines are considered very safe.
Concern over vaccine for all
Governments around the world are making agreements with multiple developers to ensure they lock in delivery of the products that are ultimately approved for widespread use.
The UK has agreed to buy more than 350 million doses of vaccine from seven different producers.
The European Union reached an agreement with Pfizer in November to buy up to 300 million doses and Canada has an agreement to purchase up to 76 million.
So will poor nations miss out in the early rush for vaccines?
Campaigners have raised the alarm that nine out of 10 people in dozens of poor nations could miss out on getting vaccinated against COVID-19 next year because rich countries have hoarded far more doses than they need, Reuters reported.
Rich nations, home to 14 per cent of the global population, had bought 53 per cent, of the total stock of the most-promising vaccines as of last month, said the People's Vaccine Alliance, a coalition including Oxfam, Amnesty International and Global Justice Now.
They said pharmaceutical companies working on COVID-19 vaccines should openly share their technology and intellectual property through the World Health Organisation (WHO) so more doses can be manufactured.
Most people in 67 low- and lower middle-income countries including Bhutan, Ethiopia and Haiti, risk being left behind, they said.
Among the three COVID-19 vaccines for which efficacy results have been announced, almost all the available doses of two of them - Moderna and Pfizer/BioNTech - have been acquired by rich countries, the Alliance report said.
The EU, United States, Britain, Canada, Japan, Switzerland, Australia, Hong Kong, Macau, New Zealand, Israel and Kuwait have acquired 53% of these potential doses - with Canada buying enough to vaccinate its population five times over, Oxfam said.
- With inputs from Reuters, NYT, AP
