The world’s first phase 3 clinical trial of a COVID-19 vaccine has formally begun.
The COVID-19 vaccine by pharmaceutical company Sinopharm, whose headquarters is in Shanghai, China, started in the United Arab Emirates in partnership with Dubai-based G42 Healthcare and Abu Dhabi Health Services.
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The first group of up to 15,000 registered volunteers – including UAE nationals and expatriates – received the vaccine at Sheikh Khalifa Medical City in Abu Dhabi on Thursday.
Sheikh Abdulla bin Mohammed Al Hamed, Chairman of the Department of Health of the UAE, was one of the first to participate in the vaccination trial, according to a statement released by G42.
More than 1,000 Sinopharm employees, including the head of the company, have been voluntarily vaccinated, as its phase-I and phase-II clinical trials showed promising results with few adverse reactions compared to other vaccines currently undergoing trials.
The inactivated vaccine researched by Sinopharm has proven to be effective to all strains of the novel coronavirus detected so far, Yang Xiaoming, the head of Sinopharm, told Reuters.
The trials are being operated by health practitioners from Abu Dhabi Health Services, which also 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 the volunteers participating in the program, according to a statement by G42.
Inactivated vaccines are well known and have been used against diseases such as influenza and measles.
No COVID-19 vaccine has yet been approved for commercial use. According to a WHO summary of the state of vaccine development for COVID-19, there are 23 potential vaccines in human trials, with three of them in or starting large-scale late stage, or Phase III, trials to test efficacy.
The trial will test two vaccine strains and a placebo. Two doses three weeks apart will be administered and volunteers followed for a year, said Nawal Alkaabi, head of the UAE’s COVID-19 Clinical Management Committee.
Around 15,000 volunteers over three to six months will be recruited, initially in Abu Dhabi. They will be 18 to 60 years of age with no serious underlying medical issues and without previous COVID-19 infection, Alkaabi said.
G42 Healthcare and SEHA are working toward a minimum of 5,000 participants in the first stage of the program to ensure the reliability of the results.
Worldwide a total of 14.6 million people have confirmed cases of COVID-19, with almost 609,000 deaths. More than 60% of all confirmed cases were in the US, India and Brazil.
There are three COVID-19 vaccine candidates in the last-stage of clinical trials. The vaccine developed by Moderna began its Phase 3 trial later this month, followed by those developed by AstraZeneca and Oxford University in the UK and Johnson & Johnson.