“With around 20 million positive cases and 749,000 deaths, the COVID-19 juggernaut is in an unstoppable momentum in the world. Lockdowns and other measures have not been effective. The only hope is a vaccine. So, when a government calls in volunteers for the world’s first Phase III human trial of COVID-19 vaccine, why should I step back? I volunteered for the world. And I was not alone, there were many like me.”
These are the words of Rajendra Prasad, an Indian working in Sharjah, UAE, who has volunteered for Phase III human clinical trials.
Chinese state-owned pharmaceutical company Sinopharm had started Phase III clinical trials of a COVID-19 vaccine in UAE in mid-July itself.
A Phase II trial of the COVID-19 vaccine conducted in China was found that the vaccine is safe and induces an immune response. The results provide data from a wider group of participants than the Phase 1 trial, which was published in May. Phase 1 trial had involved 108 healthy adults and it demonstrated promising results.
And according to the state news agency, on August 13, the trials of the inactivated vaccine for COVID-19 in the UAE have reached 15,000 volunteers.
“15,000 targets have been achieved in less than a month with individuals from 107 nationalities and 4500 Emiratis participating in the programme,” the state news agency has added.
The Phase III human trial is a partnership between Sinopharm’s China National Biotec Group (CNBG), Abu Dhabi-based artificial intelligence and cloud computing company Group 42 (G42) and the Abu Dhabi Department of Health.
G42 is an Abu Dhabi-based artificial intelligence firm that has also partnered with Chinese genomics company BGI to build a COVID-19 testing laboratory in the Emirate, which is capable of conducting tens of thousands RT-PCR tests per day and is the first in the world of this scale to be operating outside of China.
Additionally, G42 has also tied up with Rafael Advanced Defense Systems and Israel Aerospace Industries to explore collaborations in the research and development of effective solutions to COVID-19.
Phase III considers the safety and effectiveness of the vaccine in a larger population sample and that is why it is being done in the United Arab Emirates.
Interestingly, Russia has also announced that trials of its COVID-19 vaccine, Sputnik V, will be conducted in UAE.
Speaking to The Lede, Rajendra Prasad, who volunteered for the Phase III trial on Tuesday said that people still have not realised the need for vaccines.
“They are frightened and anxious over the disease spread. They talk about it every moment. But they don’t volunteer when such trials are happening,” Rajendra Prasad, manager at NASCO, an insurance brokers firm in Sharjah, added.
“When I volunteered, my friends were discouraging me. My family was open and they supported me. And after all, this is once in a lifetime chance. I can tell my children that I was one of the volunteers who agreed for human trials. I am hopeful. This will vaccine is going to save the world,” Rajendra Prasad, who is from Telangana, said.
Rajendra Prasad was briefed by medics before the vaccine was administered. Following the briefing and signing of a consent form, the vaccine was administered on Rajendra Prasad. And he has to go for the second shot in 28 days.
“They have assured that they will do several follow-ups in different periods via telephone and I will also have to be present physically too. This will continue for 12 months. And in between if I fall sick, I will have to inform them too. I am happy to cooperate,” Rajendra Prasad added.
According to Rajendra Prasad, volunteers should be COVID-19 negative, aged between 18 – 60, and in good health.
“They took my swab and found that I am COVID-19 negative. So, they went ahead with administering the vaccination,” he added.
When asked about risks, Rajendra Prasad said that he had been told by the medics that some common reactions may occur when receiving the vaccine, including mild pain, redness, induration (a hardened mass), and pruritus (itchy sensation) at the vaccination site.
“But I didn’t experience anything,” he said, adding that the medics had assured him that even if there are mild systemic reactions such as fever and headache, they will subside on their own.
“And they had advised that any symptom should be reported to the trial centre,” he added.
A note from the trial centre, titled 4Humanity reveals that vaccines will be administered on 45,000 volunteers. Additionally, the firm has expanded the trial to Bahrain too.
In a race to find a vaccine that will protect people from the novel Coronavirus, six vaccines from around the world are now in phase three of human trials.
Meanwhile, in India, according to the Indian Council for Medical Research (ICMR), human clinical trials for a vaccine for COVID-19 have been initiated with approximately 1000 volunteers participating in the exercise for each of the two indigenously developed vaccine candidates.
The Drugs Controller General of India (DCGI) has permitted two vaccines – one developed by Bharat Biotech International Limited in collaboration with the Indian Council of Medical Research and another one by Zydas Cadila Healthcare to go in for the first and second phase of human clinical trials.