China to initiate phase 3 SARS-CoV-2 vaccine trial in UAE

By Angela Betsaida B. Laguipo, BSNJun 26 2020

The race in finding an effective vaccine against the novel coronavirus is very much on. With more than 9.58 million people having been infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), finding a vaccine is of utmost importance.

Now, China is ready to run its large-scale phase III clinical trial of its novel coronavirus candidate in the United Arab Emirates (UAE). Over a dozen experimental vaccines are being trialed across the globe, but China’s vaccine is the first one to proceed to phase III human trials.

Novel Coronavirus SARS-CoV-2: This scanning electron microscope image shows SARS-CoV-2 (round gold objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S. Credit: NIAID-RML

Joint efforts

China National Biotech Group Co. (CNBC) was approved to run its phase III trial for its coronavirus disease (COVID-19) vaccines in the UAE. The firm will collaborate with an Abu Dhabi-based artificial intelligence and cloud computing company, G42.

The company spearheaded the launching ceremony of Sinopharm China National New Crown Inactivated Vaccine International Clinical (Phase III) simultaneously in Beijing, Wuhan City, and Abu Dhabi in the UAE. The participants attended the launch via video conferencing.

During the ceremony, the UAE Minister of Health and Prevention, Abdul Rahman Mohammed Al Owais, issued a phase III of the COVID-19 inactivated vaccine clinical approval certificate to Ni Jian, the Chinese Ambassador to the UAE. Meanwhile, Dr. Ali Obaid Al Dhaheri, the UAE Ambassador to China, issued the clinical approval of the vaccine to the Chair of CNBG, Yang Xiaoming.

The phase III trial of a vaccine will involve thousands of participants and usually occurs in a country where the virus is widespread, so the vaccine’s efficacy can be seen in real-life situations. With China’s cases declining over the past months, the country looked for other countries where it can test its vaccine.

CNBG announced the collaboration in a social media post in Weibo, without naming the vaccine to be tested.

What happens in a phase III trial?

The inactivated vaccine developed by the Wuhan Institute of Biological Products under CNBG, have already been tested on about 2,000 people in phase I and phase II trials in China.

The results show that having two injections of the vaccine produced high titers of antibodies, which are vital in fighting off the coronavirus infection. In fact, for the patients who received two injections at an interval of 28 days, the seroconversion rate of neutralizing antibodies reportedly reached 100 percent. The results of the other vaccine’s efficacy are to be released on June 28.

The clinical research of vaccines is typically divided into three phases – phase I, phase II, and phase III. The initial phase will determine the safety of the vaccine, while phase II will evaluate the safety and immunogenicity of the vaccine. The last phase will assess the safety and efficacy of the vaccine in a larger population.

In a vaccine’s phase III trial, thousands of people participate to help scientists determine any possible adverse effects. Once a vaccine is proven effective and safe in this phase, the trial will be deemed successful, and the vaccine can then enter large-scale manufacturing phase.

The company’s senior executives and more than 1,000 employees already received the shots. The employees were given voluntary vaccines if they will travel abroad or if they live in high-risk locations in Beijing, which has reported a recent spike of coronavirus cases.

Other companies in China are seeking to trial their vaccines abroad, including Clover Biopharmaceuticals and Sinovac Biotech, which is expected to commence its phase III trial in Brazil, with about 9,000 volunteers.

The coronavirus disease is still ravaging across the globe, with millions infected and at least 488,000 dead. The United States and Brazil record the highest numbers of infections, with 2.42 million and 1.22 million cases, respectively.

Many countries, especially those with poor health systems, grapple with the skyrocketing cases of the viral infection. The only hope is to find an effective vaccine or treatment that can stop the spread of the deadly virus.

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