Chinese COVID-19 vaccine registered in UAE with 86% efficacy, no serious safety concerns
By Hu Yuwei Source: Global Times Published: 2020/12/9 16:53:53 Last Updated: 2020/12/9 22:43:45
Chinese-developed inactivated COVID-19 vaccine has shown 86 percent efficacy against the virus, the United Arab Emirates (UAE) health ministry said on Wednesday, based on their interim analysis of Phase-III clinical trials.
"It is a significant and very positive indicator of the vaccine's effectiveness," a source close to the vaccine producer Sinopharm told the Global Times on Wednesday. "The UAE government adopts internationally recognized criteria for clinical trials, which indicates that our data are recognized by a third party."
The UAE's Ministry of Health and Prevention (MOHAP) has announced the official registration of the inactivated COVID-19 vaccine candidate developed by Sinopharm in a remarkable step to combat the deadly virus.
The Sinopharm has submitted the experimental data and results of late-stage trials to both Chinese and UAE regulators around the same time, and the Chinese regulator is still in the process of assessing the results, according to the source.
UAE regulator's analysis also shows the vaccine to have 99 percent seroconversion rate of neutralizing antibody and 100 percent effectiveness in preventing moderate and severe cases of the disease. Furthermore, the analysis shows no serious safety concerns, the Emirates News Agency reported on Wednesday, saying the announcement is a significant vote of confidence by the UAE's health authority in the safety and efficacy of this Chinese-developed vaccine.
China's national COVID-19 vaccines administration guidelines issued on August 14 require the vaccine protection rate of at least 70 percent and no lower than 50 percent if they request official registration, the same as the standard of the US Food and Drug Administration. Sinopharm's vaccine has surpassed that standard. In fact, the efficacy rate at 86 percent is far higher than the minimum standard.
US pharmaceutical giants Pfizer and Moderna had previously released their mRNA vaccine candidates' protection rates in November through their own channels that were not presented in detail.
Sinopharm's late-stage vaccine trials had the largest number of participants with more than 50,000 volunteers, higher than those of Pfitzer (over 43,000) and Moderna (30,000). However, it is not necessary to compare different vaccine candidates as they are developed using different technologies and have different designs of the experiment and expected number of infections, said the source from the Sinopharm.
The UAE in September granted emergency approval for the use of the Sinopharm vaccine candidate. The vaccine will be available to the frontline medical workers who are at the highest risk of contracting the virus, in order to protect them from any dangers and provide safety precautions, according to the UAE authority.
Phase-III clinical trials of the vaccine kicked off in the UAE on July 16, which was the world's first Phase-III clinical trial program for a COVID-19 candidate vaccine.
It had been administered to 31,000 volunteers representing 125 nationalities since the start of the clinical trials in the UAE. Mild and anticipated side effects had occurred but no severe side effects had been encountered, according to the authority in September.
Clinical trials of the vaccine tested in the UAE are also being conducted in Bahrain, Jordan and Egypt at the same time, Ashish Koshy, chief executive officer of Sinopharm's UAE trials co-developer Group 42 (G42) Healthcare, told the Global Times in a previous written response.
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