By Emre Aytekin
ANKARA (AA) - A coronavirus vaccine developed by German firm BioNTech, whose co-founder is Turkish scientist Dr. Ugur Sahin, has started trials on humans in China after Germany and the US.
Shanghai-based Fosun Pharma drug company started the first phase of clinical trials of the vaccine, called BNT162b1, according to Clinical Trials Arena, a website that focuses on reporting drug development and research process.
First doses have been injected into 72 subjects to test the reliability and immunity effect. A total of 144 healthy participants will be enrolled in the country.
The first stage of the trial will involve volunteers aged 18 to 55, followed by elderly healthy participants aged above 55.
The subjects will be given two doses of 10 or 30 micrograms or placebo, 21 days apart.
During the clinical development, BioNTech will deliver the clinical supply of the vaccine from its mRNA manufacturing facilities in Europe.
Production rights of the vaccine have been bought by the US Pfizer, and Chinese Fosun Pharma companies.
The vaccine’s first and second phase of clinical trials yielded positive results in Germany and the US, and the third phase of trials started on July 27 in the US.
The vaccine is planned to be tried on 30,000 volunteers around the world.
- India starts Phase II trial
Meanwhile, India-based Zydus Cadila has launched Phase II clinical trials of locally produced ZyCoV-D vaccine.
The vaccine was found to be safe in the first phase and well-tolerated in healthy participants.
In the second phase, the vaccine is planned to be tried on 1,000 healthy adults.
The potential vaccine, developed in the Vaccine Technology Center of the company in Ahmedabad, was tried on animals and yielded "strong immunity response" in various animal subjects, according to the company.
Drugs Controller General of India (DCGI) approved the vaccine to be tried on humans on July 3. Apart from Zydus Cadila, another company called Bharat Biotech also conducts vaccine development work.
- Clinical trials are done on 3 phases
In order for a vaccine to be used on humans, it should be tested on humans in 3 different phases.
In the first phase, it is tried on a small number of healthy volunteers in order to find out if it is safe and if it has any side effects.
In the second phase, having confirmed its safety, the vaccine is tested on more than 100 subjects.
In the third and last phase, the same procedure is repeated thousands of times.
This whole process might take months, even years.
- 27 potential vaccines are on clinical trial phase
By July 31, some 27 potential COVID-19 vaccines are being tested around the world, while some 139 vaccines are in the development phase pre-trial, according to WHO data.
Since appearing in China last December, the virus has spread to at least 188 countries and regions, according to figures compiled by the U.S.-based Johns Hopkins University's Coronavirus Resource Center.
More than 19.14 million cases of COVID-19 have been confirmed worldwide, with over 715,800 deaths, and nearly 11.6 million recoveries.