Two indigenous candidate vaccines for COVID-19 have got DCGI clearance to start early phase human trials in the country, the Indian Council of Medical Research (ICMR) said on Tuesday.
In the phase of trials, the company will be enrolling over 1,000 subjects across multiple clinical study sites in India, it said in a regulatory filing.
The report, citing Citing Alexander Lukashev, the director of the Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases at Sechenov University, said the study has been conducted to check the COVID-19 vaccine's safety when given to humans and it has been successfully completed.
Russia's Sechenov University: Russia made headlines on Sunday after it said that the first phase of the clinical trial has proved to be successful. BioNTech SE and Pfizer Inc's Covid-19 vaccine candidate is expected to be ready by the end of 2020.
The Food and Drug Administration has said that any COVID-19 vaccine would need to prevent illness or decrease the severity of the disease in 50 percent of people who receive it in order to be approved.
The authors of the study, however, noted that they were unable to say how long that immune response lasted, a crucial question when weighing the effectiveness of a vaccine. However, the institute has selected only 18 volunteers between the age group of 18-55 years.
Canada's economy added 953000 jobs in June - RCI | English
In June, employment was still down 9.2 percent from February before the World Health Organization declared the global pandemic. Market expectations were for an increase of 550,000 jobs in June, according to economists from National Bank Financial.
India's COVID-19 tally is close to hitting the one million mark, with new cases pushing the total number to 93,6181 on Wednesday.
The official said one silver lining of current outbreaks is that it is allowing tens of thousands of people to participate in clinical trials needed to test the vaccines, some of which are set to enter phase three trials within a few weeks. Almost 150 potential COVID-19 vaccines are being tested around the world, according to the World Health Organization (WHO).
Moderna had previously published "interim results" from the first stages of its trial, called Phase 1 in May.
The Russian university claims all human trials of the vaccine have been completed, but, only 40 volunteers were involved in the clinical trial.
However, more than half of the participants reported fatigue, headache, chills, myalgia or pain at the injection site.
Oxford University scientists who were working on this coronavirus vaccine had earlier on said that the vaccine may only have a 50-per-cent chance of success. According to the same World Health Organization document, the only vaccine candidates to have reached Phase III trials were the University of Oxford/Astra Zeneca's and China's Sinovac's.