Russia’s Sechenov University has completed clinical trials of a coronavirus vaccine candidate developed by Gamaleya Research Institute of Epidemiology and Microbiology.
The Sechenov First Moscow State Medical University said the first group of volunteers who were administered with the newly developed vaccine candidate will be discharged this later week.
The group consisted of 18 volunteers. They were administered wit the vaccine in mid-June. Few days later, a second group comprising 20 volunteers were given the jab. The second group of volunteers is expected to be discharged by 20 July.
The volunteers involved in this clinical trial include both male and female. Their age group ranges between 18-65 years.
According to the university, the volunteers were administered a lyophilised vaccine, which is a powder from which a solution is made for intramuscular injection.
The Russian university reported that some of the volunteers in the clinical trial did experience headaches and increased body temperature, but their symptoms were fully resolved within 24 hours post-vaccination.
Alexander Lukashev, who is the director of Sechenov University’s Institute of Medical Parasitology, Tropical, and Vector-Borne Diseases, said that the goal of this stage of the clinical trial was to establish the safety of the coronavirus vaccine candidate in humans, which he claimed to be a success.
“The safety of the vaccine has been confirmed. It corresponds to the safety of those vaccines that are currently on the market.”
The same vaccine candidate from Gamaleya is also being studied at the Burdenko Military Hospital in Moscow. However, this clinical study is using the liquid form of the drug candidate.
Vaccine development is a multi phase process. In phase 1, the number of participants are small. It sees whether the vaccine is safe for humans or not. In phase 2, the number of participants are many and it involves to evaluating its efficiency. In the final phase, the vaccine is injected on thousands and its results are studied for months.
The clinical trial phase can last up to 18 months.
Adding the timeline for regulatory approvals any vaccine could takes upto three years before it hits markets. However, authorities around the world are fast-tracking potential vaccine trials in the light of the pandemic. Globally the target date is set for early 2021.