Russian vaccines against COVID-19 currently clinically trialed

Russian vaccines against COVID-19 currently clinically trialed  

In June 17, 2020 Russian Ministry of Health’s representative reported that anti-COVID-19 vaccines entered a clinical trial phase in FSBI Research Center for Epidemiology and Microbiology named after N.F. Gamalei. Clinical Trial approval was obtained the day before.

Two vaccine types were reported to be approved for the clinical trials; first one is of a solution dosage form and will be IM-injected. It’s efficacy will be studied by the Burdenko hiospital. Another one is formulated as powder and will be studied in the Sechenov’s Medical University.

2 groups of healthy volunteers are planned, 28 subjects in each.

Ministry of Health’s representative states that “clinical study of the vaccine within the pandemic period is a unique case. Therefore we arranged the following: healthy volunteers candidates were thoroughly assessed by the medical specialists within two weeks”.

On 18 and 19 June 2020, first volunteers were vaccinated and then hospitalized for 4 weeks. Within this period study staff controlled their general health state and performed blood sampling. Based on the results study staff will control immunological response in vaccinated people; further on, half-year follow-up should be performed.

Ministry of Health’s representative states that all the clinical trials are compliant with all the legislation and regulatory norms and studied in duly accredited study sites having all the necessary facilities and equipment, intensive care unit and anti-anaphylaxis means. 

"The whole process of the vaccine clinical trials does not affect the rights of its participants or injure their health. Voluntary participation in the trials is the crucial point here, since each participant independently makes a choice: to participate or not," the Ministry reported.

It was also noted that this whole procedure is only the first stage in the study of the effectiveness and safety of the developed vaccines.

It was also noted that this is the first stage of the vaccines’ efficacy and safety study.

For more information of clinical trials’ stages please see the following article.