Russia has become the first country to have completed clinical trials of a Covid-19 vaccine candidate, after Sechenov University said that it had concluded its study.
According to Sechenov University Center for Clinical Research on Medications head and chief researcher Elena Smolyarchuk, study data showed the vaccine candidate’s effectiveness, reported Russian news agency TASS.
Smolyarchuk was quoted by the news agency as saying: “The research has been completed and it proved that the vaccine is safe. The volunteers will be discharged on 15 July and 20 July.”
The trial participants will be monitored on an outpatient basis after being discharged. Last month, Russia granted authorisation for clinical trials of two formulations of the Covid-19 vaccine candidate, which was developed by the Gamaleya National Research Center for Epidemiology and Microbiology.
An intramuscular solution of the vaccine was tested at the Burdenko Military Hospital while Sechenov University assessed the vaccine in the form of a powder for the preparation of an intramuscular solution.
The first stage of testing at the university commenced on June 18 in a group of 18 participants. The second group of the study involved 20 volunteers who were vaccinated on June 23.
Institute for Translational Medicine and Biotechnology director Vadim Tarasov was quoted by Russian news agency Sputnik as saying: “Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research center that is able to participate in the creation of such important and complex products as drugs…
“We worked with this vaccine, starting with preclinical studies and protocol development, and clinical trials are currently underway.”
Prior to the human trials, the vaccine was tested for its toxicity, safety, immunogenicity and effectiveness in large and small animals at the Russian Defence Ministry’s 48th Central research institute.
AU launches Covid-19 vaccine trial consortium
And the African Union Commission has introduced the new Africa Centres for Disease Control and Prevention (Africa CDC) Consortium for COVID-19 Vaccine Clinical Trial (CONCVACT).
CONCVACT is part of the Africa Joint Continental Strategy for tackling Covid-19. The goal is to prevent severe Covid-19 illness and deaths in the African Union Member States, reduce social disruption, and minimise the economic consequences of the pandemic.
A vaccine is expected to limit transmission, prevent deaths, and support socio-economic recovery in Africa. South Africa President Cyril Ramaphosa said: “Success in developing and providing access to a safe vaccine requires an innovative and collaborative approach, with significant local manufacturing in Africa.
“We need to support the contribution of African scientists and healthcare professionals. We need to act with urgency.”
CONCVACT plans to secure more than ten late-stage vaccine trials at the earliest via collaborations with global vaccine developers and funders, and African firms that enable clinical studies.
The consortium hopes to capture the safety and efficacy data of promising vaccine candidates for the African population in order to validate their launch after approval. It will establish an independent review board for guidance, assistance and oversight of trials, as well as work to increase public awareness on clinical testing in the continent.
African Union Commission Social Affairs Commissioner Amira Elfadil Mohammed said: “There is urgent need for global solidarity, cooperation, and appropriate regulation to ensure equitable access to potential Covid-19 vaccine.
“The African Union will continue to partner with GAVI, WHO and other relevant stakeholders in the development of Covid-19 vaccine.”
Last month, the University of Witwatersrand in South Africa collaborated with the UK’s University of Oxford and the Oxford Vaccine Group to evaluate a Covid-19 vaccine candidate developed at the UK university.
This marks South Africa’s first trial of a vaccine against Covid-19. If the vaccine trial is successful, Africa expects a Covid-19 vaccine to be available in the first quarter of next year, reported Reuters, citing a University of Witwatersrand professor.