The trial is set to get underway in that country by the end of this month.
July 2020 saw R-Pharm sign a licensing deal with AstraZeneca to produce and distribute doses of its adenovirus-based COVID-19 shot. Under that deal, R-Pharm would export the Oxford-AstraZeneca vaccine to markets in the Commonwealth of Independent States (CIS), a nine-country economic group including Russia and post-Soviet republics, the Middle East and the Balkans.
Both vaccines involve two doses, an initial shot and a booster, and use harmless adenoviruses as vehicles, or vectors, to carry genetic instructions into the body to prompt cells to produce antibodies. Sputnik, however, uses different viral vectors for its two shots.
The Azerbaijan trial is just one of many set to run under a clinical research program announced in December last year, involving several countries, and a number of partners.
The Russian Direct Investment Fund (RDIF), which is Russia's sovereign wealth fund, the Gamaleya National Center, which developed the Sputnik V vaccine, AstraZeneca and Russian drug maker, R-Pharm, reported at the end of 2020 that they had signed an agreement aimed at the development and implementation of a clinical research program to assess the immunogenicity and safety of the combined use of one of the components of the Sputnik V vaccine and one of the components of Oxford-AstraZeneca vaccine.
In relation to today's developments, Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF), said: “We need to join our international efforts and use the most advanced solutions to defeat the coronavirus. A publication in the leading peer-reviewed medical journal, The Lancet, showed Sputnik V to be 91.6% efficacious. It is only one of three vaccines in the world with efficacy over 90%. We are ready to develop cooperation with other manufacturers to increase the number of affordable and effective drugs.”
Alexey Repik, the R-Pharm Chairman of the Board, also weighed in, saying: “R-Pharm has been actively working with the Republic of Azerbaijan for several years, we opened a modern production facility here in 2019, later, in 2020, we registered two drugs from our anti-COVID portfolio: Artlegia and Coronavir. This pilot study is vital for developing a new approach to the prevention of COVID-19; moreover, the leading scientific and clinical centers of Azerbaijan will be able to make their own important contribution in this direction.”
Sputnik V vaccine
The Sputnik V vaccine combines two different vectors based on human adenovirus, which the developer claims allows for a stronger and longer-term immune response compared to vaccines using the same vector for two shots.
“This regimen is one of the reasons why the vaccine shows efficacy of over 90%, with full protection against severe cases. Among the leading COVID-19 vaccines only Sputnik V is using the two different vectors technology.”
COVID-19 Vaccine AstraZeneca
Developed by the Oxford University in conjunction with Vaccitech, the Oxford-AstraZeneca vaccine uses a replication-defective chimpanzee viral vector based on an attenuated version of the common cold virus (adenovirus) that causes infection in chimpanzees and contains genetic material from the SARS-CoV-2 spike protein.
After vaccination, the surface spike protein is synthesized, which leads to the formation of an immune response to SARS-CoV-2 with possible subsequent infection with this virus.
UK trial also looking at combining approved vaccines
Oxford University last week announced that it was involved in a trial, backed by UK government funding to the tune of £7m (US$9.5m), looking at whether inoculating volunteers with doses of different combinations of two currently approved COVID-19 vaccines, would be effective. The idea is to hopefully provide for flexibility in COVID-19 vaccination delivery.
The organizers want to test a first dose of the Oxford-AstraZeneca vaccine followed by boosting with either the Pfizer vaccine or a further dose of the Oxford-AstraZeneca vaccine, or a first dose of the Pfizer vaccine followed by boosting with either the Oxford-AstraZeneca vaccine or a further dose of the Pfizer one.
Two different dosing schedules will be evaluated in the trial: at a four-week interval for an early interim data readout and at a 12-week interval for comparison to current UK policy.
Already recruiting, the organizers are focusing on enrolling people aged 50 years and above who have not yet received a COVID-19 vaccine.