Candidate: Sputnik V
Category: VAX
Type: Vaccine consisting of two components, administered 21 days apart: Component 1 consists of a recombinant adenovirus vector based on the human adenovirus type 26, containing the SARS-CoV-2 S protein gene. Component 2 consists of a vector based on the human adenovirus type 5, containing the SARS-CoV-2 S protein gene. Both components are designed to enter human cells and produce an immune response. Immunity to SARS-CoV-2 will last for two years, according to Mikhail Murashko, Minister of Health of the Russian Federation.
2021 Status: Dr. Reddy’s Laboratories said January 15 that it received approval from the Drugs Control General of India (DCGI) to conduct a Phase III trial for Sputnik V in India. The randomized, double-blind, parallel-group, placebo-controlled study will recruit 1,500 participants, and be conducted in India. Earlier, the trial’s Data and Safety Monitoring Board (DSMB) recommended the trial advance to Phase III after concluding that no safety concerns were raised in a Phase II study that met its primary endpoints of safety.
As of January 15, clinical trials for Sputnik V were underway in the UAE, Egypt, Venezuela, and Belarus while the vaccine had been registered in Algeria, Argentina, Belarus, Bolivia, and Serbia.
2020 Status: The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) said November 13 it would partner with South Korean biotech company GL Rapha and subsidiary Hankook Korus Pharm to produce over 150 million doses per year of Sputnik V. RDIF and GL Rapha said they will supply over 150 million vaccine doses per year produced in South Korea for global distribution. The partners intend to commence production in December 2020 and roll out Sputnik V in January 2021.
Requests for more than 1.2 billion doses of the Sputnik V vaccine have been received from over 50 countries, RDIF said. The vaccine supplies for the global market will be produced by RDIF’s international partners in South Korea, India, Brazil, China, and other countries.
Dr. Reddy’s Laboratories and RDIF said October 17 they received approval from the Drug Control General of India (DCGI) to conduct an adaptive Phase II/III human clinical trial for Sputnik V vaccine in India. The multi-center, randomized controlled study will include a safety and immunogenicity study. Dr. Reddy’s and RDIF agreed in September to conduct clinical trials of Sputnik V and oversee its distribution in India. Under the partnership, whose value was not disclosed, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India.
Russia’s Ambassador to Japan, Mikhail Galuzin, has promoted Sputnik V in visits to the Japanese cities of Kasumigaseki and Nagatacho, The Japan Times reported on October 7: “We have started production of the world’s fastest developed coronavirus vaccine. Please try using the Russian vaccine.”
Mexico’s Foreign Minister Marcelo Ebrard said August 25 his country had agreed to allow 2,000 Mexican volunteers to take place part in trials of Sputnik V.
Russian president Vladimir Putin declared August 11 that his country’s regulators gave the world’s first regulatory approval to a COVID-19 vaccine that was developed by Gamaleya Research Institute of Epidemiology and Microbiology, run by the Health Ministry of the Russian Federation, despite the vaccine having no known Phase III trials according to the World Health Organization. Former FDA Commissioner Scott Gottlieb, MD, tweeted that the approval “may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines.”
Gottlieb and other observers also noted the low number of participants in the limited clinical study of the vaccine. According to ClinicalTrials.gov, Sputnik V (under its old name of Gam-COVID-Vac) was tested in an open, two-stage, non-randomized Phase I/II trial (NCT04436471) that recruited just 38 participants, all healthy volunteers. The study’s primary outcome measures were the change in antibody levels against the SARS-CoV-2 glycoprotein S in 42 days; and the number of participants with adverse events.
The vaccine’s fast regulatory track prompted the resignation of Professor Alexander Chuchalin from the Russian Health Ministry’s ethics council. Chuchalin told Mail Online he challenged the two leaders in development of Sputnik V, Professor Alexander Gintsburg, Director of the Gamaleya Institute, and Professor Sergey Borisevich, a medical colonel and the Russian army’s top virologist: “Have you passed all the necessary paths approved by the Russian Federation legislation and the international scientific community? This job has not been done. Thus, one of the ethical principles of medicine has been grossly violated—to do no harm.”
Putin insisted the vaccine was safe: “I know that it works quite effectively, forms a stable immunity and, I repeat, has passed all the necessary tests.”
Putin also disclosed that one of his daughters had volunteered to take the vaccine, named for the first artificial Earth satellite that touched off the Cold War “Space Race” when launched in 1957 by the Soviet Union. She was said to have shown no side effects: “After the first vaccination, her temperature was 38 [degrees Celsius], the next day—37 with a little and that’s it. . . . After the second injection, the second vaccination, the temperature also rose a little and then disappeared,” Putin said in remarks reported by the state-owned RIA Novosti news agency.
Gintsburgh told the Rossiya-1 television channel on August 16 that U.S. and European institutions had attempted to “poach” Gamaleya Institute researchers without success: “I would call it a natural negative reaction of Western companies to the emergence of a Russian production they did not expect. So, I think we should ignore these negative things that are being poured on us.”
Kirill Dmitriev, CEO of the $10 billion Russian Direct Investment Fund (RDIF), told the state-owned TASS news agency that clinical trials of Sputnik V were expected as of August 11 to start “soon” in the United Arab Emirates and the Philippines, where President Rodrigo Duterte has publicly expressed willingness to personally take the vaccine.
Dmitriev added 20 countries in Latin America, the Middle East, Asia, and elsewhere had requested to purchase from Russia a combined 1 billion doses. Manufacturing capacity was in place to produce 500 million doses, with plans for expansion, he added.
The vaccine will be administered to medical personnel, and then to teachers, on a voluntary basis by early September, with a mass roll-out in Russia expected to start in October, according to Reuters—though RIA Novosti said civil circulation of Sputnik V will start January 1, 2021, citing the state register of medicines of the Ministry of Health. The vaccine is to be produced at two sites: at the Gamaleya Center, and at the manufacturing site of Binnopharm.
Sputnik V underwent preclinical testing at the Gamaleya Center and 48 research institutes of the Ministry of Defense, followed by clinical studies at the Sechenov University and the branch of the Burdenko Main Military Clinical Hospital, RIA Novosti reported.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
