Russia on Wednesday officially launched a vaccine that could arguably be the world's first COVID-19 treatment system, according to multiple news reports.
Russia has over 8 lakh confirmed cases of coronavirus, the fourth-worst hit in the world, behind the USA, Brazil and India. In addition to Gamaleya, the Vektor State Research Centre of Virology and Biotechnology is also working on a potential vaccine.
The vaccine candidate, 'Gam-COVID-Vac Lyo' developed by Moscow's Gamaleya Institute with help of Russian Direct Investment Fund, will likely get approval for civilian use within three to seven days of registration by regulators, a Bloomberg report said.
Earlier in August, Russian Health Minister Mikhail Murashko told reporters that the clinical trials of the vaccine were over, and that he hoped that serial production of the vaccines would start in September.
But the institute has not disclosed any data about the results of the phase 2 and the phase 3 trials, which are intended to test for any drug's efficacy and safety, respectively.
The World Health Organisation has data on the Russian vaccine till only its Phase 1 trial. The WHO has urged Russia to follow the standard operating procedures to produce a 'safe and effective vaccine'.
The lack of clarity on the processes followed in the launch of the vaccine has triggered concerns among experts globally.
In a report by Bloomberg, Svetlana Zavidova the Executive Director of the Association of Clinical Trials Organizations said. “Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated."
“This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine,” she added.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States cautioned in an NYT report, “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone."
In fact, in July, Bloomberg reported that Russian elites had been administered the Gamaleya vaccine as early as in April "at their own risk".
Usually, development of vaccines takes years or even decades but the rapid coronavirus outbreak has resulted in the global medical fraternity scrambling to crunch timelines by fast-tracking approvals and investing large amounts of money.
Still, the pace at which Russia claims to have developed a fully functioning vaccine has given rise to concerns over, what Trial Site News website called, "vaccine nationalism", or a COVID-19 arms race.
The website estimated that since Phase 1 was completed not much more than a month ago, the vaccine should ideally have been in Phase 2, and "that the Russians could be fast-tracking their primary national vaccine so that it will be approved without completing a pivotal Phase 3 clinical trial."
"Remember, Phase 3 clinical trials evaluate the safety and efficacy of an intervention in large-scale populations. As an example, companies such as Moderna, Pfizer/BioNTech, and AstraZeneca (Oxford) are conducting large Phase 3 trials with up to 30,000 volunteers per study. These trials can take months, if not years, to complete," it added.
On their part, Nikolay Briko, Russian Health Ministry’s chief non-resident epidemiologist, said the the vaccine wasn't developed from scratch and hence it was possible to launch it in such a short time.
"The Gamaleya Research Center had a serious, significant research base on vaccines. The technology of developing such a vaccine was perfected. So perhaps, the process was sped up due to the fact that the vaccine was not created from scratch," Briko told the TASS news agency.
First Published: IST