Editor's Note: This story was first published on 6 August 2020 and has been republished due to the launch of the vaccine tomorrow. It has also been editing to include some concerns of the Association of Clinical Trials Organizations
In a race to find a vaccine that will protect people from the novel coronavirus, six candidates from around the world are now in phase three of human trials. Recent reports from Russia claim that one of their candidates has completed all three phases of human clinical trials successfully. Russia will reportedly begin producing the vaccine soon and already has plans for a massive, country-wide vaccine drive.
Russia currently has two COVID-19 vaccine candidates in the race – one, a vaccine being developed by the Vektor State Research Center of Virology and Biotechnology. The second is a vaccine being produced by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian Defence Ministry.
As of 1 August, TASS reported that human trials of the Gam-COVID-Vac Lyo – the vaccine candidate from the Gamaleya Scientific Research Institute – are now complete. The process of registering the vaccine will begin as early as 10 to 12 August. The vaccine will then be made available 'within three to seven days of registration', as per a Bloomberg report.
"Clinical trials of a coronavirus vaccine developed by the Gamaleya centre are over, paperwork is underway for the vaccine’s registration," Russian Health Minister Mikhail Murashko pointed out in the report.
The human trials of the Gam-COVID-Vac Lyo – the vaccine candidate from the Gamaleya Scientific Research Institute – are now complete.
TASS reports that the head of the Russian Direct Investment Fund (RDIF) Kirill Dmitriev said the people who were injected with Gam-COVID-Vac Lyo have developed immunity on the 21st day after receiving the first dose. He said that their immunity has doubled after they received the second injection.
"I can tell you, from first and second phase we have a hundred percent of people developing immunity after day 21. It doubles after the second shot. Hundred percent of animals were also protected (against the novel coronavirus)," Dmitriev said.
However, it was only on 13 July that the reports came out with Russia claiming that their two-part phase I trial was a success.
Russia has not published any findings from its vaccine trials. The World Health Organisation has been tracking various COVID-19 candidates and has made no mention of the vaccine clearing all three phases of human trials. Health experts are worried that Russia is cutting corners and fast-tracking the process putting the people at risk. The WHO also stepped in and has urged the country to follow the established guidelines to produce a 'safe and effective vaccine'.
WHO spokesman Christian Lindmeier said at a press conference, "Sometimes individual researchers claim they have found something, which is of course, as such, great news. But between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference."
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases in the United States cautioned, “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone."
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.
"Vaccines that are not properly tested can cause harm in many ways — from a negative impact on health to creating a false sense of security or undermining trust in vaccinations," Thomas Bollyky, director of the global health program at the Council on Foreign Relations told The Associated Press.
On 2 August, Chief of Russia’s sanitary watchdog Anna Popova tried to reassure everyone in an interview on the Rossiya-1 television channel by saying, "I have no doubts that the vaccine (against the novel coronavirus) that is to reach people will be absolutely safe and, of course, efficient."
"I would like to hope that the (immunity) will be sustainable and lasting," she added.
The Russian Defence Ministry also stepped in to clarify that it "tests the vaccine on volunteers in full compliance with the acting legislation and scientific methodological regulations, in order to prevent further risks, without any attempt to reduce the duration of the research."
Production of vaccine to begin
A Reuters report, citing an anonymous source, said that Russia's first potential vaccine will be approved by regulators this month. Production of this vaccine is all set to begin September.
Industry and Trade Minister Denis Manturov said in an interview with TASS said "The Gamaleya Institute is working on serial production with three enterprises with facilities in the Vladimir, Yaroslavl and Moscow regions, those are Generium, R-Pharm and Binnopharm... We very much hope that serial production will start as early as in September."
While no exact numbers were given, Manturov said that 'several thousands of doses' will be produced each month this year. By 2021, Russian companies will produce 'several million' doses of the Gamaleya National Research Institute of Epidemiology and Microbiology vaccine.
Illustration of vials of COVID-19 vaccine. Image credit: Flickr/Jernej Furman
Dmitriev, in an interview with the Rossiya-24 TV channel, said that more than 20 countries from around the world have shown interest in producing the Russian vaccine.
"Our foreign partners express great interest in producing this vaccine in their countries. There is great interest from Brazil, from India, from many other countries that are very much looking forward to the Russian vaccine, the first vaccine in the world," Dmitriev told TASS.
"And more than five countries are now actively working with us to start producing the Russian vaccine," he added.
Mass vaccination by October
On 1 August, Health Minister Murashko said that Russian plans on starting a mass vaccination campaign against the novel coronavirus in October. According to a report by Livemint, the vaccine will be first given to doctors and teachers.
"We plan wider [vaccination] for October because we need to launch a new system of treatment gradually," Murashko said according to a report by TASS.
The vaccine will also be 'free of charge' and the cost will be taken from the country's budget.
Vektor vaccine
The EpiVacCorona vaccine being produced by the Vektor State Research Center and the Biotechnology of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing recently announced that they will begin mass production of the vaccine in November.
They had begun their human trials on 24 July and as of 4 August 2020, only three volunteers out of five have been vaccinated with the fifth volunteer getting the first dose yesterday, 5 August. The age from 18-30 years. The EpiVacCorona doses will be administered again after 21 days.
According to the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Russia is developing 26 additional coronavirus vaccine candidates at 17 research institutions. Murashko said that in the next six to eight weeks, developers of two other vaccines will put in their permission request to start clinical trials on volunteers.
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source https://www.firstpost.com/health/russia-launch-worlds-first-covid-19-vaccine-tomorrow-12-august-need-know-8679581.html
