Large-scale trials of approved Covid-19 vaccine will begin next week in Russia, involving over 40,000 people, according to The Independent.
After two months of small-scale human trials, Russian scientists proclaimed the vaccine, Sputnik V, safe and effective.
Sputnik V developed by Moscow’s Gamaleya Institute became the first licensed Covid-19 vaccine, receiving approval from domestic regulators after it has been tested on just 76 people.
“A vaccine against coronavirus has been registered for the first time in the world this morning,” said Putin. “I know that it works quite effectively, it forms a stable immunity,” he added.
The vaccine was registered ahead of the large-scale trials (Phase III) experts regard as an essential step before the registration.
Phase III studies comprise of randomized and blind testing in several thousand subjects.
Western experts urge internationally approved testing is needed before the use of the vaccine.
A foreign research body will supervise the next week’s mass testing carried out at more than 45 medical centres around Russia to confirm the data collection complies with international standards.
The collected data will be shared with the World Health Organisation.
Catherine Smallwood, a senior emergency official at WHO Europe, said WHO is aiming for an “accelerated approach” with the development of Covid-19 vaccines.
Kirill Dmitriev, head of the Russian Direct Investment Fund backing the vaccine development, said the results of the trials would be disclosed this month in an academic journal.
United Arab Emirates, India, Brazil, and several other countries are contemplating participating in the late-stage trials.
Russia is currently able to manufacture 500 million doses per year but has already recorded requests for up to a billion doses of the vaccine from all parts of the world.
Presumably, the vaccine can be distributed widely only in January 2021 after the completion of the larger clinical trials, but Russian doctors and vulnerable groups could begin getting vaccinated already this month.
Scientists worldwide are working on more than 165 Covid-19 vaccines from which 32 vaccines are in human trials.
At least eight other prospective SARS-CoV-2 vaccines are in Phase III trials.
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