The Russian government has announced plans to begin a nationwide vaccination campaign in October, despite mounting questions over its Covid-19 vaccine and a lack of crucial data confirming its effectiveness.
The minister of health, Mikhail Murashko, told the state news agency RIA on Saturday that early-stage clinical trials for a candidate from the Moscow-based Gamaleya Institute had been completed, with regulatory approval likely to be secured this month.
Mr Murashko added that teachers and health care workers in Russia would be the first to be inoculated.
Mass production for the Gamaleya vaccine, which will be handled by a developer across three locations in central Russia, is expected to begin in September, according to industry minister Denis Manturov.
“We are very much counting on starting mass production in September,” he told Russian news agency Tass. “We will be able to ensure production volumes of several hundred thousand a month, with an eventual increase to several million by the start of next year.”
Russia will now start large-scale Phase 3 trials of the vaccine to determine its efficacy within the wider population, said Kirill Dmitriev, a senior official with Russia Direct Investment Fund, a government-controlled investor in the country’s vaccination efforts.
Addressing the speed at which the country has moved in developing a vaccine, Mr Dmitriev said: “It’s a Sputnik moment for many people who didn’t expect Russia to be the first.”
Moscow says the Gamaleya vaccine has generated an immune response in all subjects, with no serious complications. But already there are doubts about advertised safety. One group of volunteers selected from the military reported no side effects whatsoever – but another, selected from medical students at a Moscow university, reported fevers above 38C.
Although the mechanism for the candidate has been described, no data on its safety or effectiveness has been published after volunteers were given the vaccine in June.
Russia’s vaccination efforts have been met with scepticism from the international community, amid concerns over missing data and the country’s testing methods.
Soldiers were used as volunteers for the Gamaleya vaccine, raising ethical questions about consent, while the institute’s director, Aleksandr Gintsberg, admitted in May that he and other researchers had injected themselves with the early prototype.
Dr Anthony Fauci, chief coronavirus advisor to US president Donald Trump, warned last week: “I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone.
“I do not believe that there will be vaccines, so far ahead of us, that we will have to depend on other countries to get us vaccines.”
Tedros Adhanom Ghebreyesus, head of the World Health Organisation, has also called for caution over the efficacy of new vaccines.
“A number of vaccines are now in phase three clinical trials and we all hope to have a number of effective vaccines that can help prevent people from infection. However, there’s no silver bullet at the moment - and there might never be,” he said.
The WHO maintains a comprehensive list of vaccine trials currently underway across the globe, yet this does not include a Russian Phase 3 trial for the Gamaleya candidate.
Russia has the fourth-highest number of Covid-19 infections in the world, according to Johns Hopkins University data, with over 854,000 people having tested positive. More than 14,000 have died from the disease, while around 649,000 have recovered after contracting the disease.