Russia approves first vaccine but scientists wary
Putin hails breakthrough and claims it was tested on his daughter but doubts persist over transparency
Vladimir Putin said yesterday that Russia had approved the world’s first Covid-19 vaccine, underlining his faith in the drug by saying it was tested on one of his daughters. Moscow hailed its speedy development, but scientists questioned a lack of testing and transparency.
VLADIMIR PUTIN said yesterday that Russia had approved the world’s first Covid-19 vaccine, underlining his faith in the drug by saying it was tested on one of his daughters.
Moscow hailed its speedy development as evidence of Russia’s medical prowess, but scientists questioned a lack of testing and transparency.
Speaking at a government meeting on state television, the Russian president said the vaccine, developed by Moscow’s Gamaleya Institute, was safe. “I know it works effectively, forms strong immunity, and it has passed all the needed checks,” he added.
He said his daughter had a temperature of 38C on the day of the first vaccine injection, but it dropped to 37C the following day. “She’s feeling well, and has a high number of antibodies,” he added, without specifying which of his two daughters took part in trials.
In July, the UK Government accused Russian hackers of targeting its own research into immunisation. The Kremlin rejected the accusations.
Russian health officials said the new vaccine would be offered to medics as early as this month, before being rolled out to the general population on a voluntary basis from October. Kirill Dmitriev, the head of the Russian Direct Investment Fund, said there had been preliminary orders for more than a billion vaccine doses from 20 countries.
The vaccine has been named “Sputnik V”, drawing comparisons to the Cold War space race. Scientists in Russia and abroad highlighted that it had yet to pass “phase three” clinical trials, which typically take months, involving thousands of people.
Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally essential precursors for a vaccine to receive regulatory approval. “This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical,” said Prof Francois Balloux, of University College London’s Genetics Institute. “Any problem with the Russian vaccination campaign would be disastrous through its negative effects on health, and because it would further set back the acceptance of vaccines in the population.”
Dr Michael Head, a senior research fellow in global health at the University of Southampton, said: “It is vital that a vaccine roll-out has the confidence of the public, and that there is good communication of the level of effectiveness and any likely side effects. At this point, there is no data on the Russian-led vaccine for the global health community to scrutinise.” The World Health Organisation said approval would require a rigorous safety data review.
This week, a Russian association of multinational pharmaceutical companies called for more tests on the drug.
More than 100 possible vaccines are being developed worldwide. At least four are in final “phase three” human trials, according to WHO data.
Russia has registered almost 900,000 infections, and more than 15,000 deaths, a lower proportion than other badly hit nations. Officials denied they were under-reporting figures.
Germany also raised doubts over the vaccine, stressing that drug approval is granted in the European Union only after full clinical trials. A health ministry spokesman said. “There is no known data on the quality, efficacy and safety of the Russian vaccine.”
The vaccine uses the common coldcausing adenovirus modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognise if a real Covid-19 infection comes along. That is a similar technology to vaccines being developed by China’s Cansino Biologics and Britain’s Oxford University and Astrazeneca. However, unlike those, Russian scientists have not published any scientific information about how the vaccine has performed in animal tests or in early-stage human studies. The Russian health ministry said the vaccine is expected to provide immunity for up to two years.
The news prompted dissent in some Russian scientific circles. “Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s Association of Clinical Trials Organisations, in urging government officials to postpone approving the vaccine without completed advanced trials.