A group of international doctors have written to the British medical magazine The Lancet raising questions about the veracity of the data presented in a recent paper that showed the Russian Sputnik V vaccine was “100% effective” in Phase II trials.
Russia has rushed through the registration of the vaccine and intends to give it to those in high-risk jobs, such as health workers, in October. A general roll-out of the vaccine is planned for early in the New Year after Phase III trials are completed.
On August 11, Russia became the first country worldwide to register a vaccine against the coronavirus (COVID-19). It was named Sputnik V and prepared by the Gamaleya National Research Center. It passed Russian clinical trials in June-July. It is based on a known platform previously used to fight Ebola. On August 15, the Healthcare Ministry announced the production launch of the preparation. On September 8, the first batch of the vaccine was released for civilian circulation.
Russia has drawn heavy criticism for rushing the test and the fast-track registration of the vaccine that has as yet not been fully tested. However, now there is some evidence to suggest the data from the Phase II trials may have been falsified.
The researchers flagged concerns over seemingly identical levels of antibodies in some of the small number of study participants who were inoculated with the experimental vaccine. They also identified other problems with the statistical distribution patterns of the results in the study. The numbers in a study like this should be random but mathematical technics can be used to test the randomness of the distribution of the numbers and identify patterns that usually mean the results have been tampered with.
The scientists wrote an open letter headed up by Temple University Professor Enrico Bucci. It was signed by more than a dozen other scientists.
The Lancet published results of the early-stage trial in the first week of December, offering a first look at the Russian study to be vetted by outside experts.
“We have shared the letter directly with the authors and encouraged them to engage in the scientific discussion,” The Lancet said in a statement as cited by Bloomberg.
The Gamaleya Research Institute of Epidemiology and Microbiology and the Russian Direct Investment Fund, which are developing the vaccine, said the data was not manipulated.
The vaccine development is being funded by the Russian Direct Investment Fund (RDIF), which hopes to capture up to a third of the estimated $75bn market for a working vaccine. RDIF intends to sell 32mn doses of Sputnik V to Mexico, with deliveries starting in November, the sovereign wealth fund said in a statement on September 8. It has also promised doses to Belarus, Uzbekistan and Kazakhstan. Turkey, meanwhile, is considering a request to conduct Phase III trials.
More than 20 countries have requested over 1bn doses of Russia's vaccine despite safety concerns raised by health experts.
The important large-scale Phase 3 testing that will study 40,000 volunteers over 180 days began on September 8, the Health Ministry said in a statement. A total of 10,000 of the trialists will take placebos. The first results from the Phase III study may be published in October or November, according to the RDIF.
Sputnik V is one of three vaccines that have made it through Phase II testing, while US competitor AstraZeneca has announced it has halted trials of its vaccine after one of the test subjects became ill.
“Sputnik is a human vaccine, while AstroZeneca’s is a monkey vaccine,” Kremlin spokesman Dmitry Peskov said on September 8 on a conference call. “Our scientists believe that the human vaccine is much more reliable in this regard.”
Even though the Phase III trials have only begun, the RDIF has already started manufacturing the vaccine in bulk, with the first deliveries due to be dispatched in November and December, the Russian Healthcare Minister Mikhail Murashko said on September 7 during a working visit to Arkhangelsk.
The minister noted that now it is also important to begin inoculation against the flu and that the Arkhangelsk Region has already received batches of this vaccine.
The ministry's announcement follows a flurry of reports saying that several high-level Russian government officials have received the Sputnik V vaccine and have made public appearances in good health.
The state-run Gamaleya epidemiology and microbiology research centre that developed Sputnik V has estimated that it would need to produce 80mn doses to achieve mass immunity in Russia.
Russia has officially reported more than 1mn coronavirus infections and almost 18,000 deaths since recording its first case in March.
If mass vaccination goes to plan, Russia will see an end to COVID-19 by next summer, Alexander Gintsburg, the director of Moscow's Gamaleya Centre, said on September 8.
Gintsburg believes the world will only be able to defeat the pandemic after mass vaccination, which he thinks can happen within a year. Until then, he predicts that society will be engaged in "constant battles" with the virus.
"We'll only be able to say that the pandemic has receded when we've produced the required amount of vaccine and vaccinated the entire population of our country and part of the globe," he said as cited by RT.