by Miceál O’Hurley
DUBLIN — The Russian Federation is hailing their breakthrough in developing a Covid-19 vaccine in what the head of Russia’s National Wealth Fund, Kirill Dmitriev, describes as a ‘Sputnik moment’ demonstrating Russia’s achievements as an advanced scientific nation. “Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have got there first,” he added. Russia’s sovereign wealth fund is financing the nation’s Covid-19 vaccine research.
“Our scientists focused not on being the first but on protecting people,” said Dmitriev.
“The vaccine uses human adenovirus vectors that have been made weaker so they do not replicate in the body. Unlike most vaccines in development it relies on two vectors, not one, and patients would receive a second booster shot”. It has been announced that Russia intends to launch widespread vaccinations beginning 10 August 2020 if not earlier.
The Race to Find a Vaccine
As AstraZeneca and the University of Oxford, Pfizer and BioNTech, CureVac, Moderna and CanSino are all now in human testing trials attempting to speedily develop safe and effective vaccines to combat Covid-19, Russia’s release of their vaccine into the general population would place them well ahead of the others who are generally in the early days of Stage III trials. Russia has claimed, in part, their advances have been made possible by basing their vaccine on a similar drug which was previously approved for general use. Critics counter that Russia’s achievement has been made possible by essentially bypassing universally accepted safeguards built into clinical trials of new pharmaceuticals.
Amid the proliferation of worldwide conspiracy theories and fears about the speed with which vaccines are being developed to combat the pandemic a spotlight has been focused on safety and human trials. Critics of the Russian vaccine programme raise the spectre of circumventing careful clinical trials across sufficiently large populations over an acceptable period of time to establish not only efficacy but safety. Still, vaccine developers such as AstraZeneca and the University of Oxford, Pfizer and BioNTech, Moderna, CanSino and CureVac have all been engaged in a virtual tightrope exercise trying to both please investors and simultaneously caution the public against overzealous expectations about vaccine delivery dates.
Many of the more promising vaccines have already reached Phase III in their clinical trials where larger populations undergo research and testing using the proposed vaccine and placebo control groups to adjudge efficacy and human safety. The public face of American efforts to combat Covid-19, Dr. Anthony Fauci, Director of the US National Institute of Allergy and Infectious Diseases, has indicated as recently as last week that absent some unusual breakthrough he did not expect any vaccine approvals, let alone large-scale production of the drugs now in Phase III trials, before at least February 2021. Reportedly, Russia’s vaccine has yet to complete Phase II.
According to the Russia Federation Defense Ministry numerous military personnel served as volunteers in human trials. In recorded comments provided exclusively to CNN, Alexander Ginsburg, the Director of the Russian vaccination programme, announced he had already self-administered the vaccine without any ill effects. According to the Russian Health Ministry all frontline medical staff will be first in the order of vaccination followed by public use after approval. Russian scientists developing the vaccine and administering the clinical trials have indicated they are at present compiling data to make all research and clinical trial outcomes available for publication and peer review by mid-August.
Russia’s Breakneck Progress on Vaccine Development
Phase II trials are expected to conclude by 3 August at which time they will engage in Phase III testing in parallel with the vaccination release with medical personnel before public vaccinations commence. The Russian developers insist they are confident their vaccine development and roll-out is not only safe, but based on modified version of a drug already approved and in use, and their efforts are otherwise reflective of the extreme urgency of the pandemic. Russia has to date reported in excess of 800,000 Covid-19 cases.
Like its Russian competitor, pharmaceutical maker Moderna is also betting on their novel coronavirus vaccine being achieved on the backbone of a related research drug to treat Middle East Respiratory Syndrome (MERS). Moderna is the United States’ chosen partner in Covid-19 vaccine development. Despite the expediency of basing any new vaccines on previously proven drugs, both the Food and Drug Administration (FDA) in the United States as well as regulators in the European Medicines Agency in the European Union have been unwavering in their insistence on requiring full safety and efficacy testing for all new Covid-19 vaccines.
Hacking and Claims of Intellectual Property Theft
In July 2020, the United States, Canada and the United Kingdom claimed that computers holding intellectual property and research necessary to develop a safe and effective vaccine had been hacked by Russian intelligence assets. Kremlin sources have vehemently disputed such claims instead pointing to their licensing partnership with AstraZeneca as proof that Russia engages in commercial contracts for drug development like any other nation and therefore have no need to engage in such activity.
Russian Federation Ambassador to Ireland, His Excellency Yuriy Filatov, was adamant about Russia’s advances being a credit solely to Russian scientific expertise, “It is true that recently US, Canada and UK have put forward a spate of stories about ‘Russian spies stealing vaccine research’ in the West. Nothing new in that, but for a novel change in the British foreign secretary’s language in trying to substantiate these claims – this time it is ‘almost certain’ instead of ‘highly likely’. What is certain, however, is that Russia has nothing to do with this story. Moreover, it would be really difficult to explain such insinuations in light of remarkable advances in the development of an anti-Covid-19 vaccine in Russia”.
“It has been a matter of public record for some time now that the Moscow Institute of Virusology and Microbiology has already successfully concluded a set of human trials of the vaccine and is aiming at the early production of the much-needed anti-Covid-19 instrument” added Ambassador Filatov. “There are at least five other Russian research centres which are at more or less the same stage of the vaccine development.”
Russia Vaccine Sharing
Given Russia’s unique development activity for their Covid-19 vaccine it remains highly uncertain that even should it prove successful it could be shared by Russia outside a limited number of nations. With shortened clinical trials and Russia’s decision to develop the vaccination outside of either standard European Medicines Agency or FDA protocols and guidelines, any success Russia may achieve with their vaccine may not help them bring the drug to the worldwide market in a timely manner.
Notwithstanding criticism from the West, Ambassador Filatov re-affirmed Russia’s commitment to developing a safe and effective vaccine, “Russia has consistently proposed to the international community to join the efforts in fighting the disease within the framework of wide international co-operation. We do not view the anti-COVID vaccine research in terms of a “race” between different nations to be first on the market. The effort is aimed to confront the disease early, under strict scientific and sanitary regulations, making sure that the new vaccine is safe, effective and available for as wide population as possible”.
As with Sputnik in 1957, all eyes are on Russia while efforts continue to be focused on those still in the race, not to reach outer space this time, but to develop a safe and effective Covid-19 vaccine.