Russia's Sputnik V has won the global race to be the first Covid-19 vaccine rolled out to the public. However, its official release has bypassed phase-3 trials – which have not even started. Photo: AFP

ST PETERSBURG – Russia is first past the post in the race to release a Covid-19 vaccine to the public.

The country’s response to the virus is ready to go, Moscow authorities announced on Tuesday as they rolled out the first vaccine batch, which is being offered to individuals in high-risk professions – doctors and teachers.

However, widespread concerns over the vaccine’s safety have been raised as it has received official approval from the Health Ministry without third-phase clinical trials even having begun. Phase 1 and 2 trials included a small total of just 76 persons – all healthy test subjects aged 18-60. 

Russia’s rush to release its vaccine comes amid various global developments. 

China says it will be ready to produce massive quantities of vaccine by the end of the year and US President Donald Trump says a US vaccine may be good to go by November. Meanwhile, trials of one of the most promising vaccines, developed by AstraZeneca and Oxford University, have been halted because a test subject developed a mysterious illness. 

‘Sputnik V’ lifts off

The Russian vaccine bears a proud name: It is branded Sputnik V after the Soviet satellite that became the first man-made vehicle to enter space in 1957.

The vaccine has significant national credibility invested: It was developed by the prestigious Gamaleya National Center of Epidemiology and Microbiology with funding from the state-owned Russian Direct Investment Fund. 

A first report on its efficacy was published last week in the prestigious scientific journal The Lancet. 

According to the article, phase-1 and phase-2 trials were completed successfully, with participants developing antibodies and showing only mild side effects. But the article also pointed out that larger and longer trials are needed to future-proof its long-term efficacy and safety.

Still, Russia’s top voice has made clear Sputnik V is ready for launch.

“I know [the vaccine] works quite effectively, helps to develop strong immunity, and has gone through all the necessary tests,” Russian President Vladimir Putin said in August. Putin also announced that his own daughter was among the individuals upon whom the vaccine was tested. According to Bloomberg, other members of the Russian elite were among volunteers taking part in the early trials. 

Sputnik V is based on two types of adenovirus (a virus that usually causes the common cold) which act as vectors carrying the coronavirus gene into the cells and triggering an immune response. 

The first two test phases were conducted in June and July, each one of them involving 38 volunteers aged between 18 and 60. Each participant was given a first dose of vaccine and then a booster shot 21 days later. 

Critics note that the volunteers who participated in the first two trials were largely healthy individuals aged 18-60. In other words, they did not reflect the categories of people most at risk – the very old, and those with pre-existing medical conditions.

Phase-3 trials – due to start this month in a number of countries including the United Arab Emirates, India, Brazil, Saudi Arabia and the Philippines – will involve a far heftier sample population of 40,000 people 

In the meantime, persons in high-risk categories, notably doctors and teachers, started receiving vaccinations as of Tuesday.

Concerns and criticisms vs the Kremlin 

But while Moscow may be investing its national prestige in the early rollout of the Russian vaccine, the speed of that process has raised widespread concerns regarding its safety and efficacy. 

Sputnik V – together with two vaccines developed by CanSino and Sinovac in China – have received official approvals without passing phase-3 tests. That means mass distribution will start before the third phase of mass testing is completed. According to the deputy director of the Gamaleya Institute, Denis Loginov, Phase-3 trials will take a minimum of six months. 

It’s a risky move, say critics. Vaccines that showing positive results in the early trial phases have often proved flawed when tested in phase 3, which involves the largest numbers of participants. 

The early rollout of Sputink V has been met with some skepticism among the public. 

According to a recent poll, 52% of Russian doctors are unwilling to take the vaccine, mostly due to the “lack of data” confirming the vaccine’s efficacy. 

Last month, the Russian teachers’ Union Uchitel launched an online petition opposing mandatory vaccination until all trials are completed. While Putin previously said the vaccination should happen “exclusively on a voluntary basis,” there are concerns teachers might be subjected to pressure to get the vaccine. 

Predictably, there has been criticism from across the Atlantic. 

“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” Washington’s top virus expert Anthony Fauci told National Geographic. “I seriously doubt that they’ve done that.”

Equally predictably, Russian authorities have returned fire upon the naysayers. 

“It seems our foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express opinions that… are absolutely groundless,” said Russia’s Health Minister Mikhail Murashko.

A dedicated website has been created to inform people of Sputnik V and “combat the misinformation campaign launched against it in international media.” 

Pro-Kremlin media have also been deployed to defend the achievement of Russian scientists in a cold war fashion. “West, get ready!” read the headline of pro-Kremlin media outlet Tsargrad.

“Are you afraid to admit you lost? US clumsily justified itself for renouncing the COVID-19 vaccine,” reads another headline, referring to a White House statement according to which the US won’t take part in WHO-led efforts to develop a vaccine. 

Experts offer their takes

Experts are divided. 

According to Ilya Yasny, head of scientific due diligence at venture firm Inbio Ventures, the early approval of the vaccine is explained by Russia’s customary approach to regulatory procedures. “The approval procedure of vaccines in Russia is traditionally not as rigorous as in the West,” he pointed out.

The Kremlin’s early approval can also be seen as a move justified by the urgent nature of the emergency that Covid-19 has precipitated – which Yasny defines as “understandable.” Even so, according to him “the risk outweighs the benefits.” 

“People receiving the vaccine might start disregarding safety norms like wearing masks,” he pointed out. “That is dangerous in that the vaccine hasn’t proved its 100% efficacy.” 

Polina Stepensky, chair of the Bone Marrow Transplantation and Cancer Immunotherapy Department at Jerusalem’s Hadassah hospital, praised the platform used by Russian scientists to develop the vaccine, which “proved its efficacy in the first two phases of testing.”  

Stepensky dismissed concerns around the possible flaws of “Sputnik V” as speculation. 

“There is no reason to speculate on the efficacy of the vaccine until the third phase of testing is completed,” she told Asia Times

Winning the race

A total of 37 vaccines are currently being tested around the world; Sputnik V is among nine which have reached phase-3 trials.

While countries including Germany and South Korea, citing safety concerns, have stated that it is unlikely that there will be a rollout of vaccination programs before the middle of 2021, elsewhere the race is on. And Russia is not alone in fast-tracking approvals 

In China, where the pandemic originated, three separate vaccines have been developed, and will reportedly be ready for mass issuance by the end of the year. Two have already been officially approved.

Last week, US President Donald Trump said that a US vaccine could be ready before the November 3 presidential election, though his top official for infectious diseases, Dr Anthony Fauci, has been more cautious in his predictions.

Conversely, arguably the most highly awaited vaccine – joint-developed by AstraZeneca and Oxford University – hit a bump in phase-3 trials on Tuesday. After one subject suffered a surprise ailment, the vaccine’s trials were suspended, though they could, feasibly, restart in days if an investigation proves that the subject’s illness is unrelated to the vaccine.

According to estimates by the Gamaleya Institute, 80 million doses will be needed in order to provide the Russian population with mass immunity, a goal that can be achieved by the summer of 2021 if the nation mobilizes “all the possible capacities.”  

However, according to Yasny, such a goal will be hard to achieve. 

“Russia doesn’t have any experience in producing this type of vaccine in such large volumes,” he told Asia Times. He also added that preserving the efficacy of the vaccine when produced in such volumes poses serious challenges.