Russia’s coronavirus vaccine hasn’t been fully tested. Doling it out risks side effects and false protection



A scientist holding a coronavirus vaccine at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia.
Alexander Zemlianichenko Jr/Russian Direct Investment Fund/AP/AAP

Kylie Quinn, RMIT University and Holly Seale, UNSW

On Tuesday, Vladimir Putin announced Russia was the first country to register a vaccine offering “sustainable immunity” against SARS-CoV-2, the virus that causes COVID-19.

Developed by the Gamaleya Research Institute in Moscow, it’s been registered with the Russian Health Ministry and approved for emergency use only.

But there are concerns it will soon be rolled out across the Russian population, far beyond emergency use. This has prompted discussion about the “race” towards a COVID-19 vaccine.

While speed is important, ensuring a vaccine is effective and safe is much more critical. The consequences of doling out a potentially unsafe and ineffective vaccine could be wide-reaching.




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Data about the trials has not been published

The Gamaleya Research Institute announced it registered a SARS-CoV-2 vaccine with the Russian Health Ministry, the local regulatory body that determines which medicines can be used in Russia. This vaccine is called “Sputnik V” and the Institute has indicated it’s approved for emergency use. An emergency use approval generally means a vaccine could be offered to people at very high risk of infection, such as health-care workers, but not the general civilian population.

The Institute had previously registered this vaccine for a Phase I/II trial (to assess safety and immune responses in humans), initially with just 38 people. Senior Russian officials said it induced a strong immune response and no “serious complications” in this trial. This isn’t too surprising, as published data from human clinical trials for other similar vaccines have shown strong immune responses and no serious complications.

However, the data from the trial of Sputnik V has not been published and there is no data that indicates the vaccine would actually protect, as Phase III studies (requiring thousands of volunteers to demonstrate efficacy and detect rare side-effects) haven’t been performed.

The Institute did announce a Phase III trial for Sputnik V will begin on August 12 in Russia and several other countries. However, many scientists (including Russian researchers) expressed concern the vaccine will soon be used in large civilian vaccination campaigns, which wouldn’t usually be the case with an approval for emergency use.

What are the risks

If we go back to the analogy of a “race”, we should stop thinking of vaccine development as the 100-metre sprint. Instead, think of it more like the pentathlon. In the pentathlon, each section the athlete completes contributes to their overall score and cannot be missed. If we try to run this race against COVID-19 without each section, we could end up with a vaccine which has not been properly tested, which could be unsafe and would be unethical. And then we all lose.

The risks of advancing into mass vaccination without proper testing are significant. If a vaccine is released but side-effects emerge, the consequences include both the health impacts and deterioration in trust from our community. If the vaccine does not protect individuals from infection, those who have been vaccinated could falsely believe they are protected.

Our system of methodical series of clinical trials has been designed, oftentimes with hard-won lessons, to avoid oversights and build essential data on safety, immunity and protection with vaccines.

As stated by the US Health and Human Services secretary, Alex Azar:

The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective for the American people and the people of the world.

Development takes time and we need to be realistic with our timelines and expectations.

Testing a vaccine is rigorous

When countries consider introducing a vaccine, the following information is examined:

  • how safe is the vaccine?

  • how well does the vaccine work?

  • how serious is the disease the vaccine would prevent?

  • how many people would get the disease if we did not have the vaccine?

This information is collected during each phase of the clinical trials (Phase I, II and III), with a particular focus on vaccine safety at each step. Developing this package of information can take years, but there have been cases when timelines were condensed.

For example, testing for an Ebola vaccine was condensed down to five years due to a critical need for a vaccine in the midst of ongoing epidemics. Regardless of this urgency, each clinical trial phase was still completed.

Phase III clinical trials are especially critical to assess safety in a large group of people, because certain rare side effects may not be identified in earlier, smaller trials. For example, if a vaccine-related side effect only occurred in one in every 10,000 people, the trial would have to enrol 60,000 volunteers to detect it.

In general, vaccines are more thoroughly tested than any other medicine. We administer vaccines to healthy people, so safety is the key priority, and we administer vaccines to large numbers of people, so rare side-effects must be identified.

What’s in this vaccine?

This type of vaccine is called a viral vector. With viral vectors, we trick our immune system with a bait-and-switch; we take a harmless virus, modify it so it can’t replicate, and include a target from the surface of the SARS-CoV-2 virus. The vaccine looks like a dangerous virus to the immune system, so the immune response is relatively strong and targeted against SARS-CoV-2, but the virus can’t cause disease.

Sputnik V is unusual because it uses two different viral vectors, one after the other, in what we call a “prime boost”. The first is called Ad26, which is similar to a COVID-19 vaccine being developed by Johnson&Johnson, and the second is called Ad5, which is similar to a COVID-19 vaccine being developed by CanSino Biologics. This prime boost should generate a relatively strong immune response, but we don’t know for sure.

Viral vectors are also a relatively new technology. There have been a number of large clinical trials with viral vectors for HIV, Malaria, Tuberculosis and Ebola, but only one for Ebola has ever been approved for use in the general population.




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The Conversation


Kylie Quinn, Vice-Chancellor’s Research Fellow, School of Health and Biomedical Sciences, RMIT University and Holly Seale, Senior Lecturer, UNSW

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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With prizes, food, housing and cash, Putin rigged Russia’s most recent vote



Russian President Vladimir Putin at a polling station to cast his ballot in a nationwide vote on constitutional reforms in Moscow on July 1, 2020.
Alexey Druzhinin/SPUTNIK/AFP via Getty Images)

Regina Smyth, Indiana University

When Russians voted in early July on 200 constitutional amendments, officials rigged the election to create the illusion that President Vladimir Putin remains a popular and powerful leader after 20 years in office.

In reality, he increasingly relies on manipulation and state repression to maintain his presidency. Most Russians know that, and the world is catching up.

At the center of the changes were new rules to allow Putin to evade term limits and serve two additional terms, extending his tenure until 2036. According to official results, Putin’s regime secured an astounding victory, winning 78% support for the constitutional reform, with 64% turnout. The Kremlin hailed the national vote as confirmation of popular trust in Putin.

The vote was purely symbolic. The law governing constitutional change does not require a popular vote. By March 2020, the national legislature, Constitutional Court and Russia’s 85 regional legislatures had voted to enact the proposed amendments.

Yet, the president insisted on a show of popular support and national unity to endorse the legal process.

The Kremlin’s goal was to make Putin’s 2024 reelection appear inevitable. Given the stakes, the outcome was never in doubt – but it did little to resolve uncertainty over Russia’s future.

Declining social support

Why hold a vote if a vote isn’t needed?

As a scholar of Russian electoral competition, I see the constitutional vote as a first step in an effort to prolong Putin’s 20-year tenure as the national leader. The Kremlin’s success defined the legal path to reelection and the strategy for securing an electoral majority in the face of popular opposition.

Protesters in line at the presidential administration in Moscow, waiting to deliver statements that they don’t accept the results of the constitutional amendment vote, July 4, 2020.
Sefa Karacan/Anadolu Agency via Getty Images

Its effect on societal attitudes is less clear. A recent poll by the independent polling organization the Levada Center showed that while 52% of respondents supported Putin’s reelection, 44% opposed. At the same time, 59% want to introduce a 70-year-old age cap for presidential candidates. This change would bar the 68-year-old president from running again.

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The government’s disorganized and weak response to COVID-19 highlighted the inefficient and corrupt system and produced an unprecedented drop in Putin’s public approval ratings.

Growing signs of popular discontent in Russia suggest this polling data underestimates demand for change. Local protest against pollution, trash incineration and state reforms continue to grow across the Federation. Focus group data reveals that ordinary Russians are concerned about state repression and civil rights violations.

In the leadup to the constitutional vote, internet influencers read the public mood and refused payments for their endorsement, fearing a backlash from followers and advertisers.

A new Putin majority

Declining popular support highlights the difficulty of building a new voting coalition. Manufacturing a demonstration of national unity was the first step in reinventing Putin’s links to core supporters in the runup to the next national election cycle.

By 2012, Putin’s first coalition, forged in the economic recovery of the early 2000s, was eroded by chronic economic stagnation punctuated by crisis.

In the mid-2010s, Putin’s new majority was based on aggressive foreign policy actions. That coalition declined, as conflicts in Ukraine and Syria dragged on, and public support for expensive foreign policy adventures decreased.

The constitutional vote marks Putin’s third attempt to reconstruct electoral support rooted in patriotism, conservative values and state paternalism that echoes the Soviet era.

Fixing the vote

The constitutional reform campaign focused on state benefits rather than the Putin presidency.

Putin offered something for everyone in the 200 amendments.

As an antidote to unpopular pension reforms, a new provision guarantees pensioners annual adjustments linked to inflation. Other amendments codified existing policies guaranteeing housing and a minimum wage. New clauses codify Putin’s version of conservative values, with measures that add a reference to God, a prohibition against same-sex marriage and support for patriotic education. Other provisions take aim at corruption, by prohibiting state officials from holding offshore accounts.

A massive PR campaign framed starkly different appeals to different voter groups. For those concerned with international security, ads depicted apocalyptic visions of Russia’s future after a NATO invasion. For younger voters, appeals depicted happy families voting to support a bright future.

State television featured supportive cultural icons and artists, including Patriarch Kirill, who is the head of the Russian Orthodox Church. Putin himself argued that participation was a patriotic duty. No one mentioned the controversial loophole that would allow Putin to run again.

The campaign foretold the outcome: The regime would stop at nothing to secure success. Officials coerced employees of government agencies and large businesses to turn out. Voters were offered prizes, food and chances to win new housing and cash for participating.

Ostensibly in response to COVID-19, the Electoral Commission altered voting procedures to evade observation, developing a flawed online voting system and creating mobile polling stations in parks, airports and outside apartment blocks. There is overwhelming evidence that the Kremlin resorted to falsification to produce the desired outcome.

Most Russians understand that the manufactured outcome does not accurately reflect attitudes about Putin’s reelection.

Limits of disinformation

There is growing evidence that the public is no longer persuaded by disinformation and political theater such as the rigged constitutional vote. Trust in state media, the president and the government are declining precipitously.

Members of a local electoral commission empty a ballot box at a polling station, July 1, 2020.
Alexander Nemenov/AFP via Getty Images

The realities of sustained economic stagnation and the Kremlin’s anemic response to COVID-19 stand in sharp contrast to its all-out approach to the symbolic national vote. It can rig a vote, but it can’t control a virus.

The Kremlin’s pandemic response raises doubts about its ability to fulfill new constitutional mandates. Widely publicized efforts to reform the Soviet-era health care system still left hospitals unprepared to manage the pandemic. The state proved incapable of delivering bonuses to first responders and medical workers. The Kremlin refused to use its substantial emergency fund to support entrepreneurs, families with children and the unemployed.

Given these realities, upcoming elections will test the illusion of a new pro-Putin majority defined by this rigged vote. And if the voters abandon Putin, the new Constitution provides a final path to remain in office: the unelected chairmanship of the powerful new State Council.The Conversation

Regina Smyth, Professor, Indiana University

This article is republished from The Conversation under a Creative Commons license. Read the original article.