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.

Tested positive for COVID-19? Here’s what happens next – and why day 5 is crucial


Julian Elliott, Monash University

With cases of COVID-19 on the rise, many Australians are asking: what happens if I test positive? With no known cure and no vaccine, what are my treatment options?

Finding trusted answers amid the widespread coverage of questionable claims and dubious data on unproven treatments is not easy. The good news is there are clear guidelines and growing evidence on treatments that can have a dramatic effect on COVID-19.

Here’s a snapshot of how this knowledge and guidance is likely to apply to you, if you have mild, moderate or severe COVID-19.




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Testing positive and isolating at home

If you test positive, you must self-isolate at home. Your local public health service will contact you with advice and information about how long you’ll need to do so.

If you are like most people with COVID-19, you won’t need to go to a clinic or hospital, and can safely self-manage the illness at home. Even so, it’s important to connect with an appropriate health-care service (either by contacting a dedicated COVID-19 service or by calling your GP) for an initial assessment and continuing contact throughout your illness.

Initially, you may experience flu-like symptoms such as cough, sore throat, fever, aches, pains and headache. You might temporarily lose your sense of smell and taste; less common symptoms include nausea, vomiting and diarrhoea. Whatever your symptoms, you’ll need plenty of rest, fluids and paracetamol for aches, pains or fever.

Take particular note of how you’re feeling from day five onwards, as this is the time some people begin to deteriorate significantly. Around 20% of people fall into this category, with older people and those with pre-existing health conditions more likely to require hospitalisation. Watch out for intense fatigue, difficulty breathing or an overall deterioration in how you’re feeling.

If your symptoms worsen, you’ll need to contact your care provider, or if your symptoms are very serious (such as difficulty breathing), call 000 and ask for an ambulance, and don’t forget to tell them you have COVID-19.

What if things get worse still?

If you are taken to hospital, doctors will measure your oxygen levels and perform a chest X-ray and blood tests to determine whether you have pneumonia (infection in the lungs, which is a sign of moderate or severe COVID-19). If pneumonia, low oxygen levels or other signs of severe infection are detected, you’ll need to stay in hospital and will probably be given oxygen.

If this is the case, you’ll also be given a strong anti-inflammatory medicine called dexamethasone. This is a widely used, low-cost drug that was recently found to reduce the risk of dying from COVID-19 (by 15% for people on oxygen and by about a third for people on a ventilator). However, for people who are not on oxygen, dexamethasone may increase the risk of death — probably because inflammation is not such a big factor at that stage of disease — and the side-effects of dexamethasone would outweigh any potential benefit to those patients.




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For moderate or severe cases, doctors may also consider a newer antiviral medicine called remdesivir. Originally developed to treat Ebola, this drug has recently been shown to reduce the time to recover from more severe forms of COVID-19 — but not to reduce the risk of dying from the disease.




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If you become even more unwell, these treatments will continue but you may need more support for breathing, such as high-flow oxygen or a ventilator, and will likely be cared for in an intensive care unit.

Recovery

Your recovery depends on many factors, including your previous health and fitness, and how sick you became with COVID-19. The recovery phase is not yet fully understood, but we do know some people suffer prolonged symptoms, including fatigue, breathlessness, and joint and chest pains.




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As scientists continue to grapple with the complexities of understanding and treating this virus, we will have more questions than answers for some time yet.

Fortunately, Australia moved quickly at the start of the crisis to establish a National COVID-19 Clinical Evidence Taskforce. A collaboration of 29 peak national health organisations, the taskforce works around the clock to rapidly identify, evaluate and summarise global COVID-19 research findings. Each week, guideline panels with more than 200 experts use this evidence to review and update national “living guidelines” to inform consistent, high-quality patient care around the country.

This pace of updating rigorous, trustworthy guidelines weekly is a world first. Whatever the global headlines or social media outrage of the day, Australian health workers will continue to have a single, accessible source of consistent, evidence-based guidance in a time of great uncertainty.The Conversation

Julian Elliott, Executive Director, National COVID-19 Clinical Evidence Taskforce, and Associate Professor, School of Public Health and Preventive Medicine, Monash University

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

Vietnam stepping up religious rights abuses, experts say


Government-perpetrated violence against a Catholic village in Vietnam has highlighted a series of human rights abuses in the communist nation, and three U.S. congressmen are calling on the United Nations to intervene, reports Baptist Press.

"A few months ago during a religious funeral procession, Vietnamese authorities and riot police disrupted that sad and solemn occasion, shooting tear gas and rubber bullets into the crowd, beating mourners with batons and electric rods," Rep. Chris Smith, R.-N.J., said at a hearing of the Tom Lantos Human Rights Commission in August.

"More than 100 were injured, dozens were arrested and several remain in custody and have reportedly been severely beaten and tortured. At least two innocent people have been murdered by the Vietnamese police," Smith said.

The Con Dau tragedy, Smith said, "is unfortunately not an isolated incident." Property disputes between the government and the Catholic church continue to lead to harassment, property destruction and violence, Smith said, referring to a report by the U.S. Commission on International Religious Freedom.

"In recent years, the Vietnamese government has stepped up its persecution of Catholic believers, bulldozing churches, dismantling crucifixes and wreaking havoc on peaceful prayer vigils," Smith said.

Persecution is not limited to Catholics, though, as Smith had a list of nearly 300 Montagnard political and religious prisoners. In January, the Vietnamese government sentenced two Montagnard Christians to 9 and 12 years imprisonment for organizing a house church, and others have been arrested in connection with house churches, Smith said.

"The arrests were accompanied by beatings and torture by electroshock devices," the congressman said. "We must not forget the sufferings of Khmer Krom Buddhists, Cao Dai, Hoa Hao, the Unified Buddhist Church of Vietnam and others. The said reality is that the Vietnamese government persecutes any religious group that does not submit to government control."

The violence in the 80-year-old Catholic village of Con Dau in central Vietnam reportedly stemmed from a government directive for residents to abandon the village to make way for the construction of a resort.

International Christian Concern, a Washington-based watchdog group, reported that when Con Dau residents refused to leave, water irrigation was shut off to their rice fields, stopping the main source of income and food.

In May, police attacked the funeral procession, beating more than 60 people, including a pregnant woman who was struck in the stomach until she had a miscarriage, ICC said.

One of the funeral procession leaders later was confronted by police in his home, where they beat him for about four hours and then released him. He died the next day, ICC said. Eight people remain in police custody and are awaiting trial.

"The people of Con Dau are living in desperate fear and confusion," Thang Nguyen, executive director of an organization representing Con Dau victims, told ICC. "Hundreds of residents have been fined, and many have escaped to Thailand."

Smith, along with Rep. Joseph Cao, R.-La., and Frank Wolf, R.-Va., introduced a House resolution in July calling for the United Nations to appoint a special investigator to probe "ongoing and serious human rights violations in Vietnam." In August, the Lantos Commission met in emergency session to address the "brutal murders and systematic treatment of Catholics in Con Dau."

"The Vietnamese government justifies this violence, torture and murder because the villagers of Con Dau had previously been ordered, some through coercion, to leave their village, property, church, century-old cemetery, their religious heritage, and to forgo equitable compensation in order to make way for a new ‘green’ resort," Smith said at the hearing. "Nothing, however, not even governmental orders, grant license for government-sanctioned murder and other human rights abuses."

The U.S. Department of State declined to testify before the Lantos Commission, and the U.S. ambassador to Vietnam characterized the Con Dau incident as a land dispute and refused to get involved.

Logan Maurer, a spokesman for International Christian Concern, told Baptist Press he has publicized about 10 different incidents of persecution in Vietnam during the past few months.

"In some cases, especially in Southeast Asia, religious persecution becomes a gray area. We also work extensively in Burma, where often there are mixed motives for why a particular village is attacked," Maurer said. "Is it because they’re Christian? Well, partially. Is it because they’re an ethnic minority? Partially.

"So I think the same thing happens in Vietnam where you have a whole village that’s Catholic. One hundred percent of it was Catholic," he said of Con Dau.

Maurer explained that local government officials in Vietnam generally align Christianity with the western world and democracy, which is still seen as an enemy in Vietnam on a local level.

"As far as the official government Vietnamese position, that’s different, but local government officials do not take kindly to Christians and never have. We have documented many cases of government officials saying Christianity is the enemy. So here it’s mixed motives as best we can figure out," Maurer said.

"They wanted to build a resort there, and they could have picked a different village but they chose the one on purpose that was Catholic because it represents multiple minorities — minority religion, minority also in terms of people that can’t fight back. If they go seek government help, the government is not going to help them."

A Christian volunteer who has visited Vietnam five times in the past decade told Baptist Press the Con Dau incident illustrates the way the Vietnamese government responds to any kind of dissent.

"In our country, and in modern democracies, there are methods for resolving disputes with the government, taking them to court, trying to work through the mediation process," the volunteer, who did not want to be identified, said. "In Vietnam there is no such thing. It is the government’s will or there will be violence."

Vietnam’s constitution includes a provision for religious liberty, but the volunteer said that only goes as far as the communal will of the people, which is monopolized by the Communist Party.

"So when the Communist Party says you can’t build a church there or you can’t worship this way, those who say, ‘Well, I have religious freedom,’ are essentially trumped by the constitution that says it’s the will of the people, not individual liberty that’s important," the volunteer said.

The government in Vietnam has made efforts during the past 15 years to open up the country to economic development, and with that has come an influx of some western values and a lot of Christians doing work there, the volunteer said.

"I would first caution Christians to still be careful when they’re there working," he said, adding that government officials closely watch Christians who visit from other countries, and books about Jesus cause trouble.

Secondly, the volunteer warned that all news emerging from Vietnam must be tested for accuracy on both sides because both those who are persecuting and those who are sounding the alarm on persecution have their own political goals.

"That being said, I don’t doubt that this happened," the volunteer said regarding Con Dau.

International Christian Concern urges Americans to contact the Vietnamese Embassy in Washington at 202-861-0737, and the Christian volunteer said people can contact the U.S. Commission on International Religious Freedom to encourage changes in Vietnam.

"They can also directly e-mail the ambassador and the consular general in Ho Chi Minh City and encourage them to push for more reform," he said. "And they can contact companies that are having products made in Vietnam and encourage the business leaders to speak out for change in those countries. You go to JC Penney today in the men’s department and pick up almost anything, it’s made in Vietnam. That’s the kind of pressure they could put on them."

Report from the Christian Telegraph

Hindu radicals threaten persecution; Christians start radio program


Hindu extremists in Nepal have threatened to use 1 million bombs against Christians in the country unless they stop sharing the Gospel and leave, Compass Direct reports.

The Nepal Defense Army’s statement, released shortly after the bombing of Nepal’s largest Roman Catholic church, gave “Nepal’s 1 million Christians a month’s time to stop their activities and leave the country,” reports MNN.

Most recent estimates by Voice of the Martyrs indicate that the number of Christians in the country may be closer to 500,000, or 1.89 percent of the population. These Christians are excited about significant movement toward democracy and more religious freedom in the last few years.

Ty Stakes with HCJB Global visited Nepal a month ago and said the Christians are standing firm.

“They’re very grateful for all that God has done over recent years to bring about a climate where there is a real push forward for freedom, where there is some religious liberty in the country,” he said. “So I don’t think anybody there is going to give up very easily. These are people who have been tried and tested and have learned to keep walking forward. God is doing some really big some stuff in Nepal, and the church is growing. People are really attracted to the Gospel.”

Christians in Nepal are establishing FM radio stations in two different towns — one near Kathmandu, the nation’s capital; and the other in a town in the center of the country. The idea for the stations was born around the year 2006 when the government began allowing private operation of radio stations.

“God had given some of our partners vision to do radio in the country, and they understood in their own hearts how great an impact could be made through it,” Stakes said.

Currently, the stations are test broadcasting for three hours a day. The community is already responding.

“I’m getting reports now from Nepal that folks are responding, that folks are saying ‘Hey, we’re interested in the new station; we want to know more about what you’re doing,'” Stakes related.

Christians will not be able to evangelize overtly on the air, but they will use the stations to plant churches.

“The climate in the area is such that you can’t be extremely bold and direct on the radio. You have to be wise,” Stakes said. “So most of our partners…are really church planters who are using radio as a way to create in the community an identity and to present a mechanism where they can serve the community.”

The stations air Christian music, secular music, and community service programming. The goal is to challenge and impact the community’s perception of Christians, presenting “an identity that shows perhaps that what you’ve heard about Christianity is not true. Maybe these Christians do care about people, and maybe they really do have something relevant to say,” Stakes explained.

Evangelism occurs off the airwaves, when people in churches and in church-planting follow up with those who respond to the radio broadcasts. Stakes asked for prayer as Nepalese Christians fine-tune the new radio stations.

“You can pray…that God would give these folks real wisdom in how to fine-tune their strategy in establishing their identity in the community,” Stakes said. “It’s a real delicate balance that they need to strike, and they need real wisdom from the Lord in order to effectively speak to the community and present their identity so that people will be attracted to the message of the cross.”

Report from the Christian Telegraph

CROCODILE ATTACK: HUMAN REMAINS FOUND IN CROCODILE


A 4.3m long crocodile has been caught and tested following the disappearance of Arthur Booker in the Endeavour River near Cooktown (Queensland, Australia) two weeks ago. Male human remains have been found within the crocodile and police have been notified of the find. DNA tests are now to be carried out to confirm the identity of the human remains, though it is more than likely to be those of Arthur Booker.