Who pays compensation if a COVID-19 vaccine has rare side-effects? Here’s the little we know about Australia’s new deal



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Nicholas Wood, University of Sydney

In last week’s federal budget the Australian government announced it had given the suppliers of two COVID-19 vaccines indemnity against liability for rare side-effects.

Although details are unclear, it appears the government would foot the bill for compensation if a member of the public wins legal action against the drug company.

This is in contrast to 25 other countries with no-fault compensation schemes for rare vaccine side-effects.

Here’s the little we know about Australia’s latest indemnity deal and what we could be doing better.

What do we know about Australia’s new deal?

The deal relates to two vaccines the government had previously announced it would supply, should clinical trials prove successful.

These are the University of Oxford vaccine, from AstraZeneca, and the University of Queensland vaccine, from Seqirus (part of CSL).

However, it is not entirely clear what this indemnity deal means in practice. The budget papers say the government will cover:

certain liabilities that could result from the use of the vaccine.

The government considers further details “commercial in confidence”.

For instance, we don’t know how serious or disabling a side-effect would have to be to qualify or whether there is any cap on the amount of compensation.

We also don’t know what would happen if there were errors involved, or contaminants introduced, while manufacturing the vaccine. These would still be the company’s liability, but it may be hard to determine where boundaries lie.




Read more:
Putting our money on two COVID vaccines is better than one: why Australia’s latest vaccine deal makes sense


How unusual is this?

This deal is not entirely new or unexpected. The government has provided some indemnity to pharmaceutical companies that make vaccines against smallpox and influenza.

The governments of many other countries have also agreed to indemnify COVID-19 vaccine manufacturers, including governments in the UK, US and the European Union.

The manufacturers believe that as the use of their vaccine is for the benefit of society, they should not be held financially accountable for any consequences from a vaccine reaction.




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Big pharma’s safety pledge isn’t enough to build public confidence in COVID-19 vaccine – here’s what will


So what does this mean for the public?

If a person in Australia believes they have been injured by a vaccine, including future COVID-19 vaccines, they will need to pursue compensation through the legal system.

Under the latest agreement, it would appear the government, rather than the drug company, would pay that compensation, should the person win their case.

However this is not ideal. The person still has to engage with the legal system, which is both costly and complex, and there’s no guarantee of success.

Woman consulting professional looking woman in office
Under the latest indemnity deal, it seems that people would still need to go through the legal system, with no guarantee of success.
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Compensation may not even be possible via our legal system. That’s because in most cases, it will be difficult to show in court a serious side-effect was due to a fault in the vaccine composition or negligence in the way it was administered.

So in Australia, people with a vaccine injury, either COVID-19 or other vaccine, will likely bear the costs of their injury by themselves, and seek treatment by our publicly-funded or private health systems.

The National Disability Insurance Scheme helps fund therapies for people with a permanent and significant disability but does not cover temporary vaccine-related injuries.

Participants in COVID-19 vaccine clinical trials can be compensated for temporary and permanent vaccine injuries.




Read more:
The budget assumes a COVID-19 vaccine becomes available next year. Is this feasible?


What’s happening overseas?

In the US, people with a rare but serious reaction to a COVID-19 vaccine will be able to access a special compensation scheme. This is designed to provide compensation for the use of COVID-19 pandemic medications and vaccines.

However, applicants only have one year from the date they had the vaccine or medicine to request benefits.

The US already has a vaccine compensation scheme for vaccines other than COVID-19. This is an example of a no-fault compensation scheme. These compensate for specific vaccine reactions, without having to go to court to prove the vaccine manufacturer is liable.

Australia, in contrast to 25 countries including the US, UK and New Zealand, does not have a no-fault vaccine compensation scheme, and does not have the equivalent of the US COVID-19 vaccine compensation scheme.

How would a no-fault system work?

There are numerous benefits to a no-fault vaccine compensation system. These include simplified access to compensation, and avoiding a lengthy, costly and complex encounter with the legal system, with no guarantee of success.

Most are government funded. The US government funds it by a flat rate of US$0.75 for each disease prevented for each vaccine dose.

Finland and Sweden fund their programs via insurance payments from pharmaceutical companies marketing their products there.

The New Zealand scheme includes compensation for vaccine-related injuries, as well as for accidents and treatment injuries. This is funded through a combination of general taxation, and levies collected from employee earnings, businesses, vehicle licensing and fuel.

However, compensation awarded via such no-fault schemes is usually lower than you would receive after a successful liability lawsuit.




Read more:
We’re all at risk from scary medicine side effects, but we have to weigh the risks with the benefits


Where to next?

To encourage people to receive COVID-19 vaccines for the benefit of the entire community, we need compensation schemes to be in place if there is a rare but serious side-effect.

Should options to increase vaccine uptake include mandates or penalties — such as employment or travel restrictions if not vaccinated — this would make a no-fault vaccine compensation scheme even more essential.

Although it is important manufacturers receive indemnity for “certain liabilities”, we still need to look after our community. That means a compensation system the public can easily access and which provides appropriate support.The Conversation

Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of Sydney

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

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.

Moroccan Convert Serving 15 Years for His Faith


Christian’s sentence for ‘proselytism,’ burning poles called excessive.

ISTANBUL, September 17 (CDN) — Nearly five years into the prison sentence of the only Christian in Morocco serving time for his faith, Moroccan Christians and advocates question the harsh measures of the Muslim state toward a man who dared speak openly about Jesus.

By the end of December Jamaa Ait Bakrim, 46, will have been in prison for five years at Morocco’s largest prison, Prison Centrale, in Kenitra. An outspoken Christian convert, Bakrim was sentenced to 15 years prison for “proselytizing” and destroying “the goods of others” in 2005 after burning two defunct utility poles located in front of his private business in a small town in south Morocco.

Advocates and Moroccan Christians said, however, that the severity of his sentence in relation to his misdemeanor shows that authorities were determined to put him behind bars because he persistently spoke about his faith.

“He became a Christian and didn’t keep it to himself,” said a Moroccan Christian and host for Al Hayat Television who goes only by his first name, Rachid, for security reasons. “He shared it with people around him. In Morocco, and this happened to me personally, if you become a Christian you may be persecuted by your family. If you keep it to yourself, no one will bother you. If you share it with anyone else and start speaking about it, that’s another story.”

Rachid fled Morocco in 2005 due to mounting pressure on him and his family. He is a wanted man in his country, but he said it is time for people to start speaking up on behalf of Bakrim, whom he said has “zeal” for his faith and speaks openly about it even in prison.

“Our Moroccan brothers and sisters suffer, and we just assume things will be OK and will somehow change later by themselves,” said Rachid. “They will never change if we don’t bring it to international attention.”

Authorities in Agadir tried Bakrim for “destruction of the goods of others,” which is punishable with up to 20 years in prison, and for proselytism under Article 220, which is punishable with six months to three years in prison.

“Jamaa is a manifestation of a very inconvenient truth for Moroccan authorities: there are Moroccan converts to Christianity,” said Logan Maurer, a regional director at U.S.-based advocacy group International Christian Concern (ICC). “The government wants to ignore this, suppress it, and when – as in Jamaa’s case – the problem won’t go away, they do whatever they can to silence it.”

Proselytism in Morocco is generally defined as using means of seduction or exploiting weakness to undermine the faith of Muslims or to convert them to another religion.

Recently Morocco has used the law to punish any proclamation of non-Muslim faith, contradicting its pledge to allow freedom to manifest one’s faith under the International Covenant on Civil and Political Rights, to which it is a signatory. Article 18 of the covenant affirms the right to manifest one’s faith in worship, observance, practice or teaching.

The covenant also states, however, that “freedom to manifest one’s religion or beliefs may be subject only to such limitations as are prescribed by law and are necessary to protect public safety, order, health, or morals or the fundamental rights and freedoms of others.”

There are an estimated 1,000 Moroccan Christian converts in the country. They are not recognized by the government. About 99 percent of Morocco’s population of more than 33 million is Muslim.

Between March and June authorities expelled 128 foreign Christians in an effort to purge the country of any foreign Christian influences. In April nearly 7,000 Muslim religious leaders backed the deportations by signing a document describing the work of Christians within Morocco as “moral rape” and “religious terrorism.” The statement from the religious leaders came amid a nationwide mudslinging campaign geared to vilify Christians in Morocco for “proselytism” – widely perceived as bribing people to change their faith.

In the same time period, Moroccan authorities applied pressure on Moroccan converts to Christianity through interrogations, searches and arrests. Christians on the ground said that, although these have not continued, there is still a general sense that the government is increasingly intolerant of Christian activities.  

“They are feeling very bad,” said Rachid. “I spoke to several of them, and they say things are getting worse…They don’t feel safe. They are under a lot of disappointment, and [they are] depressed because the government is putting all kinds of pressure on them.”

 

From Europe to Prison

Bakrim, a Berber from southern Morocco, studied political science and law in Rabat. After completing his studies he traveled to Europe, where he became a Christian. Realizing that it would be difficult to live out his new-found faith in Morocco, in 1993 he applied for political asylum in the Netherlands, but immigration authorities refused him and expelled him when his visa expired.

In 1995 Bakrim was prosecuted for “proselytizing,” and spent seven months in jail in the city of Goulemine. In April 1996 he was transferred to a mental hospital in Inezgane, where authorities ordered he undergo medical treatments. He was released in June. The psychiatric treatment caused side-effects in his behavior and made it difficult for him to control his hands and legs for a period of time, sources told Compass.

Two years later authorities put him in jail again for a year because he publicly displayed a cross, according to an article by Moroccan weekly Le Journal Hebdo published in January 2005.

“He has a zeal about his religion,” said Rachid. “He never denied his faith through all these things, and he even preached the gospel in prison and the psychiatric place where they held him … They tried to shut him [up], and they couldn’t.”

In 2001 Bakrim again attracted attention by painting crosses and writing Bible verses in public view at his place of business, which also served as his home, according to the French-language weekly. Between 2001 and 2005 he reportedly wrote to the municipality of Massa, asking officials to remove two wooden utility posts that were no longer in use, as they were blocking his business. When authorities didn’t respond, Bakrim burned them.

During his defense at the Agadir court in southern Morocco, Bakrim did not deny his Christian faith and refuted accusations that he had approached his neighbors in an attempt to “undermine their Muslim faith.”

The judge ruled that “the fact that Jamaa denies accusations of proselytism is inconsistent with his previous confession in his opening statement when he proclaimed he was the son of Christ, and that he wished that Moroccans would become Christians,” according to Le Journal Hebdo.

Bakrim did not appeal the court sentence. Though there have been other cases of Christians imprisoned for their faith, none of their sentences has been as long as Bakrim’s.

“They will just leave him in the prison so he dies spiritually and psychologically,” said Rachid. “Fifteen years is too much for anything they say he did, and Jamaa knows that. The authorities know he’s innocent. So probably they gave him this sentence so they can shut him [up] forever.”

Rachid asked that Christians around the world continue to lobby and pray that their Moroccan brothers and sisters stand firm and gain their freedoms.

“The biggest need is to stand with the Moroccan church and do whatever it takes to ask for their freedom of religion,” said Rachid.

Report from Compass Direct News