How do we actually investigate rare COVID-19 vaccine side-effects?


from www.shutterstock.com

Nicholas Wood, University of Sydney and Kristine Macartney, University of SydneyInvestigations are under way to determine whether the deaths of two people in New South Wales who developed blood clots are linked to the AstraZeneca vaccine.

We’ve also heard today that 11 Australians have so far developed blood clots (thrombosis with thrombocytopenia syndrome) linked with the vaccine.

But what are these investigations? And who decides whether events like these are actually linked to COVID-19 vaccines, or something else?




Read more:
I’m over 50 and can now get my COVID vaccine. Is the AstraZeneca vaccine safe? Does it work? What else do I need to know?


What triggers the process?

There is a lot of interest in the safety of COVID-19 vaccines. So the public and health-care workers are “highly tuned in” to reporting suspected side-effects.

Anyone can report these to Australia’s drug regulator, the Therapeutic Goods Administration (TGA). Alternatively, people who have been vaccinated can do so when prompted with a survey via the AusVaxSafety system.

This is a good thing as it means we are likely to pick up any serious or unusual events. Every report is valuable and contributes to our safety monitoring. However, just because an event happened after a vaccine does not mean the vaccine caused it.

A serious event could be caused by an underlying medical condition, a medication the person was taking at the time, or some other factor unrelated to the vaccine.

For example, before COVID-19 and vaccines against it, dozens of people across Australia developed blood clots, in their legs, lungs, brain and other parts of the body, every day, often without warning or clear cause.




Read more:
COVID vaccines have been developed in record time. But how will we know they’re safe?


What happens next?

When a person has a suspected vaccine side-effect it is usually reported to the state or territory health department; some reports go directly to the TGA.

Most reactions reported after vaccination are mild to moderate. AusVaxSafety surveys in more than 365,000 people in Australia confirm what we saw in vaccine trials. Up to two-thirds of people experience symptoms such as fever, muscle aches, joint pains and headache within the first one or two days after vaccination, which go away without treatment. This is the immune system responding to the vaccine.

What if it’s serious?

If the person dies or had a serious event needing hospitalisation within the days to weeks after vaccination — like the clotting cases you will have heard about, or there was an unusual unexpected event — there are further investigations.

Health department and TGA staff gather as much information as possible about the person, including their medical history, risk factors, any medications they are on, details and timing of the vaccine, hospitalisation records, any laboratory test results and whether they have recovered or have any ongoing issues. This will involve liaising with the person’s GP, specialists and the hospital.

Many states and territories then convene an expert panel of doctors to discuss a serious case. These panels often include the treating doctor, discuss the case in detail and may advise extra tests that may help them understand the event.

A full clinical dossier is then provided to the TGA, which then further reviews the case and decides whether a group of independent expert advisors, known as a “vaccine safety investigation group” or VSIG, is needed to review the case in detail and assess if the vaccine caused it.

The VSIG often includes independent medical experts in vaccine safety, infectious diseases, haematology, public health and vaccine confidence, other medical specialists, and a consumer representative.

Socially distanced meeting, with videocall
An independent panel of advisers meet to review the case in detail and to report to the TGA.
from www.shutterstock.com

The group reviews the clinical details of the event. It then uses an internationally accepted method to rate the level of certainty of a link between the serious event and the vaccine.

First, the group determines if there is enough clinical information to come to a decision, and if not, will request further information from the state/territory health department and may need to reconvene when that information is available.

The group then determines if the case is classified as:

  • caused by the immunisation process (such as errors in vaccine technique) or the vaccine itself (the official terminology is “consistent causal association to immunisation”)
  • uncertain if the vaccine or immunisation process caused the event (“indeterminate”)
  • a coincidence (“inconsistent causal association to immunisation”). This could when because an underlying condition or something other than vaccine was the cause.

The TGA then publishes the results of this independent assessment on its website. This is accompanied by a summary of the case(s) and extra clinical advice for doctors. The TGA also feeds the results back to the state/territory health department and treating doctor.

This information will also be included in weekly updates published on the TGA website and is reviewed by other key advisory groups, including the Australian Technical Advisory Group on Immunisation and the government, who monitor the progress of immunisation programs, including for COVID-19.

Here’s the context

While such serious vaccine-related events grab the headlines, it’s important to remember they are rare. Most side-effects are mild-to-moderate and short-lived. On the other hand, the benefits of COVID-19 vaccination in ending the pandemic are enormous.

When concerning events occur after vaccination, it’s important to know Australia has strong systems to properly investigate them, look at any possible link and communicate the results to the public.




Read more:
A balancing act between benefits and risks: making sense of the latest vaccine news


The Conversation


Nicholas Wood, Associate Professor, Discipline of Childhood and Adolescent Health, University of Sydney and Kristine Macartney, Professor, Discipline of Paediatrics and Child Health, University of Sydney

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

Can I choose what vaccine I get? What if I have allergies or side-effects? Key COVID vaccine rollout questions answered


Marc Pellegrini, Walter and Eliza Hall Institute

Australia’s keenly awaited COVID vaccine rollout begins today, with the ultimate goal of vaccinating all Australians by October.

Here are the answers to some key questions.

Can I choose which vaccine I get?

No, there won’t be a choice for the average person. The current initial rollout of the Pfizer vaccine isn’t enough doses to vaccinate all of Australia. So the first people vaccinated with the Pfizer vaccine will be frontline health-care workers, including aged care and hotel quarantine officers.

The AstraZeneca vaccine will be produced for the general public. It’s hoped that will be rolled out during March.

I can’t say how the logistics will run — that’s up to the government, presumably on a state-by-state basis. Most likely they will try to prioritise the highest-risk groups such as the elderly and people with chronic health conditions.

For most people it will be a case of waiting for further announcements as to when enough vaccine is available and it’s appropriate to make an appointment. Children are unlikely to be included in the vaccination program.

Infographic on COVID vaccine rollout

The Conversation, CC BY

How will I be monitored for side-effects?

As doctors, when we vaccinate people we generally like to look after them for about 15-30 minutes, just to check they haven’t had an adverse reaction. That should be the practice for the COVID jab, just the same as for any vaccine.

For those 15-30 minutes you will generally just be sitting in a waiting area at the clinic. You will be monitored to see if you develop any symptoms such as hives or a rash, or wheezing. In those cases you would be monitored even more carefully and staff would take your blood pressure and pulse rate.

If you experience any symptoms once you’ve gone home, it would be up to you to contact your local doctor. Obviously, when trying to vaccinate 25 million people, health authorities can’t follow up with every individual. It’s very much up to them to follow up with whoever gave them the vaccine — whether their GP clinic or other health service.




Read more:
COVID vaccine consent for aged-care residents: it’s ethically tricky, but there are ways to get it right


Should I still have the vaccine if I have an allergy?

That needs to be a conversation between individuals and their doctor, who can advise on a case-by-case basis. But, generally speaking, there are no common allergies that should stop you having a COVID vaccine. If someone has a peanut allergy they can have the vaccine, and the same goes for shellfish, wheat, eggs or any other common allergies.

Some people are allergic to an ingredient called polyethylene glycol, or PEG, which is found in more than 1,000 different medications and is used in the Pfizer vaccine as a mechanism to help deliver the viral mRNA (genetic material) into your cells. In the US and UK vaccine rollouts, a very small proportion of people seemed to have an allergy to this compound: with a million doses you might see about ten people have this allergic reaction. It is rare, albeit less rare than allergic reactions to influenza vaccines.

But no one has yet died from being vaccinated against COVID, so these cases are being captured effectively and are generally detected within the initial observation period of 15-30 minutes. Severe reactions can be treated with an epipen; less severe cases are just monitored.

People might already know they’re allergic to PEG and they shouldn’t receive the Pfizer vaccine, but if they don’t know, there’s no way of knowing that in advance.




Read more:
How the Pfizer COVID vaccine gets from the freezer into your arm


The Oxford/AstraZeneca vaccine doesn’t contain PEG. It contains a related compound called polysorbate, which appears not to trigger the same allergy. If you have a known allergy to PEG you would probably be given the AstraZeneca vaccine.

It’s important to stress that these compounds are not preservatives — they are mechanisms to deliver the vaccines effectively.

Will I be fully protected? Do I still need to follow COVID restrictions?

The two vaccines have different efficacy rates — 95% for Pfizer, 62% for AstraZeneca — but these refer to their ability to prevent infection rather than disease. The fact is both are very good at preventing serious disease.

This means that, although you may still have a chance of being infected, you are much less likely to develop severe symptoms, and therefore less likely to infect others. Someone with severe COVID might be coughing and spluttering and spreading the virus more easily, while someone without symptoms might not.

Bear in mind there are two main reasons for the vaccine rollout. The first is to protect members of the public from getting very ill or dying.

The second aim is to provide a degree of immunity in the general population that will ultimately stop the virus circulating.

Of course, this second goal is much harder, which is why it’s still important that we follow any and all COVID precautions. But the hope is that over time we’ll see fewer and fewer people who are COVID-positive, and the risk of spread will fall.

Federal government information on the vaccine rollout.

Will the vaccine last forever or will I need to be revaccinated in future?

The current COVID vaccines require two doses, several weeks apart. It’s very tricky to say how long the resulting immunity will last, because globally we have only had these vaccines in use since December or so. It’s possible the immunity might last a year or longer, but at the moment it’s unclear. People might well have to be revaccinated at some stage.

We’ll start to get that data soon though. In fact we should have plenty more information by the time the AstraZeneca vaccine starts to be administered in high numbers in Australia around June or July.




Read more:
5 things you need to know about the AstraZeneca vaccine now the TGA has approved it for use in Australia


Will the vaccines work against mutant coronavirus strains?

In the fullness of time I expect we’ll start to see “escaped mutant” variants of the coronavirus that can evade the vaccine or make it less effective.

To an extent that’s happened already — the AstraZeneca vaccine looks to be less effective against the South African variant than against the other current variants. Having said that, although it’s not as effective at preventing infection, it still probably has a good chance of stopping you getting seriously sick.

Because we’re not vaccinating everyone in the world, there will always be a pool of people who can incubate new viral strains, potentially giving rise to new mutant variants.

There’s no doubt the vaccines will need to be updated from time to time to deal with this.

Thankfully this process will be relatively straightforward. mRNA vaccines such as Pfizer’s can be tweaked very quickly – virtually overnight – to accommodate new mutants. It’s a bit trickier with non-mRNA vaccines such as the AstraZeneca and Chinese vaccines, but it can still be done.

Will the vaccine rollout mean no more lockdowns?

The vaccine rollout should give us a much firmer handle on the spread of the virus. We can hope to stop seeing hotel quarantine workers being infected and spreading the virus outside, which is what has prompted the recent snap lockdowns in various Australian cities.

As for whether we’ll ever find ourselves in lockdown again, well, we’ll just have to wait and see. But if we’re still persisting with hotel quarantine and hosting arrivals from overseas, the vaccine program will hopefully mean we can afford to be much more liberal with opening our borders without fear that the virus will run rife.




Read more:
The COVID vaccine is here. When and to whom will we need to prove we’ve had it?


The Conversation


Marc Pellegrini, Researcher, Walter and Eliza Hall Institute

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

How do we know the COVID vaccine won’t have long-term side-effects?



Shutterstock

Samantha Carlson, Telethon Kids Institute; Christopher Blyth, University of Western Australia; Lucy Deng, University of Sydney; Margie Danchin, Murdoch Children’s Research Institute, and Nicholas Wood, University of Sydney

As Australia’s COVID-19 vaccine rollout begins this week, many people still have questions about the safety of COVID-19 vaccines, both in the short and long term.

As vaccine experts, we hear these concerns all the time, and it’s normal to have questions about a vaccine.

The good news is that scientists have already been testing COVID-19 vaccines for months. For starters, serious side-effects are very, very rare. And, together with what we know about previous vaccines, if side-effects are going to occur, they usually happen within a few months after getting a vaccine. This is why international medical regulators, including Australia’s Therapeutic Goods Administration (TGA), require the first few months of safety data before approving new vaccines. This, plus information coming from vaccine recipients in the northern hemisphere, gives us confidence that COVID-19 vaccines are safe.

In fact, most side-effects occur within the first one or two days. And most of these are minor, such as pain at the injection site, fatigue or fever — which are signs your immune system is building a response against the thing you’ve been vaccinated against.

What do we know about long-term side effects?

Since December, more than 200 million people have received at least one dose of a COVID-19 vaccine worldwide — more than the total number of people who have been infected with the virus (112 million).

Given the sheer number of vaccines administered to date, common, uncommon and rare side-effects would have been detected by now. What’s more, we’ve been testing these vaccines in clinical trials since mid-2020, and both the Pfizer and AstraZeneca vaccines have shown excellent safety results.

This gives us confidence the vaccines that’ll be used around Australia are safe.

We’ve also seen some people raise concerns online about mRNA vaccines, such as the Pfizer-BioNTech vaccine, being a “new” technology. mRNA (or “messenger” RNA) is found in all living cells. mRNA is a message that tells cells how to make proteins that trigger the immune response inside the body. That immune response is what protects against infection if an individual is exposed to the virus. mRNA is not the same as DNA (your genes), and it cannot combine with our DNA to change our genetic code. mRNA vaccines do not affect or interact with DNA in any way. So we can be assured there’ll be no long-term DNA-altering effects from these vaccines.

What’s more, checking the safety of the vaccines doesn’t just stop after they’ve been registered for use. Once a vaccine has been introduced, ongoing monitoring of its safety is a crucial part of the vaccine development process.

Australia has a robust system for this ongoing monitoring. The system was established to detect any unexpected side-effects from vaccines (if they occur) and ensure they’re investigated promptly. This type of monitoring is standard practise in Australia for vaccines. The data about COVID-19 vaccination collected in these surveillance systems will be published weekly on the TGA website. This should reassure Australians that if there’s a new serious side-effect, we will know about it, communicate it, and act on it quickly.




Read more:
COVID vaccines have been developed in record time. But how will we know they’re safe?


Withdrawal of vaccines after introduction to the general population is a very rare event.
In the United States, a rotavirus vaccine called Rotashield led to a small increase in the number of small intestinal blockages. This prompted its withdrawal in the late 1990s. In Australia, an increased risk of febrile seizures in young children following a specific influenza vaccine was identified in 2010. It was subsequently withdrawn from use in that age group, and we now vaccinate with a different, safer flu vaccine. This vaccine is no longer available in Australia, and has been subsequently reformulated.

Both of these side-effects were observed within weeks of vaccination.

We now have improved monitoring systems in Australia to detect such serious side-effects even sooner, in the general population after clinical trials, than we did a decade ago.

But what about short-term side-effects?

Pfizer-BioNTech COVID-19 vaccine

The expected side-effects of the Pfizer vaccine have been reported from trials involving roughly 43,000 participants aged 16 years and older from the US, Argentina, Brazil and South Africa. Half of the participants received the Pfizer vaccine and half received a placebo. And as part of COVID-19 vaccine rollouts around the world, millions of people have already been given this vaccine since December, meaning we have safety data now from both clinical trials and two months of “real world” vaccination.

For those receiving this vaccine in the large clinical trials which started in July 2020, about 80% have reported pain at the injection site. Other common side-effects included fatigue, headache, muscle pain, chills, joint pain and fever.

These were most often reported one or two days after the day of vaccination, and typically only lasted about one day. While some vaccine recipients may need a day off work due to some of these side-effects, this does not indicate the vaccine is unsafe.

In trials, no difference was seen in the rate of severe side-effects between the Pfizer vaccine and placebo. Early in the US program, 21 cases of anaphylaxis were reported. It’s estimated anaphylaxis occurs at a rate of 11 in every one million recipients (0.0011%) of the Pfizer COVID-19 vaccine. Most occurred within 15 minutes, and all patients recovered. This is why it’s a good idea though to remain at the vaccine clinic for up to 15 minutes after vaccination so that treatment and care can be provided if necessary.

A further concern was raised in January, after the death of 30 very frail elderly patients in Norway after receiving the Pfizer-BioNTech COVID-19 vaccine. But investigation by the European regulator concluded these weren’t related to the vaccine, but rather to underlying conditions present before vaccination.

Oxford-AstraZeneca COVID-19 vaccine

This vaccine has been tested in ongoing trials with around 55,000 participants from the United Kingdom, Brazil, South Africa and the US. About half received the Oxford-AstraZeneca vaccine and half a placebo. Millions of doses have been already been administered among the general population, particularly in the UK.

Data from four clinical trials which commenced in April 2020 in the UK, Brazil and South Africa, show the most common side-effects were pain at the injection site, fatigue, headache and muscle pain. Similar to the Pfizer vaccine, there was no difference in the rate of reported severe side-effects for the vaccine compared with the placebo.

Just 0.7% of participants (79 people) from the four clinical trials who received the Oxford-AstraZeneca vaccine reported a serious side-effect after receiving at least one dose, compared with 0.8% (89 people) of those in the placebo group. No additional safety concerns have been identified since the vaccination program began in the UK.




Read more:
Should I get a COVID vaccine while I’m pregnant or breastfeeding? Is it safe for me and my baby?


If recommended a COVID-19 vaccine, take it

With countries continuing to monitor those who have received vaccines, we should be reassured there are no major safety concerns detected for serious side-effects so far. With millions of people vaccinated already, our confidence about the safety of COVID-19 vaccines is very high.

In Australia, and internationally, we have robust systems in place to continually monitor vaccine safety, ensuring Australians can be safely afforded the protection that COVID-19 vaccines are designed to provide.The Conversation

Samantha Carlson, Post Doctoral Research Officer, Telethon Kids Institute; Christopher Blyth, Paediatrician, Infectious Diseases Physician and Clinical Microbiologist, Telethon Kids Institute, University of Western Australia; Lucy Deng, Paediatrician, National Centre for Immunisation Research and Surveillance; Clinical Lecturer, Children’s Hospital Westmead Clinical School, University of Sydney; Margie Danchin, Associate Professor, University of Melbourne, Murdoch Children’s Research Institute, and 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.

Vaccines against SARS-CoV-2 will have side effects – that’s a good thing



A little bit of post-injection soreness is completely normal.
Jose Luis Pelaez Inc/DigitalVision via Getty Images

Matthew Woodruff, Emory University

Takeaways

  • Temporary side effects from vaccines are a normal sign of a developing immune response.

  • Vaccines work by training your immune system to recognize and remember a pathogen in a safe way.

  • Expected side effects from a COVID-19 vaccine include redness and swelling at the injection site and stiffness and soreness in the muscle.

  • A potent vaccine may even cause fever. It does not mean that the vaccine gave you COVID-19.


In 2021 hundreds of millions of people will be vaccinated against SARS-CoV-2. The success of that COVID-19 vaccination campaign will heavily depend on public trust that the vaccines are not only effective, but also safe. To build that trust, the medical and scientific communities have a responsibility to engage in difficult discussions with the public about the significant fraction of people who will experience temporary side effects from these vaccines.

I am an immunologist who studies the fundamentals of immune responses to vaccination, so part of that responsibility falls on me.

Simply put, receiving these vaccines will likely make a whole lot of people feel crappy for a few days. That’s probably a good thing, and it’s a far better prospect than long-term illness or death.

Immunology’s ‘dirty little secret’

In 1989, immunologist Charles Janeway published an article summarizing the state of the field of immunology. Until that point, immunologists had accepted that immune responses were initiated when encountering something foreign – bacteria, viruses, and parasites – that was “non-self.”

Janeway suspected that there was more to the story, and famously laid out what he referred to as “the immunologist’s dirty little secret”: Your immune system doesn’t just respond just to foreign things. It responds to foreign things that it perceives to be dangerous.

Now, 30 years later, immunologists know that your immune system uses a complex set of sensors to understand not only whether or not something is foreign, but also what kind of threat, if any, a microbe might pose. It can tell the difference between viruses – like SARS-CoV-2 – and parasites, like tapeworms, and activate specialized arms of your immune system to deal with those specific threats accordingly. It can even monitor the level of tissue damage caused by an invader, and ramp up your immune response to match.

Sensing the type of threat posed by a microbe, and the level of intensity of that threat, allows your immune system to select the right set of responses, wield them precisely, and avoid the very real danger of immune overreaction.

Vaccine adjuvants bring the danger we need

Vaccines work by introducing a safe version of a pathogen to a patient’s immune system. Your immune system remembers its past encounters and responds more efficiently if it sees the same pathogen again. However, it generates memory only if the vaccine packs enough danger signals to kick off a solid immune response.

As a result, your immune system’s need to sense danger before responding is at once extremely important (imagine if it started attacking the thousands of species of friendly bacteria in your gut!) and highly problematic. The requirement for danger means that your immune system is programmed not to respond unless a clear threat is identified. It also means that if I’m developing a vaccine, I have to convince your immune system that the vaccine itself is a threat worth taking seriously.

This can be accomplished in a number of ways. One is to inject a weakened – what immunologists call attenuated – or even killed version of a pathogen. This approach has the benefit of looking almost identical to the “real” pathogen, triggering many of the same danger signals and often resulting in strong, long-term immunity, as is seen in polio vaccination. It can also be risky – if you haven’t weakened the pathogen enough and roll out the vaccine too fast, there is a possibility of unintentionally infecting a large number of vaccine recipients. In addition to this unacceptable human cost, the resulting loss of trust in vaccines could lead to additional suffering as fewer people take other, safer vaccines.

A safer approach is to use individual components of the pathogen, harmless by themselves but capable of training your immune system to recognize the real thing. However, these pieces of the pathogen don’t often contain the danger signals necessary to stimulate a strong memory response. As a result, they need to be supplemented with synthetic danger signals, which immunologists refer to as “adjuvants.”

Adjuvants are safe, but designed to inflame

To make vaccines more effective, whole labs have been dedicated to the testing and development of new adjuvants. All are designed with the same basic purpose – to kick the immune system into action in a way that maximizes the effectiveness and longevity of the response. In doing so, we maximize the number of people that will benefit from the vaccine and the length of time those people are protected.

To do this, we take advantage of the same sensors that your immune system uses to sense damage in an active infection. That means that while they will stimulate an effective immune response, they will do so by producing temporary inflammatory effects. At a cellular level, the vaccine triggers inflammation at the injection site. Blood vessels in the area become a little more “leaky” to help recruit immune cells into the muscle tissue, causing the area to become red and swell. All of this kicks off a full-blown immune response in a lymph node somewhere nearby that will play out over the course of weeks.

In terms of symptoms, this can result in redness and swelling at the injection site, stiffness and soreness in the muscle, tenderness and swelling of the local lymph nodes and, if the vaccine is potent enough, even fever (and that associated generally crappy feeling).

This is the balance of vaccine design – maximizing protection and benefits while minimizing their uncomfortable, but necessary, side effects. That’s not to say that serious side effects don’t occur – they do – but they are exceedingly rare. Two of the most discussed serious side effects, anaphalaxis (a severe allergic reaction) and Guillain-Barré Syndrome (nerve damage due to inflammation), occur at a frequency of less than 1 in 500,000 doses.

Side effects are normal.

Vaccination against SARS-CoV-2

Early data suggest that the mRNA vaccines in development against SARS-CoV-2 are highly effective – upwards of 90%. That means they are capable of stimulating robust immune responses, complete with sufficient danger signaling, in greater than nine out of 10 patients. That’s a high number under any circumstances, and suggests that these vaccines are potent.

So let’s be clear here. You should expect to feel sore at the injection site the day after you get vaccinated. You should expect some redness and swelling, and you might even expect to feel generally run down for a day or two post-vaccination. All of these things are normal, anticipated and even intended.

While the data aren’t finalized, more than 2% of the Moderna vaccine recipients experienced what they categorized as severe temporary side effects such as fatigue and headache. The percentage of people who experience any side effects will be higher. These are signs that the vaccine is doing what it was designed to do – train your immune system to respond against something it might otherwise ignore so that you’ll be protected later. It does not mean that the vaccine gave you COVID-19.

[Deep knowledge, daily. Sign up for The Conversation’s newsletter.]

It all comes down to this: Some time in the coming months, you will be given a simple choice to protect yourself, your loved ones and your community from a highly transmissible and deadly disease that results in long-term health consequences for a significant number of otherwise healthy people. It may cost you a few days of feeling sick.

Please choose wisely.The Conversation

Matthew Woodruff, Instructor, Lowance Center for Human Immunology, Emory University

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

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



Shutterstock

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.




Read more:
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.
www.shutterstock.com

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.




Read more:
Vaccine progress report: the projects bidding to win the race for a COVID-19 vaccine


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.




Read more:
The vaccine we’re testing in Australia is based on a flu shot. Here’s how it could work against coronavirus


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