Worksafe’s hotel quarantine breach penalties are a warning for other employers to keep workers safe from COVID

Posted on October 16, 2021 by particularkev

Alex Collie, Monash UniversityVictoria’s occupational health and safety regulator, Worksafe, has charged the state’s health department with 58 breaches for failing to provide hotel quarantine staff with a safe workplace.

The breaches occurred between March and July 2020, and at up to A$1.64 million per breach, could amount to fines of $95 million.

This should serve as a warning to all employers to start assessing their workers’ safety against COVID and how they can mitigate these risks, ahead of the nation reopening.

Remind me, what is Worksafe?

States and territories have responsibility for enforcing laws designed to keep people safe at work: occupational health and safety (OHS) laws.

Worksafe Victoria is responsible for and regulates OHS in Victoria. It’s responsible for making sure employers and workers comply with OHS laws; and it provides information, advice and support.

Victoria’s parliament has given Worksafe the power to prosecute employers if they breach OHS laws. In 2018-19, it commenced 157 prosecutions which resulted in nearly A$7 million in fines.

Unlike some other state OHS regulators, Worksafe also manages the Victorian workers’ compensation system.

Why did Worksafe charge the health department?

Worksafe charged Victoria’s Department of Health with 58 breaches of sections 21 and 23 of the Victorian Occupational Health and Safety Act.

The Act requires employers to maintain a working environment that is “safe and without risks to health” of employees. These obligations extend to independent contractors or people employed by those contractors.

Worksafe is alleging that in operating the Victorian COVID-19 quarantine hotels between March and July 2020, the Department of Health failed to maintain a working environment that was safe and limited risks to health, both to its own employees and to other people working in the hotels.

Essentially Worksafe is stating that through a series of failures, the department placed government employees and other workers at risk of serious illness or death through contracting COVID-19 at work.

Worksafe alleges the Victorian health department failed to:

appoint people with expertise in infection control to work at the quarantine hotels
provide sufficient infection prevention and control training to security guards working in the hotels, as evidence shows training can improve employees’ safety practices
provide instructions, at least initially, on how to use personal protective equipment, and later did not update instructions on mask wearing in some of the quarantine hotels.

Worksafe undertook a 15-month long investigation, beginning in about July 2020. It’s possible the trigger for this investigation was a referral from the Coate inquiry into hotel quarantine, but that has not been stated.

Is it unusual for a government regulator to fine a government department?

It’s not that unusual. Government departments are subject to the same OHS laws as other employers in the state, and so Worksafe’s powers extend to them as well.

In the past few years, Worksafe has successfully prosecuted the Department of Justice, Parks Victoria and the Department of Health, resulting in fines and convictions.

In 2018, for example, Worksafe prosecuted Corrections Victoria (part of the Department of Justice) after a riot at the Metropolitan Remand Centre in 2015 that put the health and safety of staff at risk.

The riot occurred after the introduction of a smoking ban in prisons. Worksafe considered prisoner unrest was predictable and its impact on staff could have been reduced by having additional security in place in the days leading up to the smoking ban.

In that case the Department of Justice pleaded guilty and was convicted and fined A$300,000 plus legal costs.

What does this mean for other employers?

This case highlights that employers have obligations to provide safe working environments for their staff, and other people in their workplaces. This extends to reducing risks of COVID-19 infection.

These obligations don’t just apply to government departments. They apply to every employer in the state.

Employers should ensure they have appropriate systems and policies in place to reduce COVID-19 infection risk to their staff. This includes, where appropriate, physical distancing, working from home, wearing personal protective equipment (PPE), good hygiene practices, workplace ventilation, and so on.

Employers should consider the risks unique to their environment and address them appropriately, in advance of the nation reopening when we reach high levels of COVID vaccination coverage.

Some employers in high-risk settings – such as health care, retail and hospitality – will need to do more to protect their workers than others.

What happens next for the Vic health department?

The case has been filed in the Magistrates court, with an initial hearing date set for October 22. It will progress through the court system from there. Most prosecutions are heard in the Magistrates Court although some proceed to the County Court.

If the Department of Health pleads guilty, the courts will determine if a fine should be paid and how much. The court may also determine if a conviction is recorded.

Alex Collie, Professor and ARC Future Fellow, Monash University

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

Keeping workers COVID-safe requires more than just following public health orders

Posted on October 14, 2021 by particularkev

Stephen Duckett, Grattan InstituteSo far in the pandemic, state public health advice has been front and centre of public messaging about protecting the community from the spread of COVID-19.

But merely following the public health orders won’t necessarily meet employers’ obligations to protect staff from COVID, especially as restrictions ease in the Eastern states.

Protecting employees from COVID is good for staff, of course, and also good for the organisation because it will reduce the potential for staff being off sick.

Vaccination alone won’t guarantee a COVID-safe workplace. Even double-vaccinated people can be infected. Vaccination reduces the chance of infection by between 60% (AstraZeneca) and 80% (Pfizer). And double-vaccinated people can also transmit the virus, although again at a much lower rate.

As part of the scientific advisory group OzSAGE, we’re issuing guidance to employers about creating COVID-safe working environments. We propose organisations follow a four-level hierarchy of COVID controls.

Employers need to consider four key areas.
OzSAGE

Level 1: vaccination and working from home

The most effective protections against COVID are vaccinating to reduce the risk of infection, and limiting interactions with infected people. These are the two standard public health measures seen in state public health orders.

Employers should encourage employees to get vaccinated by providing:

leave or paid time off to get vaccinated
reliable and up-to-date information on the effectiveness of vaccinations
the details of the locations nearby where vaccinations are available
on-site vaccination, if possible, for shift workers and those who can’t easily attend a GP or vaccine hub appointment
incentives, such as additional annual leave days for vaccinated workers.

In some circumstances – especially where the organisation is responsible for caring for people at a higher risk of infection – mandatory vaccination of employees might also be considered.

Staff should be encouraged to work from home if that’s possible, while risk of infection is still high. Working from home doesn’t eliminate the risk of COVID, but it eliminates the risk of contracting (and transmitting) COVID in the workplace.

Putting in place “hybrid” working arrangements reduces the number of people in the workplace at any one time, and therefore the risk of transmission.

Level 2: safe indoor air

State public health orders have essentially focused on density limits. These are important, but don’t guarantee good ventilation and clean air.

COVID spreads by aerosols. Respiratory aerosols from breathing and speaking accumulate in indoor spaces, resulting in increasing risk over time.

Poor ventilation (stagnant air) in public buildings, workplaces, schools, hospitals, and aged care homes contributes to viral spread.

Masked woman with a clipboard surveys a storeroom. — Poor ventilation is a risk for transmitting COVID.
Shutterstock

Good ventilation is a key part of reducing the risk of COVID transmission.

As the number of people inside a space increases, CO₂ will increase to varying degrees, depending on the effectiveness of ventilation and the volume of the space. Measuring carbon dioxide (CO₂) is therefore a useful surrogate indicator to assess the relative infection risk of COVID in an indoor space.

It’s recommended employers invest in CO₂ monitoring and use that as a trigger to reduce occupancy and/or increase the provision of outdoor air and HEPA (high-efficiency particulate air) filtering to ensure the risk of COVID-19 is appropriately mitigated.

Having automated alerts (in non-HEPA filtered areas) from CO₂ monitors will prompt action to improve ventilation or leave the workplace.

Level 3: administrative measures

Organisations should be ready to manage COVID outbreaks – especially in New South Wales and Victoria, where public health contact tracing is at capacity.

Organisations might also use regular rapid antigen testing (where practical and feasible, considering cost and logistics), to prevent or limit outbreaks when people are shedding the virus but are asymptomatic.

Man holds rapid COVID testing stick. — Rapid tests can help detect COVID in those with no symptoms.
Shutterstock

The risk of an organisation-wide shutdown can be minimised by creating work bubbles – teams coming to work on different days – and other measures to reduce physical interactions.

Staggering work hours to reduce congregating at lift spaces is another useful, low-cost strategy.

Level 4: masks

COVID-19 is an airborne disease, so the use of masks is integral to reduce transmission and to offer some protection if there is any breakdown of other controls.

Masks are also essential because 30–70% of transmission may be asymptomatic: from infected people who look and feel well and may not be aware they are infected.

Basic cloth masks and surgical masks reduce the transmission of COVID. The effectiveness of masks increases when they fit snugly on the wearer’s face.

Workers should be provided with appropriate fitted masks and should be trained in how and when to use them. At a minimum, where workplaces are in areas with community transmission of COVID, masks should be worn whenever workers are indoors.

Rates of COVID are still high in NSW, Victoria, and the ACT. Employers, especially in those jurisdictions, should review their work health and safety plans to ensure their workers and customers are properly protected.

This article was co-authored by occupational and environmental physician Karina Powers, engineer and scientist Kate Cole, Flinders University Professor Richard Nunes-Vaz, and other members of the OzSAGE advice for business working group.

Stephen Duckett, Director, Health and Aged Care Program, Grattan Institute

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

Opening up when 80% of eligible adults are vaccinated won’t be ‘safe’ for all Australians

Posted on September 8, 2021 by particularkev

Anne Kavanagh, The University of Melbourne; Helen Dickinson, UNSW, and Nancy Baxter, The University of MelbourneWe’ve all grown tired of lockdowns, border closures and other restrictions. So the promise of a freer life, when 70% and then 80% of Australians aged 16 and older are vaccinated, feels like a beacon on the horizon.

Prime Minister Scott Morrison, some premiers, and leading public servants have promised us at 80% we can live “safely” with COVID-19, or come out of our “caves” in the PM’s parlance.

The narrative is one of Team Australia and we are “all in this together”. But are we really?

Risks of COVID-19 infection, serious disease and death are not equitably distributed. They disproportionally cluster among the most disadvantaged. Vaccine access and uptake is also lower in many disadvantaged groups.

Opening the country at 80% without ensuring these groups have met or exceeded those targets will result in substantial avoidable illness and death.

Who is most vulnerable to serious disease?

The risk of serious COVID-19 and death is related to “clinical vulnerability”, such as whether the person has underlying health conditions like diabetes or respiratory disease.

First Nations Australians, disabled Australians, prisoners and people living in rural and remote Australia have much higher levels of chronic conditions, which have their roots in social and economic disadvantage.

On top of their clinical vulnerability, these groups face multiple barriers to accessing quality health care, including intensive care. These barriers might include lack of physical access, discrimination, an inability to access culturally competent care, and/or geographical distance.

What have we learnt from other countries?

Across the world, COVID-19 infection rates have occurred at higher rates in aged-care facilities, disability group homes and institutions and jails.

Besides aged-care residents, Australia hasn’t yet seen the high death rates in clinically vulnerable groups that other countries have witnessed.

In the United States, Indigenous Americans have had the highest rate of COVID-19 deaths – dying at three times the rate of white Americans (when adjusting for the fact that Indigenous Americans are younger than non-Indigenous Americans).

High rates of death have also been seen among:

Black and Hispanic Americans
those in rural areas
prisoners, who were three times as likely than the rest of the population to die of COVID-19 (after taking into account the differences in age and sex between the prison and general populations).

Hospital equipment sits in front of clinicians in scrubs. — The death rate among clinically vulnerable groups has been up to three times higher in the US.
Stacey Plaisance/AP

In the United Kingdom, people with intellectual disability were eight times more likely than the rest of the population to die of COVID and disabled people made up 60% of the deaths.

Intellectual disability was second only to age as a risk factor for death from COVID-19 in the US.

What’s happening in Australia?

COVID-19 infections are more common in disadvantaged areas, both in Australia and internationally.

Residents in disadvantaged communities are more mobile, live and work in close proximity to other people, and are more likely to be essential workers who can’t work from home. These areas also tend to have high concentrations of ethnic minority and migrant communities.

Victoria’s second wave included outbreaks among residents and workers in aged-care facilities, along with outbreaks in health care, meatworks, and disability group homes.

In NSW’s current wave, outbreaks are spreading rapidly in First Nations communities in western NSW and in prisons.

Who is getting vaccinated?

Australia’s vaccine rollout strategy prioritised people at most risk of serious disease and death from COVID-19.

Phase 1A included aged-care and disability group home residents and the workers who support them.

In Phase 1B, First Nations Australians over 55 years and people with disability with chronic conditions were eligible.

People prioritised in these phases were meant to be vaccinated by April.

More recently, all participants in the National Disability Insurance Scheme and Indigenous Australians 12 years and older became eligible.

Prisoners are not explicitly included as a priority population.

But the strategy came without an implementation plan and vaccination levels are appallingly low in many groups.

Vaccination rates are substantially lower among Indigenous Australians than the population rates in every state and territory, except Victoria where Indigenous vaccination rates are much higher.

In western NSW, where COVID-19 is rapidly spreading through First Nations communities, 11.6% if Indigenous Australians are fully vaccinated compared with 28.9% of non-Indigenous Australians.

Information about vaccination rates among disabled people and workers are not routinely shared and tend to be leaked to the media. On August 22, for example, the Sunday Age revealed just 27% of NDIS participants were fully vaccinated, lagging behind the national rate.

Vaccination of prisoners and prison staff has also been slow. Many states only started their prison vaccination rollout in the last couple of months and data on vaccination coverage in correctional services have not been released (or perhaps even collected).

No targets yet for vaccinating vulnerable groups

The Doherty-led COVID-19 vaccination modelling is cited as justifying the federal government’s 80% target. The modelling report acknowledges:

particular attention should be paid to groups in whom socioeconomic, cultural and other determinants are anticipated to result in higher transmission and/or disease outcomes.

The Doherty Institute’s director, Professor Sharon Lewin, emphasised that we need to achieve 80% targets for all Australians including our most disadvantaged citizens.

However, the model itself did not specifically evaluate the potential impact on high-risk groups. Nor does the Commonwealth National Transition Plan focus on equity.

Disadvantaged Australians face triple jeopardy – low vaccination rates, greater likelihood of being infected with COVID-19, and higher risks of serious disease and death from COVID-19.

These risk factors are significant individually. But some individuals face intersectional disadvantage. Indigenous people, for example, experience disability at a higher level than the general population. And people with mental health issues are over-represented in prisons.

Until now, we have relied on public health measures to contain the spread of COVID-19. If we relax these and move quickly to rely mainly on vaccination without ensuring equitable delivery, those most at risk will face a disproportionately greater burden of serious illness and death.

What can be done?

Thankfully, vaccine supply is improving. Australians are being vaccinated at unprecedented levels, particularly in NSW.

However, unless we explicitly move to an equity-based strategy for vaccination, “at risk” populations will be left even further behind.

Man in a mask shops for dip. — All Australians should have an opportunity to be vaccinated before the nation opens up.
Atoms/Unsplash

Equitable allocation of vaccines requires:

defining priority groups and geographical areas
allocating an increased share of vaccines or vaccination appointments
tailoring outreach and communication
offering vaccinations close to or in workplaces and places where people live including private homes, aged-care facilities, and prisons
monitoring vaccination uptake
inclusion of vaccine targets for priority groups in the national plan.

Continuing our current strategy will mean that when we decide the time is right to “live with COVID”, many people who should have been the highest priority for vaccination could die.

We demand a rethink of our vaccine strategy to have an explicit focus on equitable vaccine allocation. Otherwise, it’s simply not “safe” for many Australians to come out of Morrison’s proverbial cave.

Anne Kavanagh, Professor of Disability and Health, Melbourne School of Population and Global Health, The University of Melbourne; Helen Dickinson, Professor, Public Service Research, UNSW, and Nancy Baxter, Professor and Head of Melbourne School of Population & Global Health, The University of Melbourne

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

From vaccination to ventilation: 5 ways to keep kids safe from COVID when schools reopen

Posted on September 7, 2021 by particularkev

C Raina MacIntyre, UNSW; Greg Kelly, The University of Queensland; Holly Seale, UNSW, and Richard Holden, UNSWLast week the New South Wales government announced schools are scheduled to re-open in October. While face-to-face learning undoubtedly has benefits for both children and parents, the announcement left unanswered a series of important questions about how this can be done safely.

By the time NSW lifts restrictions (estimated to be around October), only 60-70% of the population in NSW — and possibly less in Australia — who are 16 years and over may be fully vaccinated.

The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended vaccination for children 12 and over, but most of these children will not be fully vaccinated by October, and children under 12 will remain unvaccinated for now.

In NSW, with well over 1,000 cases a day and rising, there will still be substantial community transmission when schools open. It is unclear when schools in Victoria (where cases are also on the rise) will open, but there may still be some transmission in the state when they do.

So, what do we need to do to make sure kids are as safe as possible at school?

1. Vaccinate the adults around them

In California, a primary school outbreak occurred when an unvaccinated teacher, who came to work despite symptoms, read to students with their mask off. Most kids who became infected were well over 2 metres from the teacher, which confirms the 1-2m distancing rule is not effective for an airborne virus.

Every child and teacher in a classroom or childcare centre with an infected person is at risk. Shared air is the major way SARS-CoV-2 — the virus that causes COVID-19 — spreads.

Children often get the virus from the adults around them, so vaccinating adults in a child’s household, and teachers, can help protect them.

Vaccination is now mandatory for teachers in NSW, but around 67% have had one dose. This probably corresponds to less than 40% of the NSW population being fully vaccinated.

Teacher reading books to kids sitting on the floor. — Anyone in the same room with an infected person, especially if that person isn’t wearing a mask, is at risk of catching the virus.
Shutterstock

One dose of vaccination gives about 31% protection and two doses gives 67% (AstraZeneca) to 88% (Pfizer) protection against the Delta variant. Most kids will still be unvaccinated if schools in the two largest states re-open for the last term of the year. This means it’s even more important to ensure the adults are vaccinated.

2. Mandate masks for teachers and students

We can mandate masks in schools for teachers and students, and highly recommend mask use for younger children in childcare.

The American Academy of Pediatrics recommends masks for children two years and up; children over this age can wear masks without much trouble.

As mask use in schools has been more common overseas, there are now numerous toolkits (including translated versions) and recommendations to support children to wear a mask. For example, your child is more likely wear a mask if it has their favourite colour, sports team, character or special interest on it.

Importantly, a DIY cloth mask can be made to fit your child’s face and be high quality if key design principles are followed. It is important to ensure children have choices and understand the reason why they are wearing a mask (for instance: “When we wear a mask, the virus can’t jump from person to person.”

3. Ventilated classrooms

Classrooms can be ventilated by opening windows (ideally two windows at opposite ends of the room). If there is only one window, a fan can help move the dirty air out. If opening windows is not possible there is fortunately a cheap fix available — portable air purifiers, which dramatically reduce the viral load in classrooms.

There are DIY methods for making air purifiers, too.

4. Reduce numbers of people indoors

Reducing the number of people packed together in a classroom can reduce the risk of COVID. For example, during high epidemic periods, if the decision is made to open schools, a group of kids can come in every second day and learn online on alternate days.

We have shown this approach, when combined with masks, reduces the risk of transmission on university campus.

Use of outdoor spaces for lessons is also a smart move as the weather gets warmer. While Delta can transmit outdoors, the risk is likely much lower.

5. Test school kids

Finally, rapid point-of-care testing in schools will help reduce transmission, and self-testing kits (when approved in Australia) can help.

Saliva tests are also a practical way to test children. These tests are now available in official health settings, so governments could make them available to schools.

What about childcare centres?

We also need to consider childcare centres. Contrary to popular narrative, a new study shows kids up to three years old transmit more than older kids. So, vaccinating childcare workers and parents of young kids is also essential.

All the measures above, except masks for 0-2 year olds, can easily be used in childcare settings.

Girls getting swabbed in the mouth. — Rapid testing in schools could help reduce transmission.
Shutterstock

Record numbers of children are being hospitalised with COVID-19 in the USA. It remains unclear whether the high numbers of sick children are due mostly to Delta’s increased transmissibility, or whether it also causes more severe disease in children, as it does in adults. Although the risk of severe disease remains much lower in children than adults.

One thing we do know is that as vaccination rates increase in adults, unvaccinated groups, the largest of which is children, will be proportionally more at risk. The 70-80% targets for vaccination of eligible adults for relaxing restrictions corresponds to 56-64% of the whole population, which leaves plenty of room for Delta to spread like wildfire in unvaccinated adults and kids. So there is good reason to protect kids if we open schools.

In addition, the productivity losses from lockdowns are an important component of the estimated A$220 million daily economic cost in NSW alone. Sick kids make it harder for their parents to work productively, if at all. And they make it more likely parents themselves become sick and are unable to work.

C Raina MacIntyre, Professor of Global Biosecurity, NHMRC Principal Research Fellow, Head, Biosecurity Program, Kirby Institute, UNSW; Greg Kelly, Senior lecturer, The University of Queensland; Holly Seale, Associate professor, UNSW, and Richard Holden, Professor of Economics, UNSW

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

Growing evidence suggests Russia’s Sputnik V COVID vaccine is safe and very effective. But questions about the data remain

Posted on July 29, 2021 by particularkev

Megan Steain, University of Sydney and Jamie Triccas, University of SydneyRussia was the first country to register a COVID vaccine, with its health ministry giving emergency approval to the Sputnik V vaccine in August 2020.

This decision was met with scepticism from the international scientific community because it came a month before results of phase 1 and 2 trials were published.

Growing data from clinical trials and real world rollouts suggests the vaccine is safe and very effective. But there are several outstanding questions around the vaccine, such as whether it’s associated with the very rare blood clotting condition seen with AstraZeneca’s vaccine, and how well it performs against variants of the coronavirus.

So what kind of vaccine is Sputnik V, how does it work, and what data are we missing?

How does Sputnik V work?

Sputnik V was designed by The Gamaleya National Research Center for Epidemiology and Microbiology. It has its very own Twitter account advertising its status as the “world’s first registered COVID-19 vaccine” and approval in 69 countries including Russia, South Korea, Argentina and the UAE.

Like the Oxford-AstraZeneca vaccine, the basis for the vaccine is a harmless form of adenovirus, one of several viruses that can cause the common cold.

The adenovirus acts as a packaging system for DNA to deliver instructions to our cells. This DNA instructs cells to make the spike protein from SARS-CoV-2. The immune system is then trained to generate an immune response to the spike protein, which provides protection against the real SARS-CoV-2 virus.

Unlike the other adenovirus-based vaccines, Sputnik V uses two different adenoviruses for the first and second dose. This is done as people can develop an immune response against the adenovirus vector used in the first shot of the vaccine, which could possibly reduce the overall effectiveness.

The two doses are separated by three weeks, rather than the 8-12 weeks usually recommended for the Oxford-AstraZeneca vaccine.

Sputnik V doesn’t require the ultra-cold temperatures like the mRNA-based vaccines, which makes it an attractive candidate for many countries desperate for vaccines. Gamaleya has been open to sharing its manufacturing platform, unlike some other vaccines.

How well does Sputnik V work against COVID-19?

Data from the phase 1 and 2 clinical trial was published in September in the highly reputed medical journal The Lancet. The data showed no major adverse reactions, and side effects that were common to the other COVID-19 vaccines. These were primarily fever, headaches and pain at the injection site.

Most impressively were the results of the larger phase 3 trial published in The Lancet in February this year, which reported 91.6% efficacy against symptomatic infection. This places Sputnik on par with the mRNA vaccines by Pfizer and Moderna, for which the original efficacies were 95% and 94.1% respectively.

The results from the phase 3 trial also suggested a single dose was protective, with an efficacy of 79.4%. This led to the approval of “Sputnik Light” in some countries, a single dose regimen that overcomes some of the issues manufacturing the second dose of Sputnik V. The two different adenoviruses used in the first and second dose of Sputnik V need to be produced using separate cell cultures. Only having to produce a single type of adenovirus streamlines the production.

Outside of these trials, a press release from Gamaleya says real world analysis of the vaccine given to nearly 3.8 million Russians reported an efficacy of 97.6% against infection. This led Gamaleya to claim Sputnik V is “the world’s most effective vaccine”.

Despite the encouraging efficacy results, there are still some concerns. Both the phase 1 and 2 safety trials, and the phase 3 efficacy trials, have been criticised for not sharing their raw data or the full details of their study design, as well as inconsistencies in the published data.

Sputnik V isn’t yet approved by the European Medicines Agency (EMA) or the World Health Organization, meaning it cannot be used by COVAX, the COVID vaccine global access initiative. Gamaleya has yet to provide the EMA with all the necessary manufacturing and clinical data necessary to gain this approval.

What are the unanswered questions about Sputnik V?

There are a number of outstanding issues with the vaccine.

Of particular importance is the question of whether it’s associated with the very rare blood clotting condition that’s been linked to the AstraZeneca and Johnson and Johnson vaccines, which also use adenovirus vectors.

Gamaleya claims there have been no reports of this occurring in individuals given Sputnik V. Analysis following the administration of 2.8 million doses of Sputnik V in Argentina supports this. The results, announced via a press release by the Argentine health ministry, reported no deaths associated with vaccination and showed mostly mild adverse events.

And there was no indication of an association between Sputnik V and this condition in the clinical trials.

However, there hasn’t been enough published real world data to be completely confident researchers would be able to pick up on the condition if it did emerge.

It’s also unclear how well Sputnik performs against the rapidly spreading variants of concern, such as Delta. Some of these variants are partially able to escape from the immune response generated by COVID vaccines.

Research published in July examined antibodies in the blood of people vaccinated with Sputnik V to see how it performed against the Alpha, Beta, Gamma and Delta variants. It found there was a reduction in the ability of their antibodies to block infection. It’s unclear how this reduction would impact the vaccine’s effectiveness against hospitalisation and death, as we’re still waiting to see published real world data on this.

We need further studies which directly compare blood samples from people vaccinated with the different vaccines before Sputnik’s claims of being highly effective against variants can be confirmed. We’ll also need to see real world analysis of its effectiveness against variants, such as that performed with Pfizer and AstraZeneca.

Megan Steain, Lecturer, School of Medical Sciences, Faculty of Medicine and Health, University of Sydney and Jamie Triccas, Professor of Medical Microbiology, School of Medical Sciences, Faculty of Medicine and Health, University of Sydney

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

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?

Posted on May 4, 2021 by particularkev

Meru Sheel, Australian National University; Cyra Patel, Australian National University, and Margie Danchin, Murdoch Children’s Research InstituteFrom today, Australians aged 50 or older are eligible to receive their COVID-19 vaccine from special respiratory clinics or mass vaccination hubs in some states. Appointments with selected GPs are available from May 17.

However, a recent poll shows many people over 50 are hesitant to get vaccinated, particularly with the AstraZeneca vaccine earmarked for them. That’s mostly due to reports of very rare, but serious, blood clots that can develop after vaccination.

So it’s understandable why people want to know about any safety issues and how they relate to age. It’s also natural to want to know how well the vaccine works to protect people over 50.

Here’s what we know about this safe and effective vaccine from clinical trials and around 136 countries using it so far.

Does the AstraZeneca vaccine protect people over 50?

Clinical trials, which have included more than 57,000 people to date, found the AstraZeneca vaccine to be safe and effective.

When researchers pooled the results from four large trials — including about 8,600 vaccinated people and a similar number of unvaccinated persons — there were 81% fewer COVID-19 cases in vaccinated people than in unvaccinated ones. No one who got the vaccine was hospitalised due to COVID-19.

While the studies haven’t been designed specifically to look at efficacy in distinct age groups yet, there is good evidence the AstraZeneca vaccine protects both the elderly and younger adults from COVID-19. In clinical trials, adults aged 18-55 and those older than 55 had similar immune responses.

How about serious disease and death?

When it comes to protecting people from serious disease, there’s good news again. We have data from England and Scotland that one dose of it reduces COVID-19 hospitalisations by 80-88% in the elderly, similar to that of the Pfizer vaccine (88-91%).

Based on our understanding of how vaccines work — generally, vaccines are more effective in younger adults — it’s safe to assume the vaccine is at least 80% effective in preventing severe COVID-19 in people over 50.

Emergency sign — We want to avoid people ending up in hospital with serious COVID-19. With the AstraZeneca vaccine, hospitalisations are down around 80%.
from www.shutterstock.com

What about the new variants?

New variants of SARS-CoV-2, the virus that causes COVID-19, affect the efficacy of the AstraZeneca vaccine, but only slightly for the B.1.1.7 strain (the UK variant). It’s about 70% effective against this strain, compared with about 82% for the original strain.

However, there have been some concerns about protection against the B.1.351 strain (the South African variant). This is because the AstraZeneca vaccine provides less protection against mild COVID-19 disease in people infected with it.

Does the AstraZeneca vaccine limit spread of COVID-19?

We still need more long-term data to say for certain whether the vaccine prevents transmission of COVID-19.

However, preliminary UK research provides some welcome news. Researchers looked at more than 365,000 households and nearly one million contacts of COVID-19 cases. They found the vaccine reduced transmission from people vaccinated with one dose by 40-50%. This is great news in terms of slowing the spread of the disease.

How safe is the AstraZeneca vaccine in people over 50?

Both clinical trials and real-world data confirm the AstraZeneca vaccine has a good safety profile similar to other vaccines commonly used in Australia.

Side-effects are common and are mostly mild to moderate, with few recipients needing medical attention. The most common are reactions at the injection site, fatigue, headache and muscle pain. These occur in half to three-quarters of people under 55 after their first dose, and are less common in older people. The side-effects generally start within 24 hours and last around one or two days, and indicate your immune system is working.

In Australia, data from the AusVaxSafety vaccine surveillance system shows about 22% of people vaccinated with the AstraZeneca vaccine missed a day or more of work or studies as they were unwell. Fewer than 2% needed to see a doctor.

What about the blood clots I’ve been hearing about?

Serious reactions to the vaccine have been very rare, one of which includes thrombosis with thrombocytopenia syndrome, which is on everyone’s mind right now.

This is a very rare condition in which blood clots (thrombosis) and low levels of platelets (thrombocytopenia) occur 4-28 days after receiving the vaccine. This can lead to disability and 20-25% of people with these clots die.

About six in every million people vaccinated with the AstraZeneca vaccine develop the condition. And it tends to be more common in people under 50. Other than younger age, there are no other risk factors for these clots we know of yet.

In Australia, there have been six cases of this type of blood clotting: one person in their 30s, four in their 40s, and one in their 80s. Of these, a person in their 40s has died from it.

As Australia is largely COVID-free, is it worth me getting the AstraZeneca vaccine?

The risk-benefit analysis for Australians right now differs depending on the amount of COVID-19 in the community, your age and the availability of alternative vaccines.

Based on a small amount of data so far, the risk of these blood clots after the AstraZeneca vaccine, for people aged 50-59 is about 0.4 per 100,000 and for those aged 60-69, 0.2 per 100,000.

But the risk of getting severe COVID-19 or the risk of admission into intensive care from COVID-19 is much higher for the over 50s — nearly ten-fold higher than the risk of clots after the vaccine.

It’s about 6.5 per 100,000 people aged 50-59 and 7.0 per 100,000 for people aged 60-69, based on data from Victoria’s second wave in July 2020. There are different risk-benefit calculations for different scenarios.

In a scenario similar to the second wave of COVID-19 in Victoria, the risk of ICU admission due to COVID-19 is much higher than the risk of blood clots from the AstraZeneca vaccine.
from the Australian Government Department of Health

Australia has almost no disease in the community. However, this could change very quickly if there were new outbreaks. We also have no alternative to the AstraZeneca vaccine for most people over 50 (more Pfizer vaccine is not available until the last quarter of 2021). So balancing the risks and benefits of the vaccine, is extremely challenging. People may not perceive their risk of COVID-19 as high enough to warrant vaccination and are preferring to wait, perhaps six months or more until other vaccines are available.

However, the potential benefits of the vaccine go far beyond what we’ve already mentioned. Vaccination will contribute to the prevention of long COVID-19 (symptoms that linger for months) as well as increased ability to move around freely in society, including being able to attend large events. Vaccination will help us avoid lockdowns or school closures, allow us to travel overseas and return to normal life.

How do I get vaccinated?

You can use the government’s vaccine eligibility tracker to check whether you can receive your COVID-19 vaccine from today, and to make an appointment.

This will give you details of the state- and territory-run vaccination clinics near you that are open from today (not all are taking appointments for the over 50s yet). From May 17, you can receive your vaccine at some GP clinics.

Two doses of the AstraZeneca vaccine are needed for best protection, preferably 12 weeks apart.

Department of Health/The Conversation, CC BY-ND

Meru Sheel, Epidemiologist | Senior Research Fellow, Australian National University; Cyra Patel, PhD candidate, Australian National University, and Margie Danchin, Paediatrician at the Royal Childrens Hospital and Associate Professor and Clinician Scientist, University of Melbourne and MCRI, Murdoch Children’s Research Institute

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

We don’t yet know how effective COVID vaccines are for people with immune deficiencies. But we know they’re safe — and worthwhile

Posted on March 31, 2021 by particularkev

Vanessa Bryant, Walter and Eliza Hall Institute and Charlotte Slade, Walter and Eliza Hall InstituteThe COVID vaccine rollout is underway in Australia, with people in phase 1b now eligible to be vaccinated.

So far, we have two vaccines available in Australia: the Pfizer/BioNTech vaccine, approved for people aged 16 and older, and the Oxford/AstraZeneca vaccine, approved for those over 18. Evidence has shown both vaccines are safe and offer near-complete protection against severe COVID-19, hospitalisation and, most importantly, COVID-related death.

Both vaccines are also safe and effective at generating immune responses in the elderly. But what about another vulnerable group — people with immunodeficiencies? Many people with immunodeficiencies are included in group 1b and will now be thinking about getting their vaccine.

Although we’re still gathering data to determine whether COVID vaccines will work as well in people with immunodeficiencies as they do in the general population, they’re likely to offer at least a reasonable degree of protection. And importantly, we know they’re safe.

What are immunodeficiencies?

Immunodeficiencies are conditions that weaken the body’s ability to fight infection. People’s immune system may be compromised for many reasons, and this can be transient or lifelong.

Primary immunodeficiencies occur when some or all of a person’s immune system is missing, defective or ineffective. These are rare and often genetic diseases that may be diagnosed early in life, but can occur at any age.

Examples of primary immunodeficiencies include severe combined immunodeficiency (SCID) and common variable immunodeficiency (CVID).

Secondary immunodeficiencies are acquired, and more common. They may occur as a result of other diseases (for example, via HIV infection), treatments and medications (such as chemotherapy or corticosteroids), or environmental exposure to toxins (for example, prolonged exposure to heavy metals or pesticides).

Sometimes the immune system in people with immunodeficiencies can react in exaggerated ways too, and cause autoimmune disease (such as rheumatoid arthritis or gut inflammation). So it sometimes makes more sense to describe the immune system as “dysregulated”, rather than “deficient”.

An illustration of SARS-CoV-2, the virus that causes COVID-19. — People with immunodeficiencies are more susceptible to being infected with viruses, such as SARS-CoV-2.
Shutterstock

Immunodeficiencies, COVID-19 and vaccines

People with secondary immunodeficiencies are generally at higher risk of becoming infected with SARS-CoV-2 and of developing severe disease. Surprisingly, although people with primary immunodeficiency may be at greater risk of getting infections, including COVID, most are no more susceptible to developing severe COVID compared with the overall population.

This may be because the most severe COVID-19 symptoms are usually not due to gaps in immunity, but to an overactive immune response to SARS-CoV-2.

In fact, immune-suppressing steroids may be an effective treatment for severe COVID. Clinical trials looking into this are underway.

However, as vaccines work by mobilising our immune systems, for people who have a weaker immune system to begin with, vaccines may not be as effective. They may generate an incomplete or short-lived response, so people with immunodeficiencies may need additional boosters to maintain protective immunity.

Efficacy and safety

It’s difficult to assess COVID vaccine efficacy in people with immunodeficiencies, because people with primary immunodeficiencies or cancer weren’t included in clinical trials.

A very small number of people with HIV have been included in trials of a few of the vaccines, but limited data is publicly available. So it’s too early to draw any firm conclusions on whether the vaccines will be as effective in people with HIV as for the general population.

We also don’t yet know how long immunity to COVID-19 or COVID vaccines lasts. This will be particularly important for immunodeficient people. Research is underway to determine whether they’ll need booster jabs more frequently to maintain immunity.

A woman wearing a head scarf looks out the window. — Clinical trials of COVID vaccines haven’t generally included people with immunodeficiencies.
Shutterstock

We do know the vaccines are safe for this group.

Neither the AstraZeneca nor the Pfizer vaccines can cause an infection, so they won’t present a problem for people with immunodeficiencies (or for elderly people, who may also have weakened immune responses).

Usually, we avoid giving “live attenuated” vaccines (vaccines that contain weakened elements of the virus) to anyone with immunodeficiency. Because of their weakened immune systems and increased susceptibility to infection, there’s a chance they could develop a full-blown infection. An example of this is the chickenpox vaccine. But no live attenuated COVID vaccines have been approved anywhere in the world.

Preliminary evidence from vaccine rollouts around the world has shown COVID vaccines are safe for immunocompromised people with cancer. Although, if you’re going through cancer treatment, you should discuss the timing of your vaccination with your specialist.

There have been no unusual safety concerns to indicate any increased risk for HIV-positive people receiving any of the COVID vaccines either.

Get the jab

Vaccination is most definitely recommended for people with immunodeficiencies, and they’re included in priority groups for vaccine rollout in Australia. Group 1b includes people with underlying medical conditions which may place them at higher risk from COVID-19, including “immunocompromising conditions”.

If you have a diagnosed immunodeficiency or autoimmune disease, you can talk to your doctor or specialist for specific advice on the timing of your COVID vaccination and your condition. There’s generally no reason to change your normal medications or therapies before receiving the vaccine.

Organisations including the Australian Society of Clinical Immunology and Allergy and the Immune Deficiency Foundation of Australia have published resources which offer guidance for people with immunodeficiencies in relation to COVID vaccination.

Vanessa Bryant, Laboratory Head, Immunology Division, Walter and Eliza Hall Institute and Charlotte Slade, Laboratory Head, Immunology Division, Walter and Eliza Hall Institute

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

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

Posted on March 8, 2021 by particularkev

Nina Jane Chad, University of Sydney and Karleen Gribble, Western Sydney University

From Monday, Australia’s front-line health workers, quarantine staff, border control officers, and workers and residents in aged-care homes will be offered the Pfizer COVID-19 vaccine.

Some of these workers will be women who are pregnant, planning a pregnancy, and/or breastfeeding.

So they may be concerned about whether the vaccine is safe for themselves and their babies.

What issues do these women need to consider?

Remind me again, which vaccine?

Australia’s drug regulator, the Therapeutic Goods Administration (TGA), has approved two vaccines. Pfizer’s vaccine has been approved for people aged 16 years and older; the AstraZeneca vaccine for people aged 18 and older.

Although neither approval excludes women who are pregnant or breastfeeding, the TGA recommends their use in pregnancy be based on an assessment of whether the benefits of vaccination outweigh the potential risks.

The federal health department has issued a decision guide to help women who are pregnant, breastfeeding, or planning pregnancy assess whether the benefits of having the Pfizer vaccine outweigh the risks.

Should I get vaccinated if I’m breastfeeding?

Major health authorities worldwide agree it’s safe to breastfeed after getting a COVID-19 vaccine. The Australian health department says it has no concerns about the safety of the Pfizer vaccine for breastfeeding women or their babies.

Although no studies have specifically investigated whether COVID-19 vaccines get into breastmilk, the baby’s stomach acid would destroy them if they did.

Antibodies against the virus have been detected in the milk of mothers who have been infected with COVID-19. So, if the antibodies the vaccine triggers also pass into breastmilk, getting vaccinated while you’re breastfeeding may even help to protect your baby against COVID-19. Antibodies in breastmilk are widely known to help protect infants against a wide range of infections.

Woman breastfeeding newborn baby — Even if the vaccine passed into your breastmilk, it would be destroyed by the acid in your baby’s stomach.
www.shutterstock.com

How about if I’m pregnant?

The Australian health department is encouraging women who are pregnant and at high risk of catching COVID-19, or who have medical conditions that make them more vulnerable to severe COVID-19 disease, to consider getting vaccinated.

The World Health Organization is even clearer in recommending women who are pregnant to be vaccinated if they are at high risk of catching COVID-19 or of developing severe COVID-19 disease.

While it might seem safer to wait until you’re no longer pregnant to be vaccinated, that may be riskier. Pregnant women are more likely to get severe COVID-19 than other infected women, and are slightly more likely to give birth prematurely if they have COVID-19.

So vaccination is important, especially if you are a front-line health, aged-care, or quarantine worker.

Are the vaccines safe for pregnant women and their babies?

Almost all vaccines are safe during pregnancy and some are recommended to protect women and their babies from infectious disease. Even those that are not generally recommended can be given to pregnant women in certain circumstances, for instance when it would be safer to have the vaccine than to be exposed to infectious disease without the protection vaccination provides.

COVID-19 vaccines cannot cause coronavirus infection because they do not contain the virus that causes it.

The active ingredient in the Pfizer vaccine is mRNA, a tiny fragment of genetic material (messenger ribonucleic acid) that triggers our own cells to produce a spike protein similar to the one on the surface of the coronavirus. This triggers an immune response that destroys the spike protein and teaches our bodies to recognise the virus that causes COVID-19. mRNA is very fragile, so it is destroyed in our bodies very quickly.

While we are still gathering more information about the use of COVID vaccines in women who are pregnant, there are some encouraging signs. About 20,000 pregnant women in the United States alone have been vaccinated and there have been “no red flags” around safety.

What about women in other jobs?

Women who are not working in front-line health, aged care, border protection or hotel quarantine will not be offered COVID-19 vaccination for some time yet.

Fortunately, in Australia it is very unlikely for someone who is not a front-line worker to be exposed to COVID-19 because there are so few cases in the community.

By the time vaccination is offered to healthy women who are not in high-risk occupations, many hundreds of thousands of pregnant women will have been vaccinated worldwide, giving us more information on which to base our recommendations.

So, why the controversy?

Researchers did not include women who were pregnant or breastfeeding in COVID-19 vaccine research. So when the first vaccines were offered to health workers in the United Kingdom, for instance, health authorities did not recommend vaccinating women who were pregnant or breastfeeding.

While this may have been motivated by a desire to protect them, it had the opposite effect. UK women in jobs that placed them at high risk of contracting COVID-19, were left without the protection offered by vaccination. Some women stopped breastfeeding. Others felt it meant choosing between working while unvaccinated and not working at all. Recommendations in the UK have since changed, and pregnant or breastfeeding women in high-risk occupations are now offered vaccination, just as they will be here.

In Australia, the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) says that, although there is no evidence COVID-19 vaccines could cause harm when given to women in pregnancy, there is insufficient evidence to recommend Australian pregnant woman routinely get vaccinated. This recommendation may change if the number of COVID-19 cases increases in Australia.

However, RANZCOG does recommend that women with particular underlying medical conditions discuss the pros and cons with their health-care provider. It also suggests pregnant women working in high-risk environments be offered alternative duties that reduce their chance of exposure to the virus.

So what do we make of all this?

From what we know so far, breastfeeding women can be vaccinated without risk to their babies. And the World Health Organization says vaccination is safer for pregnant women who work in places where they are at high risk of exposure to COVID-19 than not getting vaccinated.

Women who are not working in high-risk occupations, whose risk of exposure is low because community transmission is low, will not be offered vaccination for some time. By the time it’s their turn, health authorities should be able to make clearer recommendations.

Nina Jane Chad, Infant Feeding Consultant, World Health Organization; Research Fellow, University of Sydney School of Public Health, University of Sydney and Karleen Gribble, Adjunct Associate Professor, School of Nursing and Midwifery, Western Sydney University

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

Why we’ll get COVID booster vaccines quickly and how we know they’re safe

Posted on March 7, 2021 by particularkev

Jamie Triccas, University of Sydney and Anthony (Tony) Cunningham, University of Sydney

The United States’ drug regulator, the Food and Drug Administration (FDA), said last week COVID vaccines updated for variants won’t need to go through full randomised controlled clinical trials.

The booster shots will only be required to undergo initial testing to check they are safe and produce an immune response. They won’t need to go through lengthy “phase 3” efficacy trials which would normally enrol tens of thousands of participants.

The European Medicines Agency hasn’t published formal guidelines, but has taken the same position. Chair of the agency’s vaccine evaluation team, Marco Cavaleri, told Reuters: “We will ask for much smaller trials, with a few hundred participants, rather than 30,000 to 40,000”. The focus would be primarily on safety and immune response data.

This is encouraging news, because it means we could get access to booster shots much more quickly than if they went through full trials. And because drug companies will have to prove they’re using the same technology and manufacturing process as the original vaccines, we can still be assured they’ll also be safe.

Australia’s Therapeutic Goods Administration (TGA) has not yet confirmed whether it’ll do the same, but history tells us we can probably expect it to follow suit.

Why do we need boosters?

Variant strains of the virus have been detected around the world, including those originating in the UK, South Africa and Brazil. People infected with these variants have been found in Australian hotel quarantine, and the B.1.1.7 strain, first found in the UK, has escaped the quarantine system several times.

For those tested, the current crop of vaccines still perform relatively well against the B.1.1.7 strain.

And data suggest most COVID vaccines will still be somewhat useful in preventing hospitalisation and death from these variants.

However, efficacy against mild to moderate illness, and against transmission of the virus, has likely dropped off sharply against some of these variants.

For example, preliminary data suggest vaccine efficacy for AstraZeneca’s vaccine dropped to just 10% against mild-moderate illness from the B.1.351 variant which originated in South Africa. Efficacy of Novavax’s shot slid from 89% to 60% against this variant. These data were from small trials and more studies are needed, but it’s still very concerning.

We don’t have solid real world data yet about the performance of the Pfizer vaccine against the B.1.351 variant.

Why don’t we need full trials again?

Drug companies have flagged the need to develop updated booster shots to cover these new variants, which would involve tweaking their sequences.

Some scientists were worried this would mean drug companies would have to go through full randomised controlled clinical trials, including large phase 3 efficacy trials, to get these booster shots to market. These phase 3 clinical trials include many thousands of volunteers and the primary aim is to determine if the vaccine can prevent people from getting the disease.

By the time these trials were completed, it may be too late to control outbreaks caused by variants, and new variants may emerge that we’d need coverage for. In a pandemic, we don’t have the luxury of time.

But the FDA has dispelled this fear. The drug regulator seems most interested in ensuring any booster shots are safe and the manufacturing process hasn’t been modified from the original vaccines it approved.

The boosters will still require smaller trials to show they’re safe and generate an immune response. The trials typically involve a few hundred people and would examine the percentage of vaccinated volunteers who make antibodies to the variants, as well as the strength of the immune response.

This would be similar to what’s done for annual flu shots, although not exactly the same. We get very different flu strains circulating every few years, but current COVID-19 vaccines and variant “boosters” could be sufficient to use for several years — we don’t know yet.

The FDA also indicated boosters won’t necessarily need to undergo animal testing before progressing to human testing, which will also save time. But this may be encouraged if results from human trials are ambiguous.

How do we know they’ll be safe and effective?

Any potential side effects from a vaccine are mostly based on how the vaccine is made, the technology and how it’s delivered.

If drug companies keep all these factors the same, and only make minor sequence changes to cover variants, then we can expect the boosters to still be very safe vaccines.

The US and EU drug regulators would like to see data where the booster is given to people who’ve already had an original COVID vaccine, given this will be the likely scenario for most people receiving a booster shot by the time they’re approved.

The boosters will probably also be tested in people who haven’t had any COVID disease or vaccine. This is to ensure the boosters can induce strong immune responses like the original vaccine.

When required, the TGA will independently review all of this data. It will also likely seek advice from internal and external experts.

It’s also unclear when booster shots will be available or if they will be necessary in the short term. Melbourne-based biotech company CSL, which is producing the AstraZeneca vaccine onshore, said this week booster shots to cover coronavirus variants probably won’t be available until the end of the year.

US pharmaceutical company Moderna has already sent a new COVID vaccine booster shot for phase 1 testing, to target the B.1.351 variant. Pfizer is also planning to develop a booster to cover this variant, either as a third dose or a reformulated vaccine.

New variants will continue to arise, but the best chance we have of stopping or slowing this process is by continuing public health measures to ensure as few people as possible become infected.

This includes vaccinating as many people as possible globally with the currently approved vaccines, which underscores Australia’s responsibility to assist countries in our region in getting vaccinated.

Jamie Triccas, Professor of Medical Microbiology, University of Sydney and Anthony (Tony) Cunningham, Professor, Faculty of Medicine & Health, University of Sydney

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

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

Posted on March 2, 2021 by particularkev

Nicholas Wood, University of Sydney and Kristine Macartney, University of Sydney

With the rollout of COVID-19 vaccines about to begin in Australia, people may be wondering if they’re safe (and effective) in the long term. What might be the health consequences a year after vaccination, or further into the future?

While it’s true COVID-19 vaccines have been developed in record time, the importance of tracking vaccine safety is not new. We routinely monitor the safety of all vaccinations, years after they’ve been used in millions of people.

And in guidance from the Therapeutic Goods Administration (TGA) this week, we have a clearer picture of how we’ll know about any unexpected, rare or long-term side-effects of the COVID-19 vaccines. In fact, we’ll use and build on many existing systems to look out for these.

Vaccine trials only tell us so much

Late-stage vaccine trials in tens of thousands of people only last for a defined period of time, typically 12 months. Vaccine manufacturers present data on vaccine safety (and efficacy) for that time-frame to regulatory bodies. Safety data is rigorously assessed before a vaccine is approved for use.

But when approved vaccines are then given to the general public, we can monitor for any new events that may occur unexpectedly in both the short and longer term. Tracking potential side-effects in the real world in all people who have a vaccine, and outside the tightly controlled conditions of a trial, means we can ensure the vaccine is safe when given to millions — or billions — of people.

So how might this work for COVID-19 vaccines? The Pfizer/BioNTech vaccine phase 3 trial reported safety data until about 14 weeks after the second dose. The Oxford/AstraZeneca trial reported safety data after about three months after the first dose, and two months after the second dose.

However, participants in both these large trials will continue to be followed up for both efficacy and safety until the end of the study from around 12 months after the first dose of vaccine.

COVID vaccine safety is also being monitored in several other ways, by individual countries, including Australia. Countries also share their vaccine safety monitoring data via a global database.

Here’s how we’ll monitor COVID vaccine safety in Australia

The TGA has overall responsibility for monitoring the safety of medicines and vaccines in Australia. Just this week, the TGA released its plans for monitoring the safety of COVID-19 vaccines.

This includes the timely collection and management of reports of COVID-19 vaccine adverse events, an ability to urgently detect any safety concerns and to communicate safety issues to the public.

‘Passive’ surveillance

A cornerstone of the system Australia has had in place for decades to capture any possible vaccine reactions is “passive” surveillance. In practice, this means anyone can report a reaction to the TGA, the public included.

If your GP or nurse thinks you may have had a reaction they should report this to their state or territory health department, which then informs the TGA. This is mandatory in some jurisdictions but not in others.

Woman holding smartphone about to make a call — Consumers are being encouraged to report any suspected side-effects after their COVID vaccine.
www.shutterstock.com

The TGA is encouraging health professionals and consumers to report suspected side-effects to COVID-19 vaccines and there is a guide on its website on how to do this.

The TGA has a database that records any reported possible reactions. If there are any suspected safety issues, these are immediately investigated and necessary action is taken. For example, if necessary an immunisation program can be stopped or special precautions implemented. TGA can also issue safety alerts.

‘Active’ surveillance

Since 2014, Australia has also been actively looking for any safety concerns via the AusVaxSafety surveillance system, led by the National Centre for Immunisation Research and Surveillance, which we are affiliated with.

We send texts or emails to people asking them to fill out a survey on their health after being vaccinated. This system enables us to detect any suspected safety issues in near real time. Last year, AusVaxSafety surveyed nearly 290,000 people after they had the 2020 influenza vaccine and found more than 94% felt completely well. Others had mild and expected short-term side effects.

This system will be used to pick up any safety concerns when the COVID-19 vaccines roll out in the next few weeks. If you are vaccinated at selected sites, including GP practices and COVID-19 vaccine hubs, you will be told about this automated system. You don’t have to register or enrol but will be sent an SMS on day 3 and day 8 after each vaccine dose (you can decide whether to fill out the survey). Your anonymised results will be reported to your state or territory health department and the TGA.

This system will probably be in place to monitor safety of the COVID-19 vaccines for a few years. And as new vaccine brands come on board, we will continue to monitor those too.

We can also learn from other countries

The United States has recently developed an equivalent system, V-safe. Safety data from this system from about two million people who have had a COVID-19 vaccine indicates the vaccines are safe. The short-term side-effects are very similar to those reported in the vaccine trials. The most common reactions include injection site pain, headache, tiredness and muscle aches, usually in the first two days and then resolving within a week after vaccination.

And worldwide, more than 150 million COVID-19 vaccine doses have already been given, with no unexpected safety concerns.

In a nutshell

The potential benefits to us all from a mass vaccination program against COVID-19 far outweigh the potential side-effects, based on data from millions of people who have already been vaccinated around the world. Yet, we know all medicines, vaccines included, have the potential for side-effects.

However, by using, and building on, our already established safety surveillance system, we will be “on top” of rapidly identifying any possible safety concerns. That’s immediately after vaccination and into the longer term.

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.

Sharing my thoughts with the world from a Particular Baptist perspective

Remind me, what is Worksafe?

Why did Worksafe charge the health department?

Is it unusual for a government regulator to fine a government department?

What does this mean for other employers?

What happens next for the Vic health department?

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Level 1: vaccination and working from home

Level 2: safe indoor air

Level 3: administrative measures

Level 4: masks

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Who is most vulnerable to serious disease?

What have we learnt from other countries?

What’s happening in Australia?

Who is getting vaccinated?

No targets yet for vaccinating vulnerable groups

What can be done?

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1. Vaccinate the adults around them

2. Mandate masks for teachers and students

3. Ventilated classrooms

4. Reduce numbers of people indoors

5. Test school kids

What about childcare centres?

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How does Sputnik V work?

How well does Sputnik V work against COVID-19?

What are the unanswered questions about Sputnik V?

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Does the AstraZeneca vaccine protect people over 50?

How safe is the AstraZeneca vaccine in people over 50?

What about the blood clots I’ve been hearing about?

As Australia is largely COVID-free, is it worth me getting the AstraZeneca vaccine?

How do I get vaccinated?

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What are immunodeficiencies?

Immunodeficiencies, COVID-19 and vaccines

Efficacy and safety

Get the jab

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Remind me again, which vaccine?

Should I get vaccinated if I’m breastfeeding?

How about if I’m pregnant?

Are the vaccines safe for pregnant women and their babies?

What about women in other jobs?

So, why the controversy?

So what do we make of all this?

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Why do we need boosters?

Why don’t we need full trials again?

How do we know they’ll be safe and effective?

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Vaccine trials only tell us so much

Here’s how we’ll monitor COVID vaccine safety in Australia

We can also learn from other countries

In a nutshell

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