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Covid-19 News Updates


Western Australia reimposes home quarantine for Queensland arrivals

Western Australia reimposes home quarantine for Queensland arrivals

Travellers form Queensland into Western Australia will now need to quarantine for two weeks at home as ‘low risk’ border restrictions are reimposed on the Sunshine State.

It comes as QLD opens its borders to travellers from the entire country today, provided they are fully vaccinated and have had a negative COVID-19 result in the 72 hours prior to travel.

Based on the latest health advice, WA has transitioned QLD from a ‘very low risk’ jurisdiction to a ‘low risk’ jurisdiction, which permits travel subject to the following strict conditions:

  • provide proof of being double dose vaccinated against COVID-19 (if eligible)
  • present for a COVID-19 test on arrival (within 48 hours) and on day 12
  • self-quarantine for 14 days in a suitable premises
  • complete a G2G Pass declaration prior to arrival, stipulating they do not have any COVID-19 symptoms and which jurisdictions they have been in the previous 14 days
  • land arrivals to be met at the border checkpoint for a health screening and to have their G2G Pass checked before proceeding to their self-quarantine.  

“Anyone who arrived in WA between Wednesday 1 December and 12:01am, Monday 13 December, and has been at the listed Queensland exposure sites at the specified times between Wednesday 1 December and 12:01am, Monday 13 December, is required to self-quarantine for 14 days and be tested immediately (within 48 hours) and at day 12,” the Western Australian government said.

“Recent arrivals into WA from Queensland who have not been to any exposure sites are advised to get tested if they develop any symptoms that may be related to COVID-19.”

The move from WA comes after QLD eased its border restrictions overnight, following the state achieving 80 per cent of the eligible population fully vaccinated.

As of 1am this morning, the state reopened to travellers from hotspots in New South Wales, the Australian Capital Territory and Victoria.

Travel into the state is conditional on being fully vaccinated, receipt of a negative COVID-19 PCR test taken within the 72 hours prior to arrival into QLD, and agreeing to get another COVID test on day five following arrival.

For those who have not been in a hotspot in the last 14 days, there are no restrictions on entry into QLD.

Updated at 10.03am AEDT on 13 December 2021.

Booster shots now available sooner for fully vaccinated, Moderna gets ATAGI approval

Booster shots now available sooner for fully vaccinated, Moderna gets ATAGI approval

The emergence of new COVID-19 variant Omicron has seen advice from the nation’s vaccine advisory group on the timing of booster shots change as it hands down a recommendation that Moderna’s jab can be used as a third immunisation.

The Australian Technical Advisory Group on Immunisation (ATAGI) now recommends COVID-19 booster vaccination for anyone aged 18 and older who completed their primary course five or more months ago.

This change is down from a previous recommendation of six months after the second shot, and comes in light of the new variant of COVID-19 called Omicron.

“Evidence is still incomplete on the transmissibility, capacity to cause severe disease and overall impact of the Omicron variant. While data suggest that past infection with an earlier variant does not provide significant protection against infection, it remains unclear whether prior infection may reduce severity,” ATAGI said.

“Early data suggest that the protection provided by COVID-19 vaccination against infections with the Omicron variant is impaired compared to those with the Delta variant, but further data are required on the effectiveness against severe disease.

“Preliminary data suggest that the increased antibody levels generated following a COVID-19 vaccine booster dose may offer improved protection against the Omicron variant. However, the correlation between antibody levels in laboratory studies and protection against infection and severe disease is not yet established.”

With Moderna now recommended by ATAGI as a booster shot and provisional approval for the jab given by the Therapeutic Goods Administration (TGA) last week, Australians can choose between receiving a Pfizer (Comiranty) Moderna’s Spikevax shot as a booster.

ATAGI considers the Moderna and Pfizer COVID-19 vaccines to be “equally acceptable” as booster shots for those aged 18 and older, including pregnant women.

“Both mRNA COVID-19 vaccines are preferred over the AstraZeneca COVID-19 vaccine for the booster dose, including for people who received the AstraZeneca vaccine for their primary course,” ATAGI said.

“The AstraZeneca vaccine is not yet TGA approved as a booster but can be used as a booster for people who have contraindications to mRNA COVID-19 vaccines or who had AstraZeneca for their primary course.”

The body also said the weight of evidence suggests that booster shots increase antibody levels substantially, likely offering protection against both Delta and the new Omicron variant.

“The anticipated benefits of bringing forward the booster dose include earlier protection, particularly against severe disease in those at risk, and improved protection against COVID-19 due to the Omicron variant,” ATAGI said.

“Vaccine manufacturers have also signalled they are examining the need for and potential development of COVID-19 vaccines that may be more effective against new variants, however this is expected to take several months.”

Updated at 9am AEDT on 13 December 2021.

Moderna booster shot receives provisional approval from TGA

Moderna booster shot receives provisional approval from TGA

The Therapeutic Goods Administration (TGA) has today provisionally approved the use of Moderna’s COVID-19 vaccine called SPIKEVAX for individuals 18 years and older in Australia.

The decision means those eligible may receive Moderna’s shot as a booster (third dose) at least six months after their second jab as long as the Australian Technical Advisory Group on Immunisation (ATAGI) also gives it the green light.

According to the TGA, the first two vaccines received can be any of the other COVID-19 vaccines registered for use in Australia, noting the data on the use of SPIKEVAX as a booster with other brands like Pfizer or AstraZeneca is more limited.

The TGA also advises that severely immunocompromised people aged 12 years and over can received their third primary dose of a COVID-19 vaccine at least 28 days after the second dose.

“TGA provisionally approved the booster dose following careful evaluation of the available data supporting safety and efficacy,” says the TGA.

“The TGA's decision was also informed by expert advice from the Advisory Committee on Vaccines, an independent committee with scientific, clinical and consumer representation.”

Federal Minister for Health Greg Hunt noted the significance of the announcement, acknowledging ATAGI is yet to make its decision.

“In addition to the Pfizer booster, subject to final approval - a second green-light by ATAGI…Australians will have two options for boosters very shortly,” Hunt said.

“I think this is another important step. Every day we’re making new strides and new progress with the vaccine program.”

Pfizer provisionally approved for kids

Today's announcement from the TGA comes three days after the Administration provisionally approved the use of Pfizer's COVID-19 vaccine called COMIRANTY in children aged 5 years and older.

Like other age groups, the TGA says the use of this vaccine in children aged 5-11 years should be given in two doses at least three weeks apart. However, a lower dose (10 micrograms) will be given to children aged 5-11 years, compared to that used for individuals 12 years of age and older (30 micrograms).

The provisional approval was made following consideration of data from clinical trials conducted in the United States, Finland, Poland and Spain, which demonstrated effectiveness by showing that the immune response to the vaccine in children was similar to that seen in older people.

Clinical trials also showed that the safety profile in children is similar to that seen in adults with the observed side effects being mild. The most frequent adverse events seen in clinical trials in children aged 5-11 years were injection site pain, fatigue, headache, injection site redness and swelling, muscle pain and chills.

Further advice on the rollout of COMIRNATY to this age group will be provided to Government by ATAGI.

Updated at 3.48pm AEDT on 8 December 2021.

QLD Premier confirms borders to reopen four days early

QLD Premier confirms borders to reopen four days early

With Queensland health authorities expecting the 80 per cent double-shot vaccination target to be reached this week, Premier Annastacia Palaszczuk has announced an earlier border reopening for next Monday.

"I'm very conscious that we want to give people certainty - we want to give families certainty and business certainty, but also too, it's a big administrative function now that government has to do, police need time to set up, and we just want to make sure everything is in order," the Premier said this afternoon.

"To provide everyone with that certainty I can advise that we will be bringing forward the opening date of our borders from December 17 to 1am, Monday, December 13."

This includes a reopening to the hotspots of NSW, VIC and ACT.

"Fully vaccinated travellers from interstate hotspots can arrive by road or air," she said, although there are expectations for delays at the border.

"You must have a negative COVID test in the previous 72 hours, so please, you've got this date now so you can go and start organising that test, and no quarantine is required if you are fully vaccinated.

"If you are not fully vaccinated you must arrive by air only, and hotel quarantine for 14 days."

The Queensland Government has also changed its definition of what constitutes 'fully vaccinated', from the previous limit of at least two weeks since the second shot, to one week as per the national guidelines.

All arrivals from domestic hotspots must also get a second COVID test on day five when they get to Queensland.

The Premier acknowledged how tough the restrictions have been on border communities, whose residents she said would be able to move across the border freely as of next Monday provided they have a border pass which needs to be renewed every 14 days.

Updated at 3:19pm AEDT on 6 December 2021.

Will Australia follow Europe into a fourth COVID wave?

Will Australia follow Europe into a fourth COVID wave?

Europe is facing a fourth wave of COVID. As we watch on, it is reasonable to ask whether Australia will be confronted with the same fate.

Several factors will determine this: vaccination rates, high uptake of third dose boosters, vaccination of children and whether a comprehensive strategy of ventilation with vaccine-plus measures including masks, testing and tracing are used.

New OzSAGE modelling for NSW shows possible increasing cases from mid-December with a predicted peak in February 2022, despite high vaccination rates. OzSAGE warns if contact tracing is not maintained and children 5–11 remain unvaccinated, hospitals may be overwhelmed again. But if we vaccinate young kids and maintain high testing and tracing, the outlook is good.

If not for Delta …

If the ancestral strains of the virus that dominated infections in 2020 were still in pole position, we would now have COVID well controlled in countries that achieved higher than 70% of the whole population vaccinated.

Unfortunately, just as the vaccines became available, new variants of concern began emerging. The currently dominant Delta variant raises the stakes because it is far more contagious and has some potential to escape the protection offered by vaccines. This means we need very high rates of vaccination across whole populations – probably over 90% of everyone vaccinated including younger children – to control the virus.

In addition, we need to start thinking about “fully vaccinated” being triple, not double, vaccinated.

covid cases by country graph
World in Data, CC BY

Boosters are key

Patchy third dose booster policies in Europe may partially be to blame for the COVID surges we are seeing in countries there now.

Germany, for example, in October recommended boosters for people 70 years and over and certain risk groups. On November 18, it belatedly changed the recommendation to people aged 18 years and over in response to the large resurgence of COVID.

France, too, has been slow and restrictive in making boosters available for adults, with people over 50 eligible from this December. Likewise, Ireland only approved boosters for people 60 years and over at the end of October.

The evidence is clear that boosters are needed. So, on the background of inadequate vaccination rates ranging from 64% in Austria to 76% in Denmark, a slow and restrictive approach to boosters, together with abandoning other measures such as masks, has left many European countries vulnerable.

Austria, with one of the lowest vaccination rates, has one of the highest rates of COVID, prompting it to be the first European country to mandate vaccines.

Much of the fourth wave is also being driven by transmission in children. The EU has been slow to approve vaccines for younger children, prompting Austria to commence vaccinating children without EU approval.

vaccination by country graph
World in Data, CC BY

Too much reliance on vaccines?

The fourth wave follows the relaxation of COVID restrictions like masks, density limits, testing and tracing; and failure to address safe indoor air.

The Delta virus is a tenacious beast, and the vaccine alone is not enough to tame it. Country after country has shown this, including Denmark, which ceased all restrictions, including masks in September and is now facing a large surge in cases despite relatively high vaccination rates.

The prospect of a fourth wave also depends on the epidemiology of SARS-CoV-2. There is a high probability new variants will emerge that will challenge us further, either because they are even more contagious or more vaccine-resistant.

That said, we have seen spectacular advances in science, with vaccines produced in less than a year. There are many more second generation vaccines and matched boosters in the pipeline, and promising new antivirals for early treatment. So our ability to fight this virus will keep improving.

What about Australia then?

So will Australia also face a fourth wave? Yes, it’s likely because SARS-CoV-2 is an epidemic infection. It will continue to cause the waxing and waning cycles of true epidemic infections just like smallpox did for thousands of years, and like measles still does. However, it’s possible we can achieve elimination of COVID just as we have with measles, and only see small outbreaks.

patterns of disease graph
Author provided

If we’re successful, outbreaks may still occur – but they will not become sustained or uncontrollable. Here’s what Australia can learn from Europe and other countries:

  • firstly, we need to aim for at least 90% of the whole population vaccinated – this should be done equitably for all states and territories, for remote and regional areas and for all subgroups including children

  • we need to be agile and responsive to evidence, including the need for subsequent boosters. If a new vaccine or Delta-matched booster comes along that improves protection, we need to add that to the tool box rapidly

  • childcare and schools are fast becoming the new frontier of COVID. We must ensure safe indoor air, masks and vaccination for younger children by the time students return from summer holidays in 2022

  • vaccines alone are not enough, so let’s not be like Denmark and embark on magical thinking. We need to address safe indoor air and have a vaccine-plus strategy. That means masks in indoor settings, maintaining high testing and tracing levels, protecting younger kids until they are eligible for vaccination and ensuring high uptake of boosters.

If we acknowledge the airborne transmission of COVID and adopt effective ways of preventing this virus, we can defeat it.

But that requires a layered, comprehensive strategy of ventilation, vaccine-plus measures and the ability to move quickly with evidence as it becomes available.

New vaccines and new ways of employing them are hopefully on their way. Until they eventuate, we’ll need to be ambitious in our COVID strategy and keep using ventilation, masks and other measures to avoid a severe fourth wave.The Conversation

C Raina MacIntyre, Professor of Global Biosecurity, NHMRC Principal Research Fellow, Head, Biosecurity Program, Kirby Institute, UNSW

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

International students, skilled workers welcome next month, travel bubble extends to Japan and Korea

International students, skilled workers welcome next month, travel bubble extends to Japan and Korea

Fully vaccinated students, skilled workers, working holiday makers, overseas family members and refugees will be allowed to enter Australia without needing to receive a travel exemption from 1 December as part of the Federal Government’s reopening plan, provided they have the appropriate visas.

In addition, fully vaccinated citizens from Japan and South Korea will be permitted to travel from their home country quarantine-free to some states and territories without needing to seek a travel exemption from the beginning of December too.

As announced today by Prime Minister Scott Morrison, fully vaccinated eligible visa holders can come to Australia from 1 December without needing to apply for a travel exemption. Eligible visa holders include skilled and student cohorts, as well as humanitarian, working holiday maker and provisional family visa holders.

Under these arrangements, travellers must:

  • Be fully vaccinated with a completed dosage of a vaccine approved or recognised by Australia’s Therapeutic Goods Administration (TGA)
  • Hold a valid visa for one of the eligible visa subclasses
  • Provide proof of their vaccination status
  • Present a negative COVID-19 Polymerase Chain Reaction (PCR) test taken within three days of departure.

Travellers to Australia must comply with the quarantine requirements in the state or territory of their arrival, and any other state or territory to which they plan to travel.

So far, this includes New South Wales for fully vaccinated people and Victoria which today announced students can arrive in Melbourne without having to quarantine provided they have received two doses of a TGA-approved COVID-19 vaccine.

Under the new arrangements, the Prime Minister also confirmed fully vaccinated citizens of Japan and South Korea who hold a valid Australian visas will be able to travel from their home country quarantine-free to participating states and territories, without needing to seek a travel exemption.

Under these arrangements, travellers must:

  • Depart from their home country
  • Be fully vaccinated with a completed dosage of a vaccine approved or recognised by the TGA  Hold a valid Australian visa
  • Provide proof of their vaccination status
  • Present a negative COVID-19 PCR test taken within three days of departure.

Today’s announcement follows earlier changes which have seen Australia welcome home fully vaccinated citizens, permanent residents and their immediate family members since 1 November, and follows the commencement of the Singapore safe travel zone yesterday.

"The return of skilled workers and students to Australia is a major milestone in our pathway back,” PM Morrison said.

“It’s a major milestone about what Australians have been able to achieve. It will mean a lot for the economies of country, right around the country, who need these workers and want to see those students return.”

Updated at 12.13pm AEDT on 22 November 2021.

Victoria to lift venue and visitor caps tonight with 90 per cent full vaccination milestone in sight

Victoria to lift venue and visitor caps tonight with 90 per cent full vaccination milestone in sight

“Whether it’s 100,000 people at the MCG on Boxing Day, or a smaller group of people standing up at the public bar at the local pub having a beer, this is the COVID normal that every Victorian has built,” Victorian Premier Daniel Andrews said.

After enduring lockdown after lockdown and some of the tightest COVID-19 restrictions in the country, Victorians will return to a greater sense of normality from tonight as the state government eases most of the remaining pandemic rules.

With the Victorian population inching closer to being 90 per cent fully vaccinated - a milestone expected to be reached this weekend - visitor and venue capacity limits will be removed from 11.59pm tonight.

This means capacity limits in clubs, bars, cafes, restaurants and every other public place will no longer be governed by COVID-19 - rather they will revert back to regular liquor licensing laws.

All indoor and outdoor events with less than 30,000 fully vaccinated attendees will be able to proceed with no special approval and outdoor events with 30,000 or more will only need to publish their COVIDSafe Plan.

Indoor venues – including stadiums that have a capacity of 30,000 or more – will need to get a one-off approval of their COVIDSafe Plan from the Victorian Government.

Further, there will no longer be any caps on the amount of people permitted to gather at homes, which is encouraging news for large families as the Christmas period approaches and the weather gets warmer.

In addition, dance floors will reopen to revellers and Victorians will be able to enjoy a drink while standing - simple pleasures that residents have missed out on for large parts of 2020 and 2021.

Masks will also be able to come off in most settings except for retail. However, the Premier said his government was looking to remove mask requirements for shoppers in the middle of December.

However, they will still be required for primary school staff and visitors and for students in Years 3 to 6, for workers serving the public at hospitality venues, for workers and customers at indoor retail, for visitors and select workers in hospitals or care facilities, and for people using public transport, taxi/rideshare and planes.

Non-essential retail settings across Victoria will join the vaccinated economy and will only be open to those who are fully vaccinated, under 12 years and two months, or have a valid exemption.

Quarantine and isolation requirements are also going to change at midnight, meaning close contacts of confirmed COVID-19 cases will no longer have to self-quarantine.

Instead, only confirmed cases will need to isolate, and those that come into contact with infected people just need to get tested and isolate until a negative result is received.

The Department of Health will continue to manage emerging outbreaks of concern and ‘superspreader events’ and can impose a quarantine period on contacts on a case-by-case basis, depending on evidence.

The changes also effectively mean the end of mandatory deep cleaning. Businesses will self-manage their exposure in line with public health guidance. 

“This is quite an amazing achievement on behalf of every single Victorian. Our state should be proud,” Andrews said.

“It really will be a Christmas like no other - but a normal Christmas. It’s one that we’ve all earned. It’s one that every Victorian will enjoy.

“These two years have been so, so challenging and Victorians have given so much. I’m proud of them. I’m grateful to them.”

Updated at 10.55am AEDT on 18 November 2021.

SA to reopen borders on 23 November, unveils new rules for the fully vaccinated

SA to reopen borders on 23 November, unveils new rules for the fully vaccinated

Premier Steven Marshall has announced today that fully vaccinated South Australians will only need to undertake a quarantine period of seven days if they are identified as a close contact of a COVID-19 case, under new rules when state borders reopen on 23 November.

However, the Premier noted those who are unvaccinated still will be required to complete the full 14 days of quarantine if they are found to be a close contact in an exposure site.

From next Tuesday, SA will welcome fully vaccinated travellers from New South Wales, Victoria and the ACT. Travellers from Queensland, WA and Tasmania are already permitted to travel into the state. 

The Premier expects that 80 per cent of South Australians aged 16 and over will be fully vaccinated by 23 November.

“We've always said we wanted to give certainty and clarity. So, we will be lifting those borders on [23 November]. I expect that we will be at that 80 per cent,” he said.

“We're trying to have a more bespoke, tailored approach away from the approach that we had previously which was very heavy handed where everybody who was a close or casual contact needed to go into quarantine.” 

In the next phase, businesses will no longer need to close down for deep cleaning following exposure in their site, as the type of cleaning required will be reduced to what the Premier describes as “a significantly lower level.”

The Communicable Diseases Control branch will be tasked with risk assessment on outbreaks and provide advice to individuals and businesses about the people who will need to go into isolation.

As part of SA's COVID-ready plan, the state has made 392 extra beds and treatment spaces available and have recruited up to 1,920 doctors, nurses, ambulance officers and health staff.

No changes to public health and social measures will be made in SA until 90 per cent of South Australians aged 16 and over are fully vaccinated.

The second-dose vaccination rate in SA currently stands at 73.9 per cent.

“Achieving high vaccination rates is a key part of our strong plan to be COVID-ready and South Australia’s pandemic control going forward,” said the Premier

Not only will it reduce time in quarantine, it is the best way for people to protect themselves, their loved ones and the community from this nasty disease.”

Updated at 05.03pm AEDT on 15 November 2021.

Midweek dining boosted in Melbourne with $5m vouchers, VIC turns up volume for live music support

Midweek dining boosted in Melbourne with $5m vouchers, VIC turns up volume for live music support

The Melbourne Money dining scheme has returned to the city’s cafes, bars and restaurants, with $5 million allocated to encourage visitors to keep the city buzzing beyond the weekend.

Diners in the city will now be able to claim 30 per cent off their bill when they spend between $50 and $500 from Monday through Thursday.

The first round of the initiative in May saw $40 million poured into hospitality businesses, with foot traffic bouncing back three times faster than previous lockdowns.

“The first round of Melbourne Money was such a huge success that we had to come back for seconds,” Lord Mayor Sally Capp said.

“When the city last enjoyed a long stretch of freedom, weekday pedestrian activity still lagged at some 60 per cent of pre-COVID-19 levels, while activity on weekends was as high as 85 per cent.”

To claim the rebate, diners must pay for the meal in full and take a photo of an itemised receipt with the business name and ABN on it.

The photo can be uploaded on the Melbourne Money website and users will be prompted to provide contact and bank details.

Once approved, the rebate is accredited to the nominated Australian bank account within five business days.

“Please take advantage of the rebate and support the great options in the City of Melbourne by coming in for a midweek meal,” said Grossi Restaurants co-owner Liz Rodriguez.

The scheme is being offered through the $200 million Melbourne City Revitalisation Fund – a joint partnership with the Victorian Government.

It is available across the entire municipality including Southbank, Chinatown, Lygon Street, Docklands, North Melbourne and Kensington and at hospitality venues within sporting, arts and theatre precincts.

It will continue until the $5 million funding is exhausted.

Victoria’s live music industry to receive $20 million shot in the arm

Minister for Creative Industries Danny Pearson has announced a $20 million Live Music Restart package that will support the return of live music to the state.

Music venues will receive $8 million to recruit and train new staff, invest in COVIDSafe infrastructure and get more musicians and industry professionals back in the sector.

Meanwhile, music events and festivals will also get an $8 million boost to help them recover from the uncertainty and impact of rescheduled and cancelled events.

The final $4 million will be used to bring music performances to the heart of the city, complementing the $5 million already in place for regional and outer-suburban events.

An Australian-first COVID-19 event insurance product will give event organisers a safety net to plan and stage future shows.

The 12-month scheme, subsidised by the Government and delivered through the Victorian Managed Insurance Authority (VMIA) will ensure up to $230 million of events against cancellation due to public health measures, or where events have reduced capacity due to restrictions.

Funding will be made available through Creative Victoria, with application details to be announced soon.

Updated at 10.36am AEDT on 15 November 2021.

2 million Ellume COVID-19 home tests recalled in the US

2 million Ellume COVID-19 home tests recalled in the US

The United States Food and Drug Administration (FDA) has classified a voluntary recall of 2 million COVID-19 home tests manufactured by Brisbane-based Ellume that were delivering ‘false positive’ results as a ‘Class 1 recall’ - the most serious type of recall it can issue.

“The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur,” the FDA said.

The recall comes after the FDA issued an alert earlier this week, notifying test users, caregivers and health care personnel about the potential for false positive results with certain lots of the Ellume-manufactured test, resulting from a manufacturing issue.

The manufacturing problem meant some people were receiving false positive results - indicating that a person has COVID-19 when they do not actually have it. Negative results were not affected by the manufacturing issue.

In a statement on the Ellume website, the company says it has isolated the cause and confirmed this incidence of false positives is limited to specific lots.

“We worked with the Food and Drug Administration (FDA) to voluntarily remove affected Ellume tests from the market. Importantly, the reliability of negative results is unaffected by this issue and are not included within this recall,” Ellume said.

“At Ellume, we remain committed to developing high-quality digital diagnostics that empower our users to manage their health. Patient well-being and product quality are our first priorities throughout every step of the manufacturing and supply chain process. We understand you are counting on us to do nothing less.

“We offer our sincere apologies for the stress or difficulties people may have experienced due to a false positive result. We have and will continue to work diligently to ensure test accuracy, in all cases.”

The news comes 11 months after the FDA issued an Emergency Use Authorisation to permit the use of the Ellume COVID-19 test in the US.

Test users have been told to compare the lot number on the test carton to the lot numbers on Ellume’s website.

Ellume CEO Dr Sean Parsons has also issued a statement and an apology, noting that the recall may have “shaken the confidence of some of those who trusted Ellume to help them manage their health and to take back a bit of control of their lives during this pandemic”.

“To those individuals, I offer my sincere apologies – and the apologies of our entire company – for any stress or difficulties they may have experienced because of a false positive result,” Dr Parsons said.

“You have my personal commitment that we have learned from this experience, we have implemented additional controls to ensure our product meets our high quality standards and we are going to do everything in our power to regain your trust.”

Updated at 9.20am AEDT on 11 November 2021.

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