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Covid-19 News Updates


CSL shares slip after dumping plans for new COVID-19 vaccine

CSL shares slip after dumping plans for new COVID-19 vaccine

Australia's largest biotechnology company CSL (ASX: CSL) has abandoned its collaboration with the University of Queensland to develop a promising COVID-19 vaccine after discovering it gives a false positive diagnosis for HIV.

While the move does not impact CSL's leading role in the fight against COVID-19 nationally, it wipes out 10 months' work by scientist from both camps to develop their own vaccine.

While CSL says the decision will not impact the company's FY21 profit guidance, shares in the company opened more than 2 per cent lower today.

The vaccine had proven effective during Phase 1 trials conducted in July without any serious adverse effects or safety concerns reported among the 216 participants in the trial. CSL says the vaccine had a robust response towards the virus.

However, tests were abandoned when it was discovered they gave participants a false diagnosis of HIV.

The CSL vaccine produced antibodies that were directed towards the "molecular clamp" component of the vaccine which caused the false HIV readings in some tests.

Follow-up testing showed HIV was not present in those trial participants and that the vaccine itself did not cause HIV.

"This outcome highlights the risk of failure associated with early vaccine development, and the rigorous assessment involved in making decisions as to what discoveries advance," says CSL's chief scientific officer Dr Andrew Nash.

"This project has only been made possible by the innovative science developed by world-class scientists at The University of Queensland and the strong collaboration between our organisations, and many others, over the last 10 months."

Nash says CSL through its Seqirus flu vaccine subsidiary it will continue its efforts to fight COVID-19 through other previously announced relationships, including its deal to produce the Oxford/AstraZeneca vaccine.

"Manufacture of approximately 30 million doses of the Oxford/AstraZeneca vaccine candidate is under way, with first doses planned for release to Australia early next year," Nash says.

"In addition, CSL has agreed at the request of the Australian Government to manufacture an additional 20 million doses."

A successful outcome from the UQ trials would have led to the large-scale manufacture of this additional vaccine.

While it is possible to re-engineer the vaccine, UQ vaccine co-lead Professor Paul Young says time is not on their side.

"Doing so would set back development by another 12 or so months, and while this is tough decision to take, the urgent need for a vaccine has to be everyone's priority," he says.

"I said at the start of vaccine development that there are no guarantees, but what is really encouraging is that the core technology approach we used has passed the major clinical test.

"It is a safe and well-tolerated vaccine, producing the strong virus neutralising effect that we were hoping to see."

Young says the team plans to undertake further work on the "molecular clamp" technology as a pathway to vaccines for future biosecurity threats.

Updated at 10.25am AEDT on 11 December 2020.

Queensland border reopening to New Zealanders from tomorrow

Queensland border reopening to New Zealanders from tomorrow

From 1am tomorrow, Saturday 12 December, Queensland's border will reopen to New Zealand, reuniting families in time for Christmas.

Queensland Premier Annastacia Palaszczuk made the announcement this morning on Nine's Today show, and said the decision was made following health advice.

"Visitors coming in from New Zealand from 1am tomorrow are welcome into Queensland ... and we are hoping that eventually New Zealand will not have to do that hotel quarantine upon return, and then there would be free-flowing movement between the two," she said.

"[Chief Health Officer] Dr Young advised me yesterday that she was more than happy to allow New Zealanders to come into Queensland," she told the Today show.

"It is a wonderful time of year to allow that to happen as well. All the stars are aligned at the moment."

 

 

The announcement comes a day after the state announced further easing of COVID-19 restrictions.

Because Queensland has gone 86 days without community transmission dancing indoors will be allowed at Queensland pubs, clubs, nightclubs and other venues from 12 noon on Monday 14 December.

Three new cases of COVID-19 were detected in Queensland yesterday, all returned overseas travellers in hotel quarantine.

Updated at 9.37am AEDT on 11 December 2020.

Starpharma surges as COVID nasal spray wafts into Europe

Starpharma surges as COVID nasal spray wafts into Europe

Shares in Starpharma (ASX: SPL) surged more than 17 per cent in morning trade after the company announced it was on track to bring its anti-COVID nasal spray to the market earlier than expected.

With an EU regulatory dossier 90 per cent complete, Starpharma says the product, to be marketed as VIRALEZE, will be ready to hit the shelves in the first quarter of next year.

VIRALEZE has been shown to inactivate more than 99.9 per cent of SARS-CoV-2, the virus that causes COVID-19. It is also effective against other respiratory viruses such as influenza.

Starpharma says marketing of the product is well advanced and it is building inventory of components and raw material to support rapid roll-out. The company is preparing to launch in Europe as early as January.

While the upcoming registration approval is restricted to Europe, Starpharma plans to leverage off this to extend the roll-out into other markets including Australia.

The news sent Starpharma shares as high as $1.53 in early trading on the ASX today, up from yesterday's close of $1.30.

Starpharma CEO Dr Jackie Fairley says VIRALEZE has shown it can restore confidence and encourage people to resume daily work and leisure activities.

"Our market research also shows that the compelling features and convenience of VIRALEZE are highly appealing to consumers," she says.

"Even after a vaccine becomes widely available, social distancing, PPE and other measures will continue to be important and VIRALEZE complements other prevention strategies, including vaccines."

VIRALEZE is expected to be used in conjunction with other preventative measures such as COVID-19 vaccines to further reduce the risk of infection.

The World Health Organisation estimated in November that Europe's death rate from COVID-19 is tracking at one person every 17 seconds.

"It is with the greatest urgency that Starpharma is working to make this product ready for market as quickly as possible in 1Q CY21," says Fairley.

Starpharma research shows 60 per cent of people surveyed liked VIRALEZE, with 80 per cent of millennials showing intent to purchase.

Updated at 12.55pm AEDT on 10 December.

Restrictions to ease as SA reports no active cases

Restrictions to ease as SA reports no active cases

With no active cases of COVID-19 in South Australia as of today, a number of COVID-19 restrictions will be eased from next Monday 14 December.

The easing of restrictions will benefit hospitality operators, gyms owners and entertainment facilities, and will enable full family gatherings for the Christmas holiday period.

As such, from Monday 14 December the following restrictions will ease:

  • Standing up while drinking at bars will be permitted
  • Play gyms will be allowed to reopen
  • Capacity limits on home gatherings will increase from 10 to 50 people
  • Private functions will be able to see 200 people gather, up from 150 people
  • Venues like cinemas and theatres will be able to host up to 70 per cent of capacity with patrons wearing masks indoors
  • Gyms will be able to operate under the one person per two square metre rule
  • Weddings and funerals will be able to have 200 people in attendance

Further, the recommendation to work from home where possible will be removed and masks will no longer be mandatory except for "high risk" individuals.

The use of the QR code check-in system will be expanded to retailers too.

SA chief public health officer Nicola Spurrier said it was great for the state to report no new cases of COVID-19 today and no active cases of the virus.

"I really like zeros," she said.

"Well done, I'm really pleased about that."

The announcement comes after Queensland announced yesterday that travellers from SA would be able to enter the northern state from Saturday.

Updated at 3.22pm AEDT on 8 December 2020.

Queensland to open border to Adelaide from Saturday

Queensland to open border to Adelaide from Saturday

Queensland will permit those living in Adelaide to travel unrestricted into the state from 1am on Saturday 12 December.

The reopening of the QLD border to Adelaide is conditional on the South Australian capital recording no new unlinked cases of COVID-19 before Saturday.

QLD health authorities say the reopening is possible because by Saturday it will have been 28 days since the first case was recorded in connection to the Parafield cluster in Adelaide.

With that outbreak now under control, Queensland it set to welcome those in SA back to the sunshine state for Christmas.

The news comes as Western Australia confirmed it will be reopening its border to residents from New South Wales and Victoria.

That reopening occurred overnight, with those in NSW and VIC now able to cross into WA without having to complete 14 days of self-quarantine on arrival.

It brings the two states in line with other jurisdictions already classified as "very low risk", including the Australian Capital Territory, Queensland, Tasmania and the Northern Territory.

Queensland reported three new cases of COVID-19 yesterday, all returned overseas travellers in hotel quarantine.

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Business News Australia

Dancefloors open up, density limits drop as Victorian restrictions eased further

Dancefloors open up, density limits drop as Victorian restrictions eased further

As of this morning capacity limits on Victorian businesses and hospitality venues have eased and masks are no longer mandatory in a variety of settings as the state moves towards a "COVIDSafe Summer".

Announced yesterday by Premier Daniel Andrews, these freshly eased restrictions will remain in place until at least the end of January, guiding the state through the summer months.

As of 11:59pm yesterday density limits in pubs, restaurants and cafes shifted to one person per two square metres for both indoors and outdoors.

The use of electronic record keeping with a QR code will be mandatory.

For smaller venues there are no density limits if the patron number is under 25.

Retail and beauty services have also moved to the one person per two square metre rule as long as electronic record keeping is introduced.

The cap for funerals and weddings has also been removed, subject to a new density limit of 1 person per 2sqm, and dancefloors at weddings are allowed for up to 50 people.

A dancefloor of 50 people is also allowed at nightclubs.

In gyms, the density limit has moved to one person per four square metres with exercise classes limited to 50 indoors and 100 outdoors.

Masks are only required in a limited number of places: on public transport, in rideshare vehicles and taxis, in some retail settings including indoor shopping centres, supermarkets, department stores and indoor markets.

The state will move to a 50 per cent return for office workers by 11 January, after considering public health advice at the time.

For the public service up to 25 per cent will be able to return to the office from 11 January, moving up to 50 per cent on 8 February.

"Until we have a vaccine and even then, until we have a widely distributed vaccine some aspects of these rules and restrictions must continue to be part of our reality," Premier Daniel Andrews said.

"Our new "COVIDSafe Summer" will be in place until at least the end of January, giving Victorians a bit more certainty about what the next couple of months will look like."

Victoria reported zero new cases of COVID-19 yesterday and zero new deaths while there are still no active cases of the virus in the state.

Updated at 9.36am AEDT on 7 December 2020.

SA defies chief health officer advice, eases restrictions further

SA defies chief health officer advice, eases restrictions further

Social distancing measures imposed on South Australian hospitality operators will be eased effective immediately against the advice of chief health officer Nicola Spurrier (pictured).

As such, operators of hospitality venues in the state will see distancing measures eased from one person per four square metres to one person per two square metres today.

According to the state's police commissioner Grant Stevens the decision was made against the advice of the CHO.

However, the SA Transition Committee determined the change to be appropriate given the resounding uptake of the new QR code check-in system for businesses and venues across the state.

"It was made clear by Professor Spurrier that the preferred way forward and moving into the next phase of this particular response is that we retain social distancing of one person per four square metres across the board, and that we reconsider our position as we move into next week," Stevens said.

"We looked at the performance of the South Australian community in relation to the take up of the use of QR codes, where we are currently over 1.1 million check ins across the state, which is exceptional.

"And also looking at the economic and social factors in relation to the restrictions that are currently in place, and the advice from the Transition Committee as a whole, was that the best course of action would be to move to a distancing requirement of one person per two square metres for hospitality."

Other activities are still restricted to one person per four square metres.

Professor Nicola Spurrier said it was difficult to give the Transition Committee a solid risk assessment at this point in time but she was confident the easing of restrictions could work if the use of the QR code check-in system was taken up across the board.

"Our recommendation from a health perspective was to continue that one per four square metre density requirement and my other advice was that we would reconsider things every couple of days," she said.

"I am providing the best advice that I can and obviously the density requirement in certain venues means that you don't have as many contacts between people. But on the other hand we have the QR readers which really is a game changer."

No new cases of COVID-19 were detected in SA today. There are now just seven active cases in South Australia and 272 people in quarantine.

Yesterday 3,548 South Australians got tested for COVID-19 a low number of tests according to Spurrier.

"That is not really high enough guys, I'd like to see it a little bit higher," she said.

"If you happen to be one of those people with a bit of a sore throat or a runny nose can you please go out and get it done."

Updated at 11.42am AEDT on 4 December 2020.

Aussies to wait for now as UK starts rolling out Pfizer vaccine

Aussies to wait for now as UK starts rolling out Pfizer vaccine

The UK may be ready to roll out the new Pfizer-BioNTech COVID-19 vaccine in the UK, but Australians will have to wait until March for a government-approved program.

The UK government overnight revealed that it will distribute the Pfizer-BioNTech for mass vaccinations from next week as COVID-related deaths in the country edge closer to 60,000. The treatment is said to offer up to 95 per cent protections against COVID-19.

The Medicines and Healthcare Products Regulator Agency in the UK has assessed the vaccine as safe to be distributed next week.

"I'm very proud that the UK is the first place in the world to have a clinically authorised vaccine," British Health Secretary Matt Hancock told the BBC.

Britain will begin immunisations for those most in need, including the residents of aged-care homes. The government has ordered 40 million doses, enough to immunise 20 million people.

"It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again," UK Prime Minister Boris Johnson tweeted.

Meanwhile, the Australian government is progressing towards its own vaccination program which is expects will occur early next year.

"Our advice remains that the timeline for a decision on approval is expected by the end of January 2021 and our planning is for first vaccine delivery in March 2021," says Health Minister Greg Hunt.

"Pfizer continues to work with the Therapeutic Goods Administration, providing data for safety and efficacy as part of the approval process."

In preparation for the program the government today is pushing through parliament the Australian Immunisation Register Amendment (Reporting) Bill 2020.

The purpose of the amendment is designed to ensure compulsory reporting of all vaccinations in the Australian Immunisation Register.

Hunt says these changes will ensure that every Australian can access their vaccine history through this safe and secure register and support the administration of COVID-19 vaccines.

"The Australian Government has acted decisively to secure production and supply agreements to secure early access to 134 million doses of a COVID-19 vaccine to Australians in 2021-21 and 2021-22 through an investment so far of $3.3 billion," he says.

"In addition to the significant investment in COVID-19 vaccines, the Australian government invests over $400 million each year though the National Immunisation Program to protect Australians against 17 vaccine preventable diseases."

Updated at 11.13am AEDT on 3 December 2020.

Massive easing of COVID restrictions to set NSW free

Massive easing of COVID restrictions to set NSW free

NSW Premier Gladys Berejiklian has finally set the state free with a wholesale lifting of restrictions across the hospitality and events sector, paving the way for the performing arts community to get back to work.

The changes, which will see outdoor venues able to accept 100 per cent capacity and indoor venues up to 75 per cent, come as NSW continues to record zero cases of community transmissions.

The current rule of one person per four square metres for indoor venues will be eased to one per two square metres. Venue caps also will be removed on events such as weddings and funerals. The only exceptions at this stage are gyms and nightclubs which must adhere to the four-square-metre restrictions.

The changes will come into effect from Monday, 7 December.

"We are grateful to the people in NSW for their patience and understanding over what has been an incredibly difficult year," Berejiklian says.

"The rolling back of restrictions across the state is only possible because of the excellent work of the community who have followed social distancing guidelines and continued to come forward for testing."

The new rules to apply in NSW from next week are:

Venues including hospitality venues, retail and places of worship:

  • one person per two square metres (with 25 people permitted before the rule applies), except for gyms and nightclubs (one person per four square metres with a maximum of 50 people allowed in gym classes or on the dance floor at nightclubs).

Stadiums and theatres:

  • outdoors: 100 per cent seated capacity, and one person per two square metres for unstructured seating areas
  • indoors: 75 per cent seated capacity.

Gatherings in outdoor public spaces:

  • up to 100 people for outdoor gatherings (up from 50)
  • up to 5,000 people for outdoor events that are fenced, ticketed and seated (subject to the two-square-metre rule)
  • up to 3,000 people for other organised outdoor events, such as community sport and outdoor protests (subject to the two-square-metre rule).

Dance floors:

  • up to 50 people indoors.

Singing:

  • up to 50 performers indoors, no maximum cap outdoors
  • advice is for the congregation or audience to continue wearing masks if singing.

Under the changes, maximum capacity caps will be removed subject to the two-square-metre rule for:

  • bookings at hospitality venues
  • weddings
  • funerals
  • regional agricultural shows
  • corporate events
  • religious services.

Deputy Premier John Barilaro says the people of NSW have worked hard to keep COVID-19 under control and deserved this major easing of restrictions.

"Today is a great day for the people of NSW and great timing with Christmas fast approaching, as we will soon see larger crowds at venues and events and the expansion of the two-square-metre rule statewide," he says.

Under the changes, most venues will be able to double their capacity, which will have an immediate and substantial impact on the economy.

"This change will make a big difference to many businesses and will provide a real boost for jobs particularly in the service industry which has been hit hard over the past nine months," says Treasurer Dominic Perrottet.

NSW warns that despite the easing of restrictions, the public needs to remain COVID-safe, urging anyone to get tested and avoid going to work if they have the slightest symptoms, and to continue maintain social distancing.

"It is critical that people continue to come forward for testing and practice COVID-safe behaviour when out and about and catching up with family and friends," says NSW chief health officer Dr Kerry Chant.

Updated at 3.26pm AEDT on 2 December 2020.

FDA fast tracks Mesoblast COVID-19 treatment

FDA fast tracks Mesoblast COVID-19 treatment

A COVID-19 treatment being developed by Australian pharmaceutical company Mesoblast (ASX: MSB) has been granted Fast Track designation by the US Food and Drug Administration (FDA) today.

The designation is for MSB's treatment of acute respiratory distress syndrome (ARDs) - a potentially fatal complication of COVID-19 infection called remestemcel-L.

As a result, the FDA will assist in the development of remestemcel-L and will expedite the review of the drug because it fills an unmet medical need.

Under Fast Track designation, a Biologic License Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review.

In its submission to the FDA Mesoblast highlighted results from a pilot study of remestemcel-L under emergency compassionate use at New York's Mt Sinai Hospital in March-April this year.

In this study, nine of 12 ventilator-dependent patients with moderate to severe COVID-19 ARDS were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L.

An ongoing Phase 3 trial of the drug in up to 300 ventilator-dependent patients is approximately two thirds enrolled.

Two interim analyses of this trial have been performed by the independent Data Safety Monitoring Board (DSMB), with recommendations to continue the trial.

Receipt of the Fast Track designation comes after Mesoblast entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialisation of remestemcel-L.

As part of the deal Switzerland-based Novartis will make a US$50 million (AUD$68.7 million) upfront payment to Mesoblast.

Following the initiation of a Phase 3 clinical trial, Novartis will fully fund the global clinical development of the drug.

In addition, Mesoblast may receive a total of US$505 million (AUD$694 million) pending achievement of pre-commercialisation milestones for remestemcel-L and a further US$750 million (AUD$1 billion) based on achieving certain sales milestones.

Mesoblast will retain full rights for the use of remestemcel-L for treatment of graft versus host disease.

Updated at 9.58am AEDT on 2 December 2020.

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