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COVID-19 Northern Rivers News

TGA Approves Pfizer’s Novel COVID-19 Oral Treatment in Australia

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The NSW Northern Rivers Times COVID19 News Updates

TGA Approves Pfizer’s Novel COVID-19 Oral Treatment in Australia

• Therapeutic Goods Administration (TGA) approves PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for supply to Australia.

• PAXLOVID is the first oral treatment of its kind; it includes nirmatrelvir, a 3CL (or main) protease inhibitor that was specifically designed to combat SARS-CoV-2.

• Pfizer Australia has entered an agreement with the Australian Government to supply 500,000 treatment courses over 2022.

SYDNEY, AUSTRALIA, 20 January 2021 – Pfizer announced today that Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval for the supply and use in Australia of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets. PAXLOVID has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death.

PAXLOVID is the first oral antiviral of its kind; it includes nirmatrelvir, a 3CL protease (also known as Main protease or Mpro) inhibitor that was specifically developed in Pfizer’s laboratories to combat SARS-CoV-2. Under this authorisation, PAXLOVID can be prescribed as an oral treatment to certain high-risk adults within the first 5 days of symptomatic infection, potentially helping patients avoid severe illness which can lead to hospitalisation or death.

“This milestone in Australia is an important moment in our continued fight against COVID-19, paving the way for use of PAXLOVID as cases continue to rise and we address the threat of a new variant of concern, Omicron,” said Anne Harris, Pfizer Australia and New Zealand Managing Director. “This at-oral therapy, developed to reduce hospitalisations and save lives, has the potential to transform COVID-19 treatment and help lessen the devastating impact of the virus that has now taken over 5 million lives globally”, Ms Harris said.

The TGA based its decision on positive results from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) interim analysis, which enrolled non-hospitalised adults with confirmed COVID-19 who were at increased risk of progressing to severe illness. The data demonstrated an 89% reduction in risk of COVID-19-related hospitalisation or death from any cause in adults treated with PAXLOVID compared to placebo in those treated within three days of symptom onset, with no deaths in the treatment group. Similar results were seen in those treated within five days of symptom onset. Treatment-emergent adverse events were comparable between PAXLOVID (19%) and placebo (21%), most of which were mild in intensity. Pfizer recently announced that results from the final analysis of the primary endpoint from all patients enrolled in EPIC-HR were consistent with the interim analysis, confirming efficacy with a similar safety profile. Additional Phase 2/3 clinical trials are ongoing in adults at standard risk of progressing to severe illness, and in those who have been exposed to the virus through household contacts.

In October 2021, Pfizer announced an agreement with the Australian Government to supply 500,000 treatment courses of PAXLOVID over 2022. With the oral treatment now approved for supply and use by the TGA, Pfizer will begin delivering the first treatment courses from Q1 2022.

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2022 Floods

Housing demand creates planning challenges

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NSW Northern Rivers Breaking News

Housing demand creates planning challenges

The current lack of affordable and diverse housing for buyers and renters is a crisis which is confronting all levels of government.

A move to regional areas, limited government investment in social housing, a boom in short terms rentals, COVID-19, the recent floods and inflation have put great pressures on the property market.

While housing is primarily the responsibility of federal and state governments, Tweed Shire Council plays a key role as a determining authority/regulator for housing and planning law.

 

Council acts on unauthorised dwellings. Over the last 2 years, Council has contributed to an increased supply of affordable housing by encouraging diverse and affordable housing through the approval of more than 130 DAs involving secondary dwelling (granny flats) development controls, in addition to established dual occupancy controls.

In recognising the housing crisis, Council has worked collectively through the Northern Rivers Joint Organisation (NRJO) and Local Government NSW, to be an advocate for action on new social housing supply and affordability policies.

Over the last 2 years, Council has contributed to an increased supply of affordable housing by encouraging diverse and affordable housing through the approval of more than 130 DAs involving secondary dwelling (granny flats) development controls, in addition to established dual occupancy controls.

Attached dual occupancy dwellings are also possible in many rural areas, in addition to established urban areas.

More information can be found at tweed.nsw.gov.au/granny-flats-secondary dwellings

Additional dual occupancy information can also be found at tweed.nsw.gov.au/dual-occupancy

While Council provides a supportive approach to people affected by the housing crisis, it also has an important statutory responsibility to ensure that any land uses or building works provide a safe and secure housing.

Council recently resolved at its 7 July 2022 meeting to reinforce its role in undertaking compliance action on unauthorised dwellings.

General Manager Troy Green said Council had rescinded the resolution at Item 21.1 of the 2 June 2022 Confidential Council Meeting. The resolution sought to extend an initial moratorium from its 4 November 2021 meeting on taking compliance action on unauthorised dwellings up until 30 September 2022.

“After attending a workshop and gaining additional advice from staff, Councillors acknowledged there may be significant risks for Council to extend the earlier moratorium,” Mr Green said.

“In response to the potential risk and liability identified, it was agreed that a late report be submitted to the Extraordinary Council Meeting of 7 July 2022, seeking to rescind Council’s resolution from the 2 June 2022 meeting.

“Council also resolved that any new compliance matters would be subject to the current requirements of Council’s adopted Compliance Policy.”

Unauthorised building works carried out without required formal approval and certification can pose significant risk to life and property.

In other scenarios, unauthorised building works could also be poorly located on sites which are flood prone, bushfire prone, contaminated or landslip areas and thereby present similar life-threatening, public health and environmental hazards.

Council encourages people to undertake their land use activities with proper consent and approvals to avoid causing a nuisance or acting in breach of legislation.

Council has a compliance policy which guides the approach and response to a range of compliance issues.

However we also rely on the community to report unauthorised work and provide evidence to assist Council in taking action.

Compliance officers use their discretion when dealing with such matters, taking into account the evidence, cost to the community of any action, details of the case, public policy and legal precedent.

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COVID-19 Northern Rivers News

PEOPLE WITH DISABILITY URGED TO GET BOOSTER

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PEOPLE WITH DISABILITY URGED TO GET BOOSTER

PEOPLE WITH DISABILITY URGED TO GET BOOSTER

With a new wave of COVID-19 cases continuing to increase across the state, people with disability are encouraged to get the latest COVID-19 vaccine booster dose.
Minister for Families and Communities and Minister for Disability Services Natasha Maclaren-Jones said people with disability can be more vulnerable to the harmful effects of COVID-19.
“Protecting people with disability is vital as they can be at greater risk of developing serious illness if they become infected,” Mrs Maclaren-Jones said.
“Vaccination is readily available at GPs and pharmacies and we are urging everyone to book in without delay.”
COVID-19 booster doses are recommended for anyone 16 years and older who had their last dose of a primary course at least three months ago.
The COVID-19 vaccine can be taken at the same time as the influenza vaccine, which people with disability are also being urged to take.
While the free flu vaccination program in NSW ends on 17 July 2022, those considered to be at higher risk of severe illness from influenza remain eligible for a FREE flu vaccine beyond this date, under the National Immunisation program. This includes:
• Aboriginal and Torres Strait Islander people from six months of age
• Children from six months to under five years of age
• People with serious health conditions (including severe asthma, diabetes, cancer, immune disorders, obesity, kidney, heart, lung or liver disease)
• Pregnant women
• People aged 65 and over.
The NSW Government is also providing up to 7.9 million rapid antigen tests (RATs) to people with disability and other vulnerable community members with the program recently expanded to 31 October 2022.
To find your nearest vaccination clinic, visit nsw.gov.au.

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COVID-19 Northern Rivers News

Royal Australian College of GPs COVID-19 antiviral treatment

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NSW Northern Rivers Breaking News

Royal Australian College of GPs

The Royal Australian College of General Practitioners (RACGP) has welcomed the expansion of COVID-19 antiviral treatment access.

It follows federal Minister for Health and Aged Care Mark Butler announcing that eligibility for lifesaving COVID-19 antiviral treatments will be widened. From today, access will be expanded under the Pharmaceutical Benefits Scheme to the following patients who test positive to COVID-19:

  • all those aged over 70
  • people aged over 50 with two or more risk factors for severe disease
  • Aboriginal or Torres Strait Islander people aged over 30 with two or more risk factors for severe disease
  • immunocompromised people over 18 may also be eligible.

RACGP Vice President Dr Bruce Willett welcomed the expansion.

“This is a sound and timely decision that will make a real difference for many patients across Australia,” he said.

“In communities everywhere, we have high rates of community transmission of COVID-19, and we know that some patients are particularly vulnerable to severe effects. By expanding access to the antivirals, we can help keep people out of hospital, relieve pressure on the entire health system and save lives.”

Dr Willett said that once again GPs and general practice teams will be front and centre.

“General practice is the backbone of the COVID-19 vaccine rollout, and we play an essential role getting people timely access to these potentially lifesaving antivirals,” he said.

“GPs are the key to safely prescribing these treatments. We have a strong and, in many cases, long-standing connection with our patients and understand their life circumstances including existing health conditions or other factors such as plans to become pregnant. We also have a comprehensive understanding of how these antivirals interact with other drugs and established systems such as telehealth, so GPs can speak with COVID-19-positive patients safely and prescribe the right antiviral without delay.”

The RACGP Vice President said that that more must be done to fight complacency and contain the harm caused by COVID-19.

“Expanding eligibility is vital; however, we must also enhance community awareness around antivirals and ensure that those patient groups most vulnerable to severe effects from the virus access these drugs. They can save your life if taken early enough,” he said.

“People who believe they are eligible for an antiviral should make an appointment with their GP now to plan how they can receive the drugs if they test positive. Because the drugs are listed on the Pharmaceutical Benefits Scheme, a GP will not be able to prescribe an antiviral until the patient actually has COVID-19. So, for those eligible – as soon as you get a positive rapid antigen test or a positive PCR test, call your GP and, if you can’t talk to them, leave a phone message to say you have tested positive and you need a prescription.

“The reason this is so important is that with these treatments we must act quickly. The antivirals have to be given within five days, and they become less effective as you get closer to day five. So, getting that message out there is essential, and I encourage everyone to have conversations with people in their life about these treatments.”

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