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Are floodgates are about to open...TGA approval imminent???, page-2

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Maz2024

42 Posts.

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03/04/24

21:45

Post #: 73176532
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Originally posted by antibotter: ↑

Are the floodgates about to open
Is a TGA approval imminent for VIRALEZE™

You would think so (haha)

The Long Standing Conspiracy Theory Confirmed
The regulartory body has established in writing what everyone has been speculating on for the last few years
The government has on purpose prevented Viraleze from being approved in Australia until now

Comment from the delegate

I agree with the Committee that increased access to astodrimer sodium nasal sprays may delay people from seeking medical attention, as well as deterring vaccination, mask wearing, and other standard precautionary measures to prevent transmission of viral respiratory diseases.However, in considering SPF factors, I am satisfied that the risk of the substance masking the symptoms or Therapeutic Goods Administration Notice of interim decisions to amend (or not amend) the current Poisons Standard (November 2023) Page 8 of 60 delaying diagnosis of a serious condition is unlikely, and as such aligns with the considerations for a Schedule 2 entry.

Did you see how many public submissions were made for viraleze (167) versus for all other considerations (between 20 - 30)

I have taken the time to put some of the comments made for easy access

How many of the comments were from holders of Starpharma is debatable

I support Astodrimer as it will help me feel safe in crowded situations. lives overseas and she uses it all the time to stay safe from circulating viruses and I would like to be able to access it here please.
With continued emergence of new variant C19 people need affordable nasal sprays to inhibit intranasal uptake of virus. In desperation I just purchased again at $78 per unit. It is disgusting that Australians must wait for an effective and safe product that’s been available in other countries for at least two years. Especially as it’s an Australian product!
Low risk
Having a nasal spray containing Astodrimer sodium readily available to control throat infections would be extremely helpful for the general population as it would avoid the need for medical appointments and the socio-economic constraints this imposes. It would also allow a more rapid and effective response to nasal and throat viral infections such as a cold or flu
I have used the Astodrimer sodium (ASNS) nasal spray, , which afriend brought back from Europe for me, under the TGA allowed 3mth Personal Importation scheme of unapproved medications.

For decades, although never a smoker, I have suffered chronic cough, post nasal drip and blocked sinus. This worsens if I catch viral respiratory infections such as common colds or flu. Invariably common colds turn to bronchitis and need one or two courses of antibiotics to clear the secondary infection so avoiding them it very important to me. I’ve been taking for almost a year and hoping also to clear sinus problems which ultra sound revealed included a bacterial patch and my ENT specialist said it needed a hospital operation to remove. was remarkably effective with absolutely no adverse effects. Using only once a day until my hospital appointment my nose has NEVER felt better - although I still have the tickle of a cough, the post nasal drip improved and when examined by the registrar pre op we decided that the sinus had recovered and no operation was needed.
I really hope that TGA approve this for over the counter pharmacy sale like many other nasal sprays which are less effective. There is no irritation with AS Nasal Spray unlike many others OTC sprays where sneezing, tickling and even bleeding occurs. Preventing and treating respiratory infections is so important to the community - this is far better than anything else I have used.

Before using medications, I read the studies and information on the internet. International references
In UK the ASNS is approved as a Barrier Nasal Spray approved by UK MHRA March 2022 and EU Medical Device approval November 2020. Marketed in Netherlands/ Manu in Belgium and described as ANTIVIRAL NASAL SPRAY for multiple viruses (common cold is of course a VIRUS). EU EMA is recognised in Australian legislation as the expert in Nano Particles and TGA is recommended to refer to them. AS SP7013 is part of the dendrimer range of nanoparticle chemicals already TGA approved unscheduled in condoms and as BV treatment and preventative for BV.I find it strange that in “Proposed amendments to the Poisons Standard – ACMS, ACCS and Joint ACMS-ACCS meetings, November 2023” 1.1 INTERNATIONAL REGULATIONS which the delegate is currently reviewing and to which I am responding, there is no mention of European Medical Device approval Nov 2020 or UK MHRA MD revised 2022/03 P712362 PM05002 and ask that the delegate refer to those INCLUSIONS and not just the EXCLUSIONS listed.

In the UK the post marketing study of ASNS brand name , has recently completed participant data collection, with results to be published in Q4/2023 so hopefully that human placebo controlled study of over 200 covid positive participants will complete before the FINAL report of the delegate and inform whether COMMON COLD is the relevant condition for packaging information or SAR-COV2.

https://cdn-api.markitdigital.com/a...access_token=83ff96335c2d45a094df02a206a39ff4

This international information should inform the TGA delegate prior to decision at the November committee meeting but if study results are later it will be available at any appeal stage of the delegates decision if application is unsuccessful or needs amendments.

AS has undergone a safety placebo controlled trial in WA which showed that it is exceptionally safe in the nasal mucosa
https://www.researchgate.net/journa...olerated-in-a-randomized-controlled-trial.pdf

AND significantly there is no absorption into the bloodstream as it is a surface barrier by fine nano particle nasal spray.
"The finding that astodrimer sodium was not detected in the bloodstream following repeated nasal application is consistent with previous extensive nonclinical and clinical data showing lack of absorption into the blood- stream following topical application to mucosal membranes21,22. Therefore, systemic adverse events would not be expected to occur from nasal administration of astodrimer sodium, and there was no evidence of such events occurring in the current investigation"

Scripps Research Institute has tested AS from August 2020 to 2023, on humanised mouse genome which was nominated early in the pandemic by WHO as an appropriate in-vivo test where population vaccine and exposure status lacks stability for accurate human trials. ie As noted in the report to the re Vaccines and Treatments, PF-07321332 trials from March 2021 were conducted on unvaccinated persons and approved by FDA in late 2021 under EUA with an efficacy of 86%, in seeking full authorisation conducted further trials reported mid 2022 which selected vaccinated participants and saw the efficacy drop to 51% no better statistically than the placebo group. Variant changes and number of boosters also have effected results for most vaccines in the pandemic making the WHO recommendation to use controlled humanised genome mice a rational choice which I think the TGA should also support. ASNS SP7013 aka had stunning results of 99.9% inactivation of all variants up to Kappa were achieved within 30 secs - see table in that report and reference reports.
https://www.scripps.edu/gallay/sars-cov-2.html.
The advantage of Scripps trials is that dissection of the mice afterwards can show if the virus is present in organs - lungs, trachea, nasal mucosa, brain , heart and liver and that detection was almost nil in all tests. As SARS COV2 is a Coronavirus and a particularly dangerous one in the pandemic, the common cold is also a coronavirus in most of its forms. Needless to say I have not had covid in the three years of the pandemic and after staying home during the first years of the pandemic, feel I can confidently go out now protected by the antiviral nasal spray which prevents multi viruses.

It is also interesting that Lloyds Pharmacy in the UK had discounted to £2 a bottle in April this year and was selling over 2000 bottles a day with 5 star rating and excellent customer reviews. It is very goodWhen family members or social contacts have a cold or flu I just spray my nose and I haven’t caught a cold or flu or covid during the time I’ve used this spray. Not only do I support Astodrimer sodium nasal spray for common cold being approved as an over the counter pharmacy product but I would support further applications to include Covid treatment and preventative when the UK NHS results on are published. Over 16 million Australians, mostly working age, have no access to antivirals as Covid19 preventatives or treatments with the restrictions applied to (nirmatrelvir and ritonavir), (remdesivir) & failed (molnupiravir). All Australians, unless they legally import or under the 3mth personal importation scheme, have no access to antivirals as preventatives.Please approve this application - it is probably one of the most important decisions TGA could rectify

Astodrimer sodium barrier nasal sprays will be of very HIGH BENEFIT in protecting healthcare and allied healthcare workers such as myself (Registered PSYCHOLOGIST) who are at significant risk of contracting the cold virus through the close personal physical interaction with clients and patients required in the delivery of healthcare services.

With the high level of cold and respiratory viruses circulating I am currently avoiding face-to-face interaction with clients, but remote interaction via video-conferencing limits my ability to build a professional relationship and trusting rapport with clients. This is ADVERSELY IMPACTING my ability to deliver effective psychological assessments and interventions. Astodrimer sodium barrier nasal sprays will lower the risk of infection and enable me to more fully interact face-to-face with clients and provide a full range of psychological services.

I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

Daryl Wightman
Registered Psychologist
AHPRA registration

Contracting the cold virus affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

I am writing in support of the approval for to be sold in Australia. Many nasal sprays, including , have been shown to provide a protective barrier to prevent infection with cold and respiratory viruses. is readily available in many other countries, including the UK, and people living in Australia would benefit from having another nasal spray option, particularly in light of the ongoing pandemic
write to support an update of Schedule 3 so me and my family can use astodrimer sodium barrier nasal sprays that research has shown would be beneficial for our health.

https://www.nature.com/articles/s41598-022-14601-3#:~:text=Mechanism of action studies indicate,2 (ACE2) receptor13.

This has been a crucial part of my health process but I can't get it in the country I live in ,Australia please leave me a health option of this product

I have Cystic Fibrosis any help reducing the chances of a severe cold is much appreciated. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays

I strongly support the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. The product is designed as a barrier prophylaxis to reduce symptoms of respiratory virus and should be approved for such use.

Already registered across the 27 countries of the European Union and the UK and Asia, it is another addition to already approved products to reduce symptoms of a cold such as First Defence nasal spray.

The National Institute of Health study found no adverse effects and it was well tolerated in a randomised control trial.

It is a Melbourne designed product licensed overseas and it would be sensible to launch here as well, given its success overseas.

Personal benefits for this product being available are for personal relief from colds, meaning less time off work. It is a convenient, cheap and easy to use solution that has no ill effects on me. The public already has access to nasal sprays to treat colds and allergies so are used to using the product.

STRONGLY SUPPORT the amendment to Schedule 3 for the above nasal spray, as catching the cold virus impedes my ability to participate in employment.

I strongly support the approval of this product. It will help my family avoid colds, and will therefore allow us to continue to work, study and play.

Contracting the cold impacts my ability to earn and support myself. This would help against that. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays”

Being infected with common cold viruses has a significant impact on my ability to work, and leads me to take increased sick leave. I am in strong support for the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

PREVENTS COVID INFECTION
SARS COV 2 IS BAD AND SHOULD BE AVOIDED
WE NEED ALL THE TOOLS
BE REAL
I strongly support the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. Getting sick from colds affects my ability to earn a living and care for my family as I often end up with secondary middle ear and sinus infections from mild colds. Availability of a preventive nasal spray would help me to stay healthy.

Catching colds and illnesses hinders my ability to care for my children. I strongly support astodrimer sodium sprays like being made available to the Australian public.

Contracting the cold virus affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays

As someone who works in healthcare, I am exposed to respiratory viruses a lot more than the average person and as such, often am on sick leave. I strongly support the proposed changes to approve nasal spray containing astodrimer sodium so that I and many others in healthcare settings can avoid getting sick with colds and flus as often, especially considering the current shortages happening at the moment. Being able to use a low cost low risk OTC nasal spray such as those containing this active ingredient to avoid the common cold would be a welcome change.

As a Respiratory Physician I would like myself and my patients to have access to Astodrimer Sodium as a barrier nasal spray. A barrier nasal spray may help to prevent upper respiratory tract infections which may in turn reduce exacerbations of lung diseases like COPD which have a devastating impact on my patients. I would like to strongly advocate that this is made available as soon as possible.

Contracting the cold and covid viruses affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays

I have an autoimmune disease and contracting viruses like the common cold triggers my immune system to attack my own body. This impacts my health, quality of life and productivity. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. It would hugely benefit me and others like me. Thanks for your consideration
This will help me to carry on safely and well in my role as an educational tutor.

Contracting the cold virus affects my ability to work effectively, and my children’s ability to attend school. Consequently, I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.
As someone who works in close quarters as a FIFO worker, contracting a the cold virus on either the plane flights to and from site or whilst living at work drastically affects my ability to work effectively (and spreads rapidly amongst the workers, leading to even lower productivity).
Therefore I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

Contracting the cold virus affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

I would like the chance to use this due to immune dysfunction and an excessive vulnerability to viral infections, including suffering from a post-viral syndrome for more than 25 years.

As I suffer from a chronic health condition where colds can wipe me out, having a nasal barrier spray that would help to protect from colds would be very beneficial.

Useful for the cold

I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. My husband is immunocompromised and it would hugely benefit him and others like him. Thanks for your consideration.

Please make this available in Australia as it will make it much safer for those of us with various health issues to avoid covid and continue to live and work. It’s essential for us to have this to assist.

Reducing the impact of colds is important to me so that I can come to us to work and provide care giving duties.

support this proposal provided there is sufficient safety data in human trials. The TGA should satisfy itself that no adverse active ingredients are absorbed into the bloodstream, children will undoubtedly use this product whether the packaging advises this is safe or not.

The use case for a product that blocks transmission or reduces viral load and PCR positivity is absolutely compelling. As a user of layered mitigation, I have incorporated the use of (Carrageenan) spray into my daily life, before and after potential exposure in conjunction with N95 masking. This is based on quite a small study, more robust trials head to head of , and would be welcome.

As things stand, public health in Australia is failing. We have XBB variants and highly immune evasive BA.2.86 in our wastewater, but no announcement about imminent XBB vaccine procurement for Australia. This, despite many citizens' boosters waning in efficacy and the virus causing multiple waves per year, including in summer.

Even the National Cabinet statement Dec 9 2022 said it will not be endemic for "some years". So, it's epidemic. We are still in a pandemic, regardless of Urgency of Normal politicking.

PCR testing is restricted. Rapid antigen tests require serial use to lift sensitivity. Mandatory isolation was lifted without AHPPC backing and sick children attend school unmasked. Masking is almost nonexistent, even in essential services like health care.

Any extra layer of protection, however minor, like a nasal spray, that can be made available to the public over the counter, should be, urgently, provided it is safe.

I am immunocompromised and at increased risk of severe Covid, long Covid and other post Covid sequelae. My understanding is that Astodrimer Sodium is safe and another layer in the Swiss cheese model to reduce transmission of Covid. We need every measure we can get to take personal responsibility to minimise risk of infection the context of minimal mitigations being taken in the community at large.

Contracting the cold virus affects my ability to work effectively.

I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays”

I work in an environment where I come into contact with a large number of people. This puts me an others at risk of contracting or spreading a common cold virus, which in turn will affect my ability to work effectively. Therefore, I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

Strongly support this as a means to help office workers protect themselves .

Contracting the cold virus affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. At the moment, I buy from overseas, and it is very expensive.

I strongly support the proposed changes for Astodrimer Sodium. Contracting the cold virus affects my ability to work effectively. The availability of products containing the above ingredient would be of great use in order to be able to work.

The current spread of respiratory viruses is making society and healthcare inaccessible for medically vulnerable people - to counter this, we need as many options as possible to allow people to protect themselves from respiratory viruses. ASTODRIMER SODIUM could be an important tool to keep people safer and remove barriers which medically vulnerable people face in accessing healthcare, employment, and society generally. Fully support its approval.

I support the proposal for astrodrimer sodium, manufactured in Australia as the product , to be able for sale to the Australian public as it has been shown overseas (where it is freely able for public purchase) to be a safe and efficacious nasal spray medication to be used during the covid pandemic we are currently dealing with.
Thank you for considering my proposal for support of this product.

I strongly support the amendment to Schedule 3 for Astodrimer sodium barrier nasal spray, as contracting a cold interferes with my ability to work

We need better protections against respiratory viruses. I have seen too many people become so unwell this year and they deserve to be able to protect themselves.

I am a teacher so having access to this product will reduce the number of sick days I have.

There have been a lot of cold viruses lately. Contracting cold viruses affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.
I teach at least 5 classes of primary aged children over a day. Schools are the major site of transmission of airborne viruses, sickness with which is a major cause of increased absenteeism among teachers and students (who then suffer negative impacts on their academic achievement).

Contracting the cold virus or worse not only affects my ability to work effectively, but has implications for my long term health and continued participation in the teaching workforce. I need to continue working and there is already a dire teacher shortage here.

Moreover, repeated exposure of children to Covid-19 at school increases the likelihood of them developing associated chronic health conditions. It is in society’s interest to reduce the spread of these viruses as these children are our future.

These days there are few mitigations I can take to prevent contracting airborne viruses and passing them on to my students (or vice versa). This nasal spray has proven efficacy and I need it to continue to protect my health.

I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

I welcome and wish for the ability to avoid the common cold virus by being able to use the Astodrimer Sodium - this would allow me to be more productive throughout the year and be less prone to getting run down and the prolonging of symptoms and time off with illness due to the common cold virus- I fully support the proposal.

I find that as I get older (I’ll be 60 in December), that getting even a common cold virus affects my ability to work effectively, and it takes me longer to recover.

That’s why I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

I also think it’s very important to support Australian-led medical research discoveries, and encourage commercialisation.

I welcome and wish for the ability to avoid the common cold virus by being able to use the Astodrimer Sodium - this would allow me to be more productive throughout the year and be less prone to getting run down and the prolonging of symptoms and time off with illness due to the common cold virus- I fully support the proposal.

With continued evidence that there is increasing severity and recurrence of illness in the community, things like the cold virus is constantly circulating and can impact the ability of many to work effectively as well as impact quality of life. We need as many of the tools as possible to assist with prevention. I therefore STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays” as added support against cold viruses.

I am a primary school teacher who is often contracting colds and needing to stay away from work, I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. I would find it highly beneficial.

I am a self employed carer. Contracting any type of cold virus affects my ability to work effectively and safely. If I don’t work I have NO income. I therefore STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays!

Contracting the cold virus affects my ability to work effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays

This product has shown substantial efficacy in reducing the effects of COVID-19 infection and is a simple, easy tool to mitigate the further spread of something that’s killed nearly 10,000 Australians in the last year (and disabled thousands of others)

I presently use a nasal spray in certain situations in order to reduce my risk of contracting viral infections (such as colds etc.), and I would like to have the opportunity to try and perhaps choose one containing astodrimer sodium in case it works better or has less side effects than the one I am presently using.

It's not reasonable that Australian citizens are unable to obtain nasal spray from within Australia when it is widely available in other comporable countries: comporable in the sense of high quality regulatory and scientific systems.
Since the federal government (& national cabinet) have told us we are responsible for our own health (ie. there is only private/personal health strategies and no longer any support for long established pandemic public health infection control standards) it is imperative that products such as are made available. It should have been available long ago.

This substance has been in use in other preparations with an excellent safety record. It is a surface barrier product with no evidence of absorption into tissues or bloodstream, further reinforcing it's safety profile for use by consumers with complex co-morbidities. It's proven track record in blocking numerous viruses makes it a highly valuable, low cost, low risk accessible tool in reducing the transmission of multiple airborne pathogens. It is already in use in multiple international jurisdictions with no evidence of significant adverse reactions. This product has the potential to have a significant public health benefit, not just in mitigating the ongoing SARS-CoV-2 pandemic, but in reduction of all type airborne illness and their associated human & economic costs.

I strongly support the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays which have been shown to be very safe and effective against coronaviruses such as the common cold. As I have an autoimmune condition which is made worse by viruses, any additional layer of protection that prevents or lessens infection is very welcome.

I strongly support the amendments to allow wider access to the barrier nasal spray. This would enable me to participate more fully in my place of employment among children.

I have been using myself here in Australia for the past 5 months after purchased it in Ireland from website which had it sent to them and then forwarded onto my for personal use as allowed by the Australian regulations for personal use. Since it is not available here in Australia , it’s he only way we can get it. I also wear a N95 mask as I have to visit hospitals for monthly venesection for haemochromatosis and am high risk with asthma and had a radical hysterectomy 2 years ago for uterine cancer … margins not clear…genetic cancer..lynch syndrome..which means I have been in and out if medical care with cat scans, and other treatments. And after all that, my doctors are astonished I gave not gotten covid. I smile and show them what I call, my savour…. They are shocked that they never heard if it and shocked it has not been approved yet here in Australia and say…what ever your doing keep doing it as it’s rare to find someone as vulnerable as myself… in high risk environments not picked up covid. I also would like to add my twin brother uses it too and was at the dentist recently, so had to be unmasked, and the nurse was sick and coughing, he did not get the flu off her afterwards… as she was very unwell. He believes helped him not get sick. The fact is we have been using this wonderful potential life saving product, for months, we have no side effects, .. it is comforting to know that you are protected, I still keep all my boosters up to date, but is that one extra element to help stop viruses entering the nasal passage. I have a nursing background…I read the science, I watch the stats … I look overseas at what us coming down the pipeline with new variants and would live the rest of the Australian population to have the opportunity to purchase here in Australia and have a very high chance of not getting covid or long covid with wave after wave of infections rolling through the communities… they also would be protected from flu, Bird flu, swine flu and other debilitating respiratory viruses. And the cost benefit to the community would be so beneficial with less workers going off sick.. saving potentially millions. Australia would be one of the powerhouse countries with booming industries….full workforce’s all for the want of a little bottle of nasal spray to keep viruses at bay, hospitals would not have the critical burdens … surgeries would not be cancelled, suck patients in hospitals would not pick up covid in hospital and die at 10% death rate … it’s time all Australians learned about . Millions are using it overseas… we should too. The cost of asking family and friends to buy it, wears thin after the 3rd order…it’s a lot to ask and we shouldn’t have to do it. And lastly, and this is extremely hard for me to admit, but I was given a recommendation to purchase from a online store, I was desperate to get it, and knew better.. but it seemed like a good idea at the time, we’ll long story short it was a Australian con artist .. and he took my money and 5 months later, still no delivery. I am ashamed and devastated as other family and friends also were conned too.. once again, I should not have to try and buy outside Australia and end up in the arms if con artists…costing thousands we all will never get back. The trauma and guilt I feel from the whole ordeal has been taxing on my fragile health. I rather give my limited funds to a licensed chemist here in Australia… keep the money here and not send it overseas.

Sorry for rambling on, I have read all the studies on all nasal antiviral sprays and came out in top… it not only protects you from getting covid but if you do get it, the antiviral properties will help, you fight it off. I have heard plenty of stories from people who returned from Europe and picked up overseas … and then either them or son or daughter picked up covid on the plane… treated with and by day 3 RAT was negative. It definitely fought off the worst of covid.

So I am submitting by story and my covid free status with the extra protection and use of with no side effects, no issues at all… and am far more confident visiting medical establishments…the local shops without trembling at the knees at the thought of catching covid and making me very very sick or at worse, Killing me as I am in the targeted group not to get covid ….female..57.. with serous underlying medical conditions.

I really feel it has saved my life…

It needs to save other lives too…

please approve …for sale in Australia as it has been approved and sold oversea with no issues or concerns by many other well established medical and government agencies.

I support the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays” I suffer from RA, SLE and have reoccurring nasal infections. I need this astodrimer sodium barrier nasal spray. Thank you.

ASTODRIMER SODIUM (in products such as ) has been shown as safe and effective in reducing the viral load of SARS-CoV-2, influenza, and respiratory syncytial virus (RSV). Given it is already approved in Europe, it should be allowed in Australia so the public can better protect themselves against outbreaks.

My elderly parents have found that an astodrimer sodium barrier nasal spray () is the most effective at preventing colds, but they cannot purchase it in Australia. I strongly support the proposal for astodrimer sodium because if the proposed changes are made it will help protect their health.

Strongly support this to reduce work absence due to illness.

The non-serious and self-limiting nature of the condition (the common cold) is consistent with the risk profile of over-the-counter (OTC) medicines. Similar products used in the treatment of the condition are OTC medicines and readily available in Australia.

The purpose of astodrimer sodium inclusion in a nasal spray product is to act as a physical barrier to trap and block cold viruses such as the common cold, allowing the body’s natural defences to remove them with the nasal mucus.

Astodrimer sodium poses low risk of harm, as noted in the delegate’s previous decision in November 2021. The risks associated with misuse, abuse and overuse are very low. Astodrimer sodium is not systemically absorbed when used as a barrier nasal spray.

Adverse effects are rare and well-characterised; with no known interactions with commonly used food and consumables, or contra-indications. The risk profile of the substance is well defined, and risks can be appropriately managed through labelling and packaging.

The use of astodrimer sodium in a nasal spray is not likely to mask the symptoms or delay diagnosis of a serious condition. Appropriate labelling and packaging can manage any perceived risk.Key uses / expected useUsed in medical devices

I’m 59 and have CFS due to PCOS. Contracting the cold virus affects my ability to clean and feed myself effectively. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

I fully support the changes for astodrimer sodium because if I get a cold I cannot work

I am a General Practitioner.

I strongly support the proposal for Astodrimer sodium being available OTC as a nasal spray.

I agree with all of the applicant's reasons for the proposal (as summarised in the Pre-meeting Public Notice document).

Many of my patients are looking for something else (in addition to vaccines and other preventive measures such as hand hygiene and masks) that may reduce their risk of contracting respiratory viruses.
Also, many people seek something that may reduce their viral load and possibly, therefore, reduce transmission of respiratory viruses to others.

None of my patients who have expressed interest in this product (which currently is very difficult to obtain in Australia) have said they would use this instead of vaccination or other protective measures, but have said they would use it as an additional protective measure.

The pre-clinical testing of Astodrimer Sodium against respiratory viruses is impressive and its claimed mechanism of action - to block the virus in the nasal mucosa and reduce the chance of contracting respiratory viruses and reduce viral load and, therefore, transmission - is very plausible. Its broad antiviral action is also very attractive, especially as many respiratory viruses have no available vaccine against them available and viruses mutate which can affect the efficacy of available vaccines.

I agree with the applicants statements that allowing over the counter availability of astrodrimer sodium in a nasal spray formulation is of very low risk to consumers and to the public. In addition to the statements made by the applicant regarding safety, this antiviral nasal spray appeals to me, as a general practitioner, as it is not an antiseptic / bactericidal agent, nor an antibiotic and so is very unlikely to adversely impact the nasal and upper respiratory tract flora (unlike some other antiviral nasal sprays under development or already in use) which could be an unintended harmful consequence of using some antiviral nasal sprays.

I very strongly support the proposal for astodrimer sodium barrier nasal sprays. This product is widely available across the world except for Australia. I strongly value anything to help reduce incidence of the cold virus as I am badly effected when I get colds and this severely impacts my capacity to maintain my employment.

I respectfully urge the TGA to approve the sale and distribution of Astodrimer sodium in Australia for the following reasons:

1/ Proven safety profile - this substance has been approved for use in many countries around the world with few side effects being reported.

2/ Proven efficacy - the use of this substance has been shown to reduce the risk of infection for many airborne diseases.

3/ Australia is falling behind the rest of the world in not having effective anti-viral nasal sprays available.

4/ Airborne diseases of many kinds bring significant suffering to thousands of people every day and having prophylactics available would reduce this impost.

5/ Economic benefits would ensue by having fewer people succumb to contagious airborne viruses and thus needing time off work. Absenteeism is a major problem for industry and staff shortages are very common. If this issue is not addressed, Australian productivity will suffer. Anything that can reduce the chance of sickness could help this problem.

6/ In the case of COVID-19, not everyone is suitable for vaccinations and wearing of masks is not popular. Anti-virals are only available to a select few and the majority of patients do not qualify. Therefore, a nasal spray that reduces the chance of catching COVID-19 or any other airborne disease represents another layer of protection available to the young, the elderly or those who are disabled with a cognitive impairment which makes the wearing of masks unsuitable.

I write this as someone employed in the field of education. My job is high-risk and my health has suffered severely since contracting COVID. An early retirement from a job that I love remains a distinct possibility. Teacher shortages are at an all-time high and fill-in staff to cover for sick colleagues are often unavailable. The cost to the students of having a disrupted education bodes ill for the future of our youth.

I have no affiliation with any company associated with this product. I merely want the best outcome for the Australian people.

I therefore implore the TGA to consider this proposal on its merits and to approve the sale and distribution of Astodrimer sodium in Australia.

Thank you for your consideration of this matter.

I would like to have access to this product to use and purchase locally because it offers excellent protection from respiratory viruses which has significant impact to my ability to work and care for my family.

I STRONGLY SUPPORT the amendment to schedule 3 for astrodrimer sodium barrier nasal sprays.

Getting colds affects my ability to work effectively. I strongly support the proposal to make this product available

I've just lost 100s of $$ trying to buy this from a fraudulent supplier in Cambodia.
And I was forced into this situation because a product developed in Australia with my tax $$ isn't approved for sale here.
It's been available in dozens of other countries for 2 years. It's got few side effects & works extremely well.
I'm in a high risk category for catching covid & will do whatever I can to reduce the risk.
Why do I have to deal with foreign fraudsters to buy an Australian product? At exorbitant prices, if at all?
This is ridiculous!
It's safe. Effective. And SHPULD be accessible to Australians.
Please approve ASAP.

Why do I have to get friends overseas to buy this for me & then pay to import it?
I've been able to stay covid free using this spray in the workplace all year.
It's very effective.
Many colleagues have become unwell with all kinds of infections.
I haven't even had a runny nose.
This is an Australian product.
It's absurd I can buy it here.
It's been safely used for 2 years all over the world. Why not here?
Please approve ASAP.

Please please allow with the ingredient Astodrimer Sodium to be sold in Australia. The company making is Australian and we should all be supporting them. Being immune compromised I want to use this along with my boosters and masks
Please please think of vulnerable Australian that can benefit from this product

Contracting the cold virus affects my ability to work effectively as well as my husband’s. We also have two children at school who are regularly exposed to respiratory viruses that interfere with their school attendance & academic progression. I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays.

I STRONGLY SUPPORT the amendment to Schedule 3 for astodrimer sodium barrier nasal sprays. I use other nasal sprays for protection agains the cold virus when out in public, particularly when travelling. I believe they are effective and would like to see an Australian-developed version made available in Australia.

Given places previously deemed 'essential' are no longer safely accessible for the medically vulnerable and disabled community, Astodrimer Sodium should be made available to the general public as another tool in the fight against COVID19 and other AIRBORNE pathogens.

I work in a hospitality environment where I am exposed to seasonal viruses, and for many people in positions like mine there is a need for a safe and effective antiviral nasal spray which can help prevent catching common cold and other respiratory viruses and also I understand this product aids in reducing symptoms quickly in the event of catching a cold.

I would love for would become available in Australia. I would be keen to use it to reduce the risk of getting COVID-19.

Fully Support proposal for Astrodrimer Sodium

As a young person who suffers from lingering heart issues after one omicron covid infection I am very interested in avoiding any further infections. In addition to the benefits to my own health I also believe that supporting the proposal for Astodrimer sodium will help the economy. I had to take 6 months off work to somewhat recover from the heart issues which covid caused me. The long covid inquiry conducted by the government demonstrated the economic impacts of long covid on various industries. Nasal sprays such as containing Astodrimer solution can help reduce the burden of covid and long covid on the economy if it helps halt infections. Finally, it is in the interest of Australians to be able to support Australian businesses such as , especially when other countries with similarly stringent regulations (such as those in the European Economic Area (EEA) have already approved it.

With respect to s 52E of the THERAPEUTIC GOODS ACT 1989 the benefits far outweigh the risks of such a product, there is an extremely low potential for abuse of the substance, and it is of low toxicity.

Expand

and ⚠️redacted⚠️ was so obvious. The only redaction I laughed at was “Jane Halton” whose report went to the Minister. Did that really need redacting

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