COVID Questions submitted to federal Department of Health
I submitted the following Questions on Notice to the federal Department of Health during the most recent Senate Estimates (end June 2021). I’ll update this page with their response and answers when I receive them.
As of 11th September, some answers are available for public viewing, as stated below.
1. Why can’t rapid testing be used at aged care centres, hospitals etc. for entering workers to try and reduce outbreaks of COVID-19?
A: On 9 October 2020, the Public Health Laboratory Network (PHLN) and the Communicable Diseases Network Australia (CDNA) (expert standing committees of the Australian Health Protection Principal Committee) published a joint statement on the use of rapid antigen tests. The Statement notes that rapid antigen tests may have a role as a screening test for COVID-19 in certain contexts and settings, to be determined by jurisdictional public health authorities. Importantly, the use of rapid antigen tests would be complementary to, and not a replacement for, RT-PCR testing. Their use must also be considered in line with the Testing Framework for COVID-19 in Australia, which describes the epidemiological contexts in which rapid antigen tests may be appropriate for use. Some industry groups are in discussion with states and territories and the Commonwealth to determine whether rapid antigen tests have a role in detecting presumptive COVID-19 cases, when used in conjunction with PCR tests and other public health measures, in certain high risk settings. The role of the Commonwealth Government is to approve rapid antigen tests for supply in Australia through the Therapeutic Goods Administration. PHLN and CDNA, advice is provided on appropriate use.
2. Was it wise for the Labor Opposition to compromise safety by putting pressure on the TGA to roll out the vaccine before the TGA approved it?
A: The TGA acts independently at all times in order to fulfil its mandate of stringently assessing the safety and efficacy of medicines.
3. Given Swine Flu had a median death rate of 48 and Covid has a median death rate of around 80 plus, why are governments reacting differently now to how they reacted to Swine Flu in 2009 regarding lockdowns, quarantining and vaccinations?
A: Swine flu (H1N1) was a novel influenza A and COVID-19 is a novel coronavirus. These are two very different types of viruses and have distinct viral characteristics, necessitating different responses to protect the Australian population.
The H1N1 virus associated with the 2009 ‘Swine flu’ pandemic was less transmissible, associated with milder disease, and had a lower case fatality rate, with an estimated 284,000 (151,700 – 575,400) total deaths worldwide during the first 12 months of virus circulation in each country. Conversely, SARS-CoV-2 has a higher case fatality rate, and is associated with more severe disease (particularly in older populations). As at 15 June 2021, there have been over 3.8 million deaths from COVID-19 worldwide, with an estimated two million deaths occurring within the first 12 months.
As the 2009 H1N1 ‘Swine Flu’ pandemic was the second known H1N1 pandemic in history (the first being the 1918 Spanish flu), there was at least some population immunity in certain population cohorts (those >60 years old) that protected against severe disease. This is why, unlike seasonal influenza, the 2009 H1N1 pandemic primarily affected younger population groups.
As the 2009 H1N1 pandemic was caused by an influenza virus, there were known pharmacological options for management (namely anti-viral medications) which reduced length of hospital stay, and reduced the risk of progression to severe disease. Vaccine development processes were already established, allowing a vaccine to be very quickly developed. Mass vaccination was able to begin in some countries only five months after the first cases were detected, reducing transmission and the severity of the (already less severe than COVID-19) disease.
Conversely, the entire population was initially susceptible to SARS-CoV-2, there were/are no known pharmacological options for management of COVID-19, and there were no pre-existing vaccines that could be modified for SARS-CoV-2, meaning a new vaccine had to be developed. In the absence of immunity, prophylactic or therapeutic/management options, given the high morbidity and mortality associated with COVID-19, public health interventions such as lockdowns and quarantine were, and are still necessary to reduce the risk of importation of SARS-CoV-2 and protect the Australian population from high levels of morbidity and mortality.
4. Should deaths when people had comorbidities be counted as COVID-19 deaths or comorbidities? I note the Health Department in my prior QoN quoted 91% of people who died from COVID-19 in ICU had comorbidities and a median age of 86.
A: The COVID-19 Communicable Diseases Network Australia (CDNA) Series of National Guidelines for Public Health Units states that a COVID-19 death is defined for surveillance purposes as a death in a probable or confirmed COVID-19 case, unless there is a clear alternative cause of death that cannot be related to COVID-19 (e.g. trauma). There should be no period of complete recovery from COVID-19 between illness and death. Where a coroner’s report is available, these findings are to be observed. For example, if a person is acutely experiencing a COVID-19 infection and during this time they suffer a heart attack and suddenly die, then their death would be reported as a COVID-19 death if it is determined that the COVID-19 infection triggered the heart attack. Attributing the acute cause of death in the context of underlying comorbid chronic conditions is determined clinically on a case by case basis and if someone is experiencing an acute COVID-19 infection that exacerbates an underlying medical condition, then it would still be reported as a COVID-19 death as the COVID-19 infection was the immediate cause of their death despite underlying conditions. Usually on the death certificate there is space to list underlying conditions a person had in the time period in the lead up to their death. There are a number of checks and balances at a medical professional level when signing death certificates. Doctors are professionally trained to attribute death especially in circumstances where there is no ambiguity as to why someone has died based on their clinical history. In the event there is significant doubt around the cause of death, and, the nature of how someone died meets criteria at a state and territory level for automatic referral to the Coroner then the Coroner legally signs off on the cause of death after further forensic investigation. Once the death is recorded then this is entered (de-identified) in our public health surveillance systems where epidemiologists analyse the data further to ensure there is no misclassification before it is collated for public reporting. Based on sentinel hospital surveillance data, from 27 February 2020 to 25 April 2021, 84 per cent of COVID-19 cases who died in an intensive care unit (ICU), and where comorbidity data was available, had at least one comorbidity.1 This includes chronic respiratory conditions, cardiac disease (excluding hypertension), immunosuppressive condition/therapy, diabetes, obesity, liver disease, renal disease and neurological disorder. The age of those who died in ICU with no comorbidities ranged from 42 to 81 years. A detailed table on COVID-19 comorbidities can be found in Table 9 of the COVID-19 in Australia: Epidemiology Report 40, at: https://doi.org/10.33321/cdi.2021.45.25
5. Does mask prevention depend on the quality of mask? If so, which masks should or should not be used?
A: The Infection Control Expert Group (ICEG) provides advice on the type of mask to be worn in certain circumstances. Advice for on the use of personal protective equipment (PPE) for health care workers in the context of COVID-19 has recently been updated and is available on the Department of Health’s website. PPE is a critical part of infection prevention and control. However, it should be considered as the last line of defence within a broader ‘Hierarchy of Controls’ framework. This includes implementing measures to minimise the risk of the virus spreading, for instance isolating cases and ensuring workplace practices are COVID-safe. Non-sterile face masks (including respirators) that are intended, by their manufacturer, to prevent the transmission of diseases between people, or are intended to be used in a healthcare environment, are medical devices. Masks identified as medical devices are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989.
6. Has the Australian Red Cross taken serology tests on blood taken in Q4 2019 to determine if Covid was in the community at that time?
A: The Australian Red Cross Lifeblood has been an active participant in national and targeted sero-surveys of population immunity to SARS-COV2 to inform clinical and public health responses. These seroprevalence surveys are undertaken by the Australian Partnership for Preparedness Research on Infectious Disease Emergencies (APPRISE), which is funded by the National Health and Medical Research Council, and for the national survey funding was also provided by the Department of Health (Health). These serosurveys have used donated blood collected during the first phase of the pandemic (up to August, 2020). It is understood these surveys have not tested donor blood samples from quarter 4 of the 2019 calendar year. However, the Australian Red Cross Lifeblood has advised that it has retrieved and stored about 2,000 specimens from donors who donated during this period in case such testing is required. Results from the Sydney survey were published in the Medical Journal of Australia? and with analyses from the national serosurvey being finalised. Serosurveillance is one of the key surveillance approaches adopted as part of the Australian National Disease Surveillance Plan for COVID-19, which has been endorsed by the Communicable Diseases Network Australia, with the objective of understanding population level protection. As part of the national serosurvey, Health has sought advice from APPRISE regarding future serosurvey options, including identification of the most suitable SARS -CoV-2-specific antibody test, and is currently considering future serosurveys requirements.
7. What percentage of the population need to be vaccinated before state governments stop closing borders and locking down residents? i.e. what percentage would achieve herd immunity?
A: There is no set percentage at which herd immunity is achieved. Even at relatively high vaccination rates, modelling has shown that herd immunity may not be achieved against more transmissible variants of COVID-19. However, modelling has shown that increasing vaccination, coupled with intermittent public health measures can effectively reduce the spread of COVID-19. States and territories continue to have primary operational responsibility for public health and emergency response measures within their respective jurisdictions, such as lockdowns and border restrictions, under their public health legislation. On 6 August 2021, National Cabinet agreed to a four-step National Plan to transition Australia’s COVID-19 response. The National Plan provides a graduated pathway to transition Australia’s COVID-19 response from its current pre-vaccination settings focused on continued suppression of community transmission, to post-vaccination settings focused on public health management of COVID-19, consistent with other infectious diseases. The National Plan will move between phases once Australia reaches key vaccination thresholds – moving to Phase B once 70 per cent of the Australian population 16 years of age and older is fully vaccinated and Phase C once 80 per cent of the population is fully vaccinated.
8. What is the normal number of trials a drug or vaccine have to go through before being approved for use? i.e. Phase 1 trials, Phase 2 etc.
A: Before a drug or vaccine is registered for use, it is tested extensively during its development and then in thousands of individuals via clinical trials. For instance, tens of thousands of individuals participated in the Phase II/III and Phase III clinical trials for the AstraZeneca and Pfizer COVID-19 vaccines:
o AstraZeneca: two phase III clinical trials submitted to the Therapeutic Goods Administration (TGA) for evaluation followed approximately 10,300 and 12,390 participants respectively (see: www.tga.gov.au/auspar/auspar-chadox1-s).
o Pfizer: the phase II/III clinical trial submitted to the TGA for evaluation followed 44,000 participants (see: www.tga.gov.au/auspar/auspar-bnt162b2-mrna)
9.1 Has the AstraZeneca or Pfizer vaccines gone through the standard testing or have they been fast tracked? (see next answer)
9.2. If fast tracked, what testing was avoided? (see next answer)
9.3. When did testing on these vaccines begin and how many trials were undertaken? (see next answer)
• The Therapeutic Goods Administration (TGA) is responsible for assessing all vaccines (including those being developed for COVID-19) before they can be used in Australia, and vaccines are only registered if the benefits greatly outweigh the risks.
• The AstraZeneca and Pfizer COVID-19 vaccines have been fully scrutinised by the TGA in accordance with all ordinary processes to ensure compliance with strict standards of safety, quality and efficacy.
• COVID-19 vaccine applications are being treated with the greatest priority so resources were redirected to their evaluation and testing as quickly as possible without any compromise to the process.
• COVID-19 vaccines are being assessed under the ‘provisional approval’ pathway.
• To receive provisional registration, the TGA must establish the safety and efficacy of the vaccine based on preliminary clinical data. This includes demonstrating that the benefit of early availability of the vaccine outweighs any inherent risks associated with the fact that additional data is still required.
• The TGA has made a full and thorough assessment of the data which includes clinical studies, non-clinical and toxicology studies, as well as chemistry, and manufacturing information for the Pfizer and AstraZeneca COVID-19 vaccines.
• The clinical trials conducted for the AstraZeneca and Pfizer COVID-19 vaccines and independently assessed by the TGA are given in the publicly available Product Information (PI) on the TGA website:
o https://tga-search.clients.funnelback.com/s/search.html?query=COMIRNATY+BNT162b2+& collection=tga-artg (Pfizer) o tga-search.clients.funnelback.com/s/search.html?query=AstraZeneca+ChAdOx1- S&collection=tga-artg&profile=record (AstraZeneca)
• The TGA engaged early with pharmaceutical companies about their vaccines and is accepting, or has accepted, rolling data. This means that the TGA can assess clinical trial data as it becomes available, rather than at the end of the three clinical trial phases. This speeds up the review process without compromising on our strict standards of safety, quality, and efficacy.
• Once approved, the TGA undertakes an independent quality assessment of every batch of vaccine supplied in Australia. Therefore, no testing was avoided.
10.1. The Pfizer vaccine is a mRNA vaccine that delivers a genetic code to produce a spike protein and the AstraZeneca vaccine is a recombinant vaccine that puts the code for the spike protein into a complete different virus, both with the aim of stimulating an immune response. Is this correct? (see next answer)
10.2. How long have these methods been used for therapeutic purposes? (see next answer)
A: For COVID-19, there are four main categories of vaccines in clinical trials: whole virus, protein subunit, viral vector and nucleic acid (e.g., mRNA). Each type of vaccine is designed to teach the body’s immune system to safely recognise and block the virus which causes COVID-19. The Pfizer vaccine is classified as a messenger RNA (mRNA) vaccine or ribonucleic acid (RNA) vaccine, while the AstraZeneca vaccine is a viral vector vaccine. Descriptions of the type of vaccines and how they work are publicly available on various websites, including: Australian Government Department of Health, at: www.health.gov.au/initiatives
11. The original form of the influenza vaccine developed in the 1960s and still in widespread use delivered the whole virus (rather than just a spike protein), which has been weakened or killed, and then allowed the body to recognise and respond to it. Is this correct?
• Inactivated (killed) whole virus influenza vaccines have been available since the 1930s.
• Live attenuated (i.e. weakened) influenza vaccines were also developed in the 1930s and have been used since the 1950s to protect humans against seasonal influenza.
• However, all influenza vaccines currently supplied in Australia for public use are inactivated surface antigen vaccines, or inactivated split virion vaccines, rather than inactivated or live attenuated whole virus vaccines.
12.1. The traditional vaccines given for measles, mumps, rubella, chickenpox etc. contain a weakened version of a germ that causes a disease. Is it correct that the mRNA and AZ vaccines use different methods than those vaccines that most people get as a child? (see next answer)
12.2. How long are the vaccines effective for? Could studies please be cited? (see next answer)
A: Inactivated vaccines use a killed version of a germ, while live attenuated vaccines use a weakened version of a germ. There are no inactivated or live attenuated vaccines for COVID-19 approved for use in Australia by the Therapeutic Goods Administration (TGA). The Pfizer and Moderna vaccines use an mRNA platform. The AstraZeneca vaccine is a viral vector vaccine. These vaccines contain a segment DNA or MRNA that leads to the recipient making a small portion only of virus, against which the immune response is formed. Research is still ongoing to determine how long COVID-19 vaccines will provide protection for an individual, and the degree of efficacy that is maintained. In April 2021, Pfizer announced data ahead of publication from their ongoing Phase 3 trial that showed that there was at least six months protection against symptomatic COVID-19 observed for the Pfizer vaccine, retaining 91.3 per cent efficacy. In May 2021, it was reported that the AstraZeneca vaccine works well as a third booster dose, although data from any studies has not yet been released. Further study results for Pfizer and AstraZeneca are expected as the global roll out continues.
13.1. Will the population need to be revaccinated on a regular basis? (see next answer)
13.2. If so, how often? (see next answer)
A: The Australian Government continues to meet with vaccine manufacturers and monitor international developments to determine if revaccination is likely to be required for ongoing immune response. Vaccine manufacturers are investigating options to provide boosters, with some targeting specific variants of concerns, and others looking to use a booster dose of their current vaccination.
14. To what percentage do vaccines stop transmission? Could studies please be cited.
A: The primary purpose of COVID-19 vaccines is to prevent individuals from severe disease and death from the SARS-CoV-2 virus. Both the AstraZeneca and Pfizer vaccines provide significant protection against symptomatic disease. There is evidence that in addition to substantially reducing severe disease, vaccination also results in a significant reduction in the chance of transmitting the virus to others. In March 2021, Public Health Scotland reported preliminary results of a study of over 140,000 households of healthcare workers who had received at least one dose of Pfizer or AstraZeneca. Those who were vaccinated and became infected with SARS-CoV-2 were 30–54 per cent less likely to pass the SARS-CoV-2 virus onto their household members, compared to transmission from unvaccinated healthcare workers. In April 2021, Public Health England reported preliminary results of a large study of COVID-19 transmission involving more than 365,000 households in the UK with a mix of vaccinated and unvaccinated members. Individuals who tested positive to COVID-19, but had been immunised with one dose of either the Pfizer or AstraZeneca COVID-19 vaccine, had a reduced likelihood of infecting others by 40–50 per cent compared to transmission rates from unvaccinated individuals.
15. To what extent has new variants reduced vaccine efficacy?
16. Has testing of the vaccine be performed on people with arrhythmia or hemolysis? If not, given the clotting that’s occurring, would it be wise to do so?
For the AstraZeneca vaccine:
• Clinical trial data submitted to the TGA to support registration of the vaccine included participants with irregular heartbeat (arrhythmia) or haemolysis. However, the clinical trials were not designed to assess participants with arrhythmia or haemolysis specifically.
• Given that the clinical trial data already included trial participants with irregular heart beat (arrhythmia) or haemolysis, and with the current very low rate of clotting adverse events after immunisation with this vaccine, it would be challenging to design a clinical trial to investigate these rare events. However, there are studies ongoing to better understand the exact mechanism of clotting condition such as Thrombosis with Thrombocytopenia Syndrome (TTS).
For Pfizer vaccine:
• The clinical trial data submitted to the TGA to support registration of this vaccine did not specifically identify study participants with arrhythmias or haemolysis.
• No clotting adverse events have been reported in association with the Pfizer vaccine, so a clinical trial to investigate clotting is not required at this time
17.1 In the TGA’s reporting of vaccines, 210 died after receiving the vaccine. What did these people die from – the vaccine or other comorbidities?
17.2. Has a causal relationship been established as to what these people died from?
17.3. If they died of comorbidities, why is the TGA excluding them from deaths related to the vaccine given the common practice of reporting people dying with COVID-19 as though they died from Covid?
A: Due to patient confidentiality, we are unable to provide the causes of death for individual reports of death following vaccination. Detailed investigation of the cause of death is the role of the state or territory Coroner. All deaths that are reported as possibly being linked to vaccination are included in the TGA database. The number of deaths reported in a period of time following COVID-19 vaccination is included in the TGA weekly safety report. Individual reports are reviewed by an expert team of clinical staff. This review may include gathering and considering clinical information on the patient’s current and past medical history, risk factors, and medications at the time of vaccination, as well as any tests such as pathology and clinical notes. This may also involve discussion with the relevant state and territory Health Departments, the individual’s health professional(s) and/or the coroner. In some cases the TGA seeks advice from a panel of external medical specialists and community representatives. Since the vaccine rollout, to 15 August 2021, the TGA has only found seven cases where the individuals’ death have been causally linked to the COVID-19 vaccine out 460 reports of death from the 15.3 million doses of the COVID-19 vaccines. All seven cases were linked to the COVID-19 Vaccine AstraZeneca now called Vaxzevria: six of the deaths were related to thrombosis with thrombocytopenia syndrome (TTS) and one was related to immune thrombocytopenia (ITP), both of which are very rare adverse events. For other reports of death, our review of cases and the advice of an external Vaccine Safety Investigation Group (where required) and analysis of reporting patterns does not suggest that the vaccine caused these deaths.
18. When it comes to comparing deaths from vaccines to a background death rate of the entire population, shouldn’t the bar be higher for vaccines to ensure that a causal relationship is established?
A: Each year in Australia there are about 160,000 deaths, equating to 13,300 a month or 3,050 each week. By chance, many people will experience new illnesses or die from a pre-existing condition shortly after vaccination, especially if they are elderly. To distinguish between coincidental deaths and deaths linked to the vaccine, the TGA uses data from reports of death in a number of ways. This includes review of individual reports, comparing the reported number of deaths with the expected background rate, and analysing the data on adverse events associated with reports of death to identify possible safety signals. To conduct an ‘observed versus expected analysis’, the number of expected deaths is extrapolated for the vaccinated population to determine if the rate of deaths reported exceeds that which is expected in a population of that size. To date, the observed number of deaths reported after vaccination is less than the expected number of deaths. In addition to reviewing reports of deaths, the TGA looks for patterns of adverse events which indicate a possible safety concern. This analysis includes all reports, including those with fatal outcomes. If a safety signal is identified, it is investigated further to determine if there is a causal relationship with a vaccine. Serious adverse events, including those with potentially fatal outcomes, are prioritised for review. Since the vaccine rollout, to 15 August 2021, the TGA has only found seven cases where the individuals’ death was linked to vaccination out of 15.3 million doses of the COVID-19 vaccines. All seven cases were linked to the COVID-19 Vaccine AstraZeneca now called Vaxzevria: six of the deaths were related to thrombosis with thrombocytopenia syndrome (TTS) and one was related to immune thrombocytopenia (ITP), both of which are very rare adverse events. For reports of death other than the seven cases linked to COVID-19 vaccines, our analysis and review of cases does not suggest that the COVID-19 vaccine caused these deaths. Individual reports are reviewed by an expert team of clinical staff. This review may include gathering and considering relevant clinical information on the patient’s current and past medical history, risk factors, and medications at the time of vaccination, as well as any tests such as pathology and clinical notes. Where necessary, this may also involve discussion with the relevant state and territory health departments, the individual’s health professional(s) and/or the coroner. In some cases the TGA seeks advice from a panel of external medical specialists and community representatives.
19. Are the adverse reactions recorded by the TGA reported on a voluntary basis? Will they include all reactions or only those reported?
A: There are mandatory reporting requirements in law for sponsors of medicine and vaccines (i.e. pharmaceutical companies). Sponsors are required to report serious adverse events to the TGA within 15 days of them becoming aware. In addition, sponsors must notify the TGA of serious safety issues within 72 hours. The TGA does not have mandatory reporting requirements for health professionals or consumers – these reports are made voluntarily. However, some states and territories do have mandatory reporting requirements for health professionals to notify adverse events following immunisation to their public health units and these reports are passed onto the TGA. Furthermore, the vaccination agreements struck between the Commonwealth and GPs providing vaccination services required a commitment from the GP to report all adverse events to the TGA.
20. Have the vaccines received full approval or provisional approval? If the latter, what is the difference?
A: Due to the nature of the COVID-19 pandemic, COVID-19 vaccines are eligible to apply for a provisional registration status. To receive provisional registration, the Therapeutic Goods Administration (TGA) must establish the safety and efficacy of the vaccine based on preliminary clinical data. The data is preliminary in the sense that some important information, such as the duration of protection from infection or serious illness may not yet be available. This includes demonstrating that the benefit of early availability of the vaccine outweighs any inherent risks associated with the fact that additional data is still required. Provisional registration of vaccines approved through this pathway is limited to a period of two years. The sponsor can apply for two extensions, however, up to a maximum of six years. Data from ongoing trials will be key to providing robust evidence of the longer-term data including duration of protection against COVID-19 and to support a sponsor’s application to transition their COVID-19 vaccine to full registration status. As at 23 June 2021, the following two COVID-19 vaccines have been included in the Australian Register of Therapeutic Goods (ARTG) as provisionally registered vaccines: Pfizer Australia Pty Ltd’s COMIRNATY – BNT162b2 (mRNA vaccine) AstraZeneca Pty Ltd’s COVID-19 Vaccine AstraZeneca (viral vector vaccine).
21. Is the TGA considering allowing two difference vaccines to be used simultaneously? Has sufficient testing been performed to allow this?
A: As at 22 June 2021, the Department of Health recommends that individuals receive two doses of the same COVID-19 vaccine to complete their vaccination course. The Therapeutic Goods Administration (TGA) has not received any clinical data or other evidence to demonstrate whether mixing doses of COVID-19 vaccines is safe and effective. As at 22 June 2021, there are no published international studies on the effectiveness of a combination of vaccines in preventing coronavirus infections.
22. Why doesn’t the Australian Government hold pharmaceutical companies liable for their vaccines? If the vaccines are safe, then why is their liability waived? Most companies who sell faulty products that aren’t safe are held liable, so why aren’t pharmaceutical companies?
A: All the COVID-19 vaccine supply agreements with the various manufacturers require the Commonwealth to provide an indemnity for certain liabilities that may arise, these indemnities were provided as a condition of Australia getting access to the vaccines. However, any contractual agreements with individual companies cannot stop individuals seeking to litigate, should an individual seek to do this in the future.
The Therapeutic Goods Administration (TGA) is responsible for monitoring the safety of all vaccines approved for use in Australia. The TGA closely assesses safety data prior to approval, and continue to monitor the safety of vaccines after they are registered in Australia so that any safety concerns can be detected and responded to. More information, including the TGA’s COVID-19 vaccine safety monitoring plan, can be found at: www.tga.gov.au/covid-19-vaccine-safety-monitoring-and-reporting.
23. Why are drug makers the ones who design and perform the drug testing? Isn’t this a conflict of interest? Shouldn’t an independent body who doesn’t stand to benefit financially from the drugs be the ones who do the testing?
A: Developing a medicine or vaccine is a complex process involving several stages from the initial design phase to the final testing phases, and is financed by the pharmaceutical industry (i.e. the sponsor of the medicine). Sponsors are required to comply with regulatory requirement provided at all stages of the medicine design process. This is to ensure that all research and clinical work has been conducted in an ethical manner, and that data are credible and accurate. The Therapeutic Goods Administration (TGA) does not design medicines or conduct clinical studies. However, these studies must meet TGA requirements in order for TGA to consider a medicine or vaccine for approval. The role of the TGA is to provide key independent assessment of the safety, quality and efficacy data submitted by the sponsor. This may include further testing of the medicine or vaccine and review of testing data prior to the release of the first batches of a new product. The sponsor of the medicine is required to submit a comprehensive developmental dossier application for their medicine. This dossier usually consists of clinical studies, non
24. Do drug companies pay foreign owned social media companies to regulate posts about vaccines?
A: The Department does not have information about the subject of this question.
25. Who regulates the social media companies to ensure they aren’t censoring valid information and free speech?
26. Why do some vaccines last the best part of a lifetime while the flu shot only lasts for a few months?
A: Vaccination experts recommend that everyone over six months is vaccinated annually to reduce their chance of contracting influenza. Unlike some other vaccine-preventable diseases, the influenza virus is always changing so the influenza vaccine changes too. The strains used in seasonal influenza vaccines can change from year to year depending on which viruses are predicted to circulate in each upcoming season.
27. Why can’t the CSL vaccine be used given it only resulted in false positive? Assuming it has fewer side effects than other drugs, why isn’t that the key benchmark?
28. Is the AMA affiliated with the Immunisation Coalition who along with many of its members are funded by pharmaceutical companies? If so, how can the AMA remain impartial when providing advice regarding vaccines or any other drugs for that matter?
A: The AMA is not an agency of the Health Portfolio. The question should be referred to the AMA.
29. Given the use of the AstraZeneca vaccine has been stopped or paused in other countries, why should Australians feel safe getting it?
30. Why isn’t there a standardised testing protocol for Covid – advice from the Health department says “It is a dangerous practice to try to generalise the interpretation of a pathology result across different IVDs, unless there is a formal internationally agreed reference standard for that purpose. This does not exist for SARS-COV-2 RNA detection by RT-PCR.”
1.) The following link on this website: www.health.gov.au/sites/default/files/documents/2020/03/coronavirus-covid-19- information-for-clinicians.docx says that “it should be noted that PCR tests cannot distinguish between “live” virus and non-infective RNA.” Does this mean the PCR tests can show positive results for viruses other than Covid? I also note the following comments from the WHO and I quote: “Diagnostic testing for SARS-CoV-2 states that careful interpretation of weak positive results is needed.
a.) The cycle threshold (Ct) needed to detect virus is inversely proportional to the patient’s viral load. Where test results do not correspond with the clinical presentation, a new specimen should be taken and retested using the same or different NAT technology. WHO reminds IVD users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases.
b.) This means that the probability that a person who has a positive result (SARS-CoV-2 detected) is truly infected with SARS-CoV-2 decreases as prevalence decreases, irrespective of the claimed specificity. Most PCR assays are indicated as an aid for diagnosis, therefore, health care providers must consider any result in combination with timing of sampling, specimen type, assay specifics, clinical observations, patient history, confirmed status of any contacts, and epidemiological information.”
2.) Given the inexact nature of Covid testing would it be more appropriate to report people with symptoms of Covid rather than just an arbitrary PCR figure that may include people who are asymptomatic? Noting the following information:
a.) A recent article published in The Lancet medical journal explains that PCR tests can be “positive” for up to five times longer than the time an infected person is actually infectious. They explain that up to 75 per cent of “positive” individuals are most likely post-infectious
b.) only 44 per cent of the “positive” samples using a Ct of 18 returned a viable lab culture, according to Dr. Jared Bullard, a paediatric infectious disease specialist and a current witness for the Manitoba Government.
c.) The PCR tests are not designed to detect and identify active infectious disease. Instead, it identifies genetic material, be it partial, alive, or even dead?
3.) Given the unreliability of the PCR tests should the number of Covid cases be used as a benchmark for shutting down states rather than say ICU cases.
A: The Australian Government is supported by the Australian Health Protection Principal Committee (AHPPC) and its standing committees, including the Public Health Laboratory Network (PHLN) and the Communicable Diseases Network Australia (CDNA). Together the expert members of these groups have published the Testing Framework for COVID-19 in Australia, available on the Department of Health website. This document provides a national framework to guide local approaches to testing that states and territories can apply to fit their local epidemiological context. In line with Australian national guidelines, the primary approach to identifying people with active COVID-19 infection is based on testing those with characteristic clinical symptoms and then groups that are more likely to reveal the presence of undetected community transmission. Individuals with symptomatic COVID-19 disease will display symptoms that are similar to a range of infections caused by other respiratory viruses. Therefore, testing is required to accurately report case ascertainment to public health authorities (noting it is a nationally notifiable disease) and to describe the prevalence of COVID-19 in the Australian community. Put another way, because the symptoms for COVID-19 are not specific, diagnostic testing using RT-PCR is essential to identify persons infected. PHLN has also published testing guidance for SARS-CoV-2 (the virus that causes COVID-19) which is dynamic and updated as new evidence and best practice testing methodologies and techniques are verified. The PHLN guidance can be found here at www.health.gov.au/resources/publications/phln-guidance-on-laboratory-testing-for-sars.
31. If COVID-19 debris is found in the sewerage, does this mean Covid has been in the community and people have recovered from COVID-19 without detection?
A: Fragments of the virus (SARS-CoV-2) that causes COVID-19 can be detected in wastewater. This non-infectious genetic material shed by people infected with COVID-19 can be detected for some days before the onset of symptoms or detections from clinical testing, and may persist for many weeks after recovery from COVID-19.
A detection of SARS-CoV-2 from a wastewater sample indicates that a person currently or recently infected with SARS-CoV-2 was present in the community and shedding viral particles into the sewer. It does not confirm that there is active, infectious COVID-19 at the time of detection.
Wastewater surveillance, which involves frequent sampling, can also provide information that assists in determining whether the shedding event was a transient occurrence, for example a recovering traveller ‘passing through’, or whether there is a more persistent source of shedding within the catchment. This can assist in identifying locations or facilities for further public health investigation.
Wastewater surveillance complements existing clinical surveillance methods. It does not replace clinical diagnostic methods.
32. Should positive Covid tests be reported by Ct (cycle threshold) number so that the severity of cases can be ascertained by the public?
A: In Australia, nucleic acid amplification testing (NAAT) using polymerase chain reaction (PCR) on a respiratory sample collected by a throat and bilateral deep nasal (or nasopharyngeal) swab is the gold standard test for the acute diagnosis of SARS-CoV-2 infection. This test method is very sensitive and detects nucleic acid sequences specific to the virus. During the testing process, the PCR amplifies a highly specific target region of the SARS-CoV-2 genome so that it can be detected. Each amplification reaction is known as a cycle. The cycle threshold (Ct) value of a reaction is the cycle number when the fluorescence of a PCR product can be detected above the background signal. Each PCR assay may have a different Ct value that is used for detecting SARS-CoV-2. Ct values for one In Vitro Diagnostic (IVD) Device should not be compared with Ct values from other platforms. Ct values are IVD Device dependant and require interpretation by a qualified pathologist or medical laboratory scientist. This means there is no ‘set’ Ct value to aim for across all platforms. There are also nucleic acid amplification devices used in Australia for the diagnosis of SARS-CoV-2 infection which do not record a Ct value.
33. Why did Australians trying to return to Australia from India first test positive to COVID-19 then test negative the following day? Shouldn’t there be a more accurate diagnostic tool for detecting Covid?
A: All travellers to Australia must provide evidence of a negative COVID-19 polymerase chain reaction (PCR) test result, where the test was conducted no more than 72-hours prior to the scheduled flight. Nucleic acid amplification testing (NAAT) using PCR on a respiratory sample collected by a throat and bilateral deep nasal, or nasopharyngeal swab is the gold standard test for the acute diagnosis of SARS-CoV-2 infection. This test method is very sensitive and detects nucleic acid sequences specific to the virus. PCR testing must be conducted in accordance with the manufacturer’s instructions for use and has been comprehensively validated by pathology laboratories both locally and internationally. Although PCR tests are the most accurate tests for the acute diagnosis of SARS-CoV-2, no test has 100 per cent sensitivity or specificity in all clinical circumstances. The likelihood of false positive and false negative results occurring is very low, however may occur due to:
• laboratory error, for example assigning an incorrect PCR test result to a person’s sample • sample contamination. This can affect one or many patient samples in a run
• incorrect sampling collection method undertaken resulting in poor sample quality
• off-target (non-specific) reactivity in the PCR test. It is also possible that on the day after a positive detection for SARS-CoV-2 ribonucleic acid (RNA) in a specimen, there is no detectable SARS-CoV-2 RNA in another specimen as the person’s infection resolves. In Australia, all properly accredited Australian pathology providers operate in accordance with the requirements established by the National Pathology Accreditation Advisory Council (NPAAC) and undergo accreditation assessment by the National Association of Testing Authorities, Australia in conjunction with the Royal College of Pathologists of Australasia, which assess to the NPAAC requirements and use the international standard ISO 1589 as an assessment guide. Each country has varying degrees of accreditation and regulatory oversight over in-country diagnostic laboratories and not all use the international standard ISO 1589.
34.1. Ivermectin has been given to millions of people in recent decades and has a proven safety record. Numerous peer reviewed studies based on RCT tests have shown symptom relief and rapid reductions in mortality and hospitalisation. What steps are required in order to make Ivermectin available to those Australians who wish use it, subject to doctor-patient consultation, rather than vaccines?
34.2. Who can apply to get Ivermectin approved as a prophylaxis for COVID-19 in Australia?
34.3. The National Institutes of Health (NIH) has dropped its recommendation against Ivermectin for treatment of COVID-19, and the agency now advises it can’t recommend for or against its use, leaving the decision to physicians and their patients. Why can’t Australia adopt the same approach?
34.4. Dr Tess Lawrie, consultant to the WHO, Robert Borody, Robert Clancy and numerous other health professionals are on record saying that Ivermectin is not only safe to use but is effective. Given these views, why does the National Covid Evidence Taskforce recommend against Ivermectin in consultation with an individual’s GP?
A: It is a key priority to provide all Australians with access to safe and effective COVID-19 vaccines. The Government is committed to providing a safe and effective vaccine to everyone living in Australia. The rollout and distribution of COVID – 19 vaccines will occur in line with Australia’s COVID-19 Vaccine National Rollout Strategy. The Government is working closely with the Australian Technical Advisory Group on Immunisation, the Therapeutic Goods Administration and all state and territory health departments to ensure that monitoring of COVID-19 vaccine safety is of the highest possible standard in Australia. The Government is also committed to investigating safe and effective possible treatments for SARS-CoV-2 (the virus responsible for COVID-19), and is closely monitoring worldwide research relating to treatments for patients with COVID-19. The Department of Health funds the National COVID-19 Clinical Evidence Taskforce, which is continuously identifying and analysing research on various treatments for COVID-19 in order to provide national evidence based guidelines for the clinical care of people with COVID-19 (www.covid19evidence.net.au). The recommendations and their rationale are on the taskforce website. In regards to ivermectin, the current evidence is not of sufficient quality or certainty to support its safe and effective use for the prevention or treatment of COVID-19. Despite some emerging data suggesting that ivermectin may potentially provide both prophylactic and therapeutic benefit, more robust, well-designed randomised controlled trials are still needed before ivermectin could be considered an appropriate prevention and treatment option. They have not made any recommendations for the use of ivermectin outside of properly conducted clinical trials with appropriate ethical approval.