Showing posts with label vaccines. Show all posts
Showing posts with label vaccines. Show all posts

Wednesday, 11 January 2023

Review of COVID-19 Vaccine and Treatment Purchasing and Procurement aka the Halton Report is very clear about the fact that the world & Australia are not yet 'COVID-stable'. That federal and state governments need to revisit public heath and vaccine procurement policy & planning.


 

Transcript of letter accompanying Review of COVID-19 Vaccine and Treatment Purchasing and Procurement report:



The Hon Mark Butler

Minister for Health and Aged Care

Parliament House

CANBERRA ACT 2600


Dear Minister


On 30 June 2022 you commissioned an independent review of the purchasing and procurement of COVID-19 vaccine and treatments to inform the next 12-24 months. This report provides the conclusions and recommendations of the review.


The review team engaged with a number of key stakeholders involved in Australia’s response to the

COVID-19 pandemic and rollout of vaccines and treatments. This included epidemiological experts

both nationally and internationally, Commonwealth, state and territory Health departments and bodies, health sector organisations, as well as manufacturers of the vaccines and treatments procured within Australia.


As principal reviewer I was assisted by Professor Peter Collignon AM who provided expert medical advice. I would also like to acknowledge the work of the review project team led by Georgie Fairhall, Department of Health and Aged Care.


Early procurement of vaccines and treatments occurred in a highly competitive global market. In this context Australia secured a portfolio of effective COVID-19 vaccines and treatments enabling high rates of primary course vaccination preventing serious illness and death relative to global peers.


However, Australia and the world are not yet ‘COVID-stable’, and we are unable to confidently predict the timing or impact of new waves and variants. This uncertainty presents particular challenges. The availability of efficacious vaccines and treatments will continue to play a key role in ensuring ongoing protection for lives and livelihoods.


The next two years are critical to supporting our economy, health and education systems to recover. Australia's approach to the procurement of vaccines and treatments needs to be responsive to the changing environment and should be guided by clear policy and understanding of risk appetite.


Consideration should be given to the decision-making structures and advice required, and whether new and existing pathways for procurement and distribution of vaccines and treatments should be retained or adapted. Finally, it is critical that Australia maintains surge capacity in the event of a serious new variant or another infectious disease.


Yours sincerely


Hon. Professor Jane Halton AO PSM

19 September 2022

[my yellow highlighting]




Review of COVID-19 Vaccine and Treatment Purchasing and Procurement aka the Halton Report by clarencegirl on Scribd

https://www.scribd.com/document/618758421/Review-of-COVID-19-Vaccine-and-Treatment-Purchasing-and-Procurement-aka-the-Halton-Report


Note: This letter, executive summary & recommendations are the full extent of what the federal government was prepared to release for public consumption. The remainder of the Halton Report allegedly covers contractual arrangements with vaccine manufacturers and as such is commercial-in-confidence.


The Saturday Paper, 7 January 2023, excerpts:


A summary of the review by former senior health bureaucrat Professor Jane Halton was released in September last year. The full version of the report, obtained by The Saturday Paper under freedom of information laws, paints a disturbing picture of what could lie ahead as the virus mutates further and existing vaccines become less effective.....


Speaking to The Saturday Paper this week, Halton emphasised that the virus remains a serious threat that could worsen. 


“The world is currently seeing the emergence of yet more new variants, including XBB1.5, which underscores that the pandemic and particularly the effects of SARS-CoV-2 are not yet completely behind us,” said Halton, who heads the global Centre for Epidemic Preparedness Innovations, or CEPI. 


“It’s really important to take a step back and say, ‘What are we trying to achieve here?’ I’d love to see a narrative from the federal Health minister – the goals we want to achieve. I’m just not seeing that. It just seems to be a lot of Whac-A-Mole going on.” 


“The entire world is looking forward to a day where we don’t have to worry about SARS-CoV-2. However, we continue to need to be prepared for all circumstances, including new and more dangerous variants.” 


In her report, Halton writes that Australia signed advanced purchasing agreements (APAs) with vaccine manufacturers “later than other comparative countries which delayed the supply of vaccines and the speed of the rollout”. 


Australia later overtook other countries, once a distribution plan was in place. However, Halton warns that those foundational APAs are now expiring. “As a consequence, new APAs giving effect to purchasing decisions will be needed.” 


A spokesperson for Butler declined to comment specifically on new purchasing agreements but said the government “has ensured there is a portfolio of vaccines and supply available to Australians in 2023 and 2024”. 


The report says the new government should rethink eligibility for both vaccines and the antiviral treatments that lessen the virus’s impact on individuals. It says optimising their uptake and investing in new versions will be “critical” in what will continue to be a highly competitive global market. 


“In the short-term, wider eligibility for some treatments should be considered where there are stocks available, there is evidence of efficacy, safety and broader economic and societal benefits (such as workforce availability). This is particularly the case where there is no significant private market to help limit the burden of the disease.” 


The absence of a “private market” highlights that the government’s approach to Covid-19 vaccines is different than for other vaccines. 


For example, anyone in Australia can access the annual influenza vaccine. The government lists the vaccine on the Pharmaceutical Benefits Scheme (PBS) and identifies priority groups who can receive it free. Others who want to be vaccinated protectively can pay to obtain it through vaccination clinics or their local general practice. Some employers offer staff vaccinations to limit workdays lost to illness. 


That is not the case for Covid-19 vaccines and was also not the case for Covid treatments when they first became available. The government is the only purchaser and distributor of these vaccines and it alone controls who can access them. 


Unlike its American counterpart, the Australian government has only authorised a fifth vaccine dose for the most vulnerable. In the United States, a protective fifth shot is widely available. 


Butler’s spokesperson did not respond directly to a question about the different approaches to eligibility. “New booster dose recommendations are anticipated in early 2023 in preparation for winter,” they said. “Future recommendations will aim to provide ongoing clear guidance across all groups including time since last dose and definitions of eligibility.” 


The current, restrictive approach was adopted in the pandemic’s emergency phase to ensure access was not dictated by who could pay; but Halton notes circumstances have now changed, with most of the population protected by at least basic vaccination. 


She suggests that widening access to vaccines – and treatments – could slow the spread of variants and lessen risk as immunity wanes. In other words, the cost-benefit equation around restricting access has shifted. 


Halton writes that variants influence the effectiveness of both vaccines and treatments. “These changes are significant for decision-making,” she writes, “and the relative benefit of individual vaccines and treatments will continue to need to be assessed.” 


The report also indicates a shift in the importance of antiviral treatments, which have not been a focus in Australia’s Covid policy. Halton notes that if vaccination or previous infection no longer offer significant protection against new variants, treatments may now be considered proportionally more beneficial than when protection from vaccines was higher.


Halton warns that the current broad distribution framework for vaccines “does not include a strategy for the distribution of treatments as they were not widely available in 2020”...... 


Halton’s report says strategies and frameworks drafted early in the pandemic are now out of date and don’t adequately consider developments in vaccines and especially treatments for the virus. She says government should rethink those restrictions put in place because of supply constraints.....


She also notes that because the previous government elected to adopt all advice from the Australian Technical Advisory Group on Immunisation (ATAGI), it effectively became the decision-maker. Its advice was not always interrogated and was portrayed as entirely clinical when it was sometimes based on judgement.


The ATAGI advice, which is released publicly, is often treated as prescriptive and rules-based. The timeliness of this advice has also been questioned.”


Halton describes a “mismatch” between vaccine supply and demand, the latter having been restricted by the eligibility criteria ATAGI had applied, which were often narrower than those contained in the Therapeutic Goods Administration approvals. Halton says this has created confusion about their respective roles.


She writes that ATAGI’s advice “has changed over time and does not provide a firm foundation for procurement decisions”.


Halton’s report says there have also been delays in the booster stage.


While Australia has had early success with managing the pandemic, further emergence of new variants and management of the vaccination rollout has seen waning performance in comparison to other countries,” the report says. “Australia currently has the second lowest rate of booster uptake among comparator countries.”


Halton says “inconsistent messaging from health authorities” has contributed to the slow booster uptake and urges the government to significantly improve public communications.


The government has accepted all of Halton’s recommendations “in principle”, Butler’s spokesperson said. A formal government response is expected soon.


Wednesday, 1 December 2021

Entering December 2021 and the origins & nature of the Omicron Variant are as clear as mud. Global concern mounts. Australia's total number of Omicron cases stands at 6 people



IMAGE: ALJAZERRA, 30 November 2021













Just two days ago Scott Morrison stood in front of the cameras:


Prime Minister, Deputy Prime Minister, Minister for Infrastructure, Minister for Infrastructure, Transport and Regional Development, Minister for Foreign Affairs, Minister for Women, Minister for Health and Aged Care, Minister for Home Affairs, Joint Media Statement, 29 November 2021, excerpt:


On the basis of medical advice provided by the Chief Medical Officer of Australia, Professor Paul Kelly, the National Security Committee has taken the necessary and temporary decision to pause the next step to safely reopen Australia to international skilled and student cohorts, as well as humanitarian, working holiday maker and provisional family visa holders from 1 December until 15 December.


The reopening to travellers from Japan and the Republic of Korea will also be paused until 15 December.


The temporary pause will ensure Australia can gather the information we need to better understand the Omicron variant, including the efficacy of the vaccine, the range of illness, including if it may generate more mild symptoms, and the level of transmission.


Australia’s border is already closed to travellers except fully vaccinated Australian citizens, permanent residents and immediate family, as well as fully vaccinated green lane travellers from New Zealand and Singapore and limited exemptions.


All arrivals to Australia also require a negative PCR test and to complete Australian traveller declaration forms detailing their vaccination status and confirming requirements to comply with state and territory public health requirements…..


New Zealand currently has a LEVEL 4 (RED) Travel Advisory Alert on Australia warning that if its citizens travel they may have difficulty with being allowed back into New Zealand at a future date and, since 8 November 2021 Singapore has allowed fully vaccinated travellers from Australia to enter Singapore without quarantine, for all purposes of travel.


It is possible that both countries may temporarily close their borders to Australia if community transmission of the Omicron Variant begins in New South Wales.


However, as a suspicion grows around the world that the Omicron Variant has been 'in the wild' for much longer than originally suspected and its community transmission masked by cases being misdiagnosed as Delta Variant, border closures at this stage are thought unlikely to keep SARS-CoV-2 Omicron Variant out of a country. Rather such closures might at this point only slow down the international mobility of this variant.


Then there is this.....


Reuters, 30 November 2021:


SYDNEY, Nov 30 (Reuters) - The head of drugmaker Moderna (MRNA.O) said COVID-19 vaccines are unlikely to be as effective against the Omicron variant of the coronavirus as they have been previously, sparking fresh worry in financial markets about the trajectory of the pandemic.


"There is no world, I think, where (the effectiveness) is the same level . . . we had with Delta," Moderna Chief Executive Stéphane Bancel told the Financial Times in an interview.


"I think it's going to be a material drop. I just don't know how much because we need to wait for the data. But all the scientists I've talked to . . . are like 'this is not going to be good.'"


Vaccine resistance could lead to more sickness and hospitalisations and prolong the pandemic, and his comments triggered selling in growth-exposed assets like oil, stocks and the Australian dollar.


Bancel added that the high number of mutations on the protein spike the virus uses to infect human cells meant it was likely the current crop of vaccines would need to be modified.


He had earlier said on CNBC that it could take months to begin shipping a vaccine that does work against Omicron.


BioNTech, Moderna and Johnson & Johnson have all begun working on vaccines that specifically target Omicron in case their existing COVID-19 vaccines are not effective against the new variant.


In Australia the Morrison Government is not yet acknowledging this situation but rather arguing about whether or not to bring forward booster shots of the COVID-19 vaccines as a way of countering Omicron Variant infection.


On 30 November 2021 Australia's total number of known SARS-CoV-2 Omicron Variant cases stood at six individuals.



BACKGROUND


World Health Organisation, WHO Director-General's opening remarks at the Special Session of the World Health Assembly - 29 November 2021, excerpt:


More than any humans in history, we have the ability to anticipate pandemics, to prepare for them, to unravel the genetics of pathogens, to detect them at their earliest stages, to prevent them spiralling into global disasters, and to respond when they do.


And yet here we are, entering the third year of the most acute health crisis in a century, and the world remains in its grip.


This pestilence – one that we can prevent, detect and treat – continues to cast a long shadow over the world.


Instead of meeting in the aftermath of the pandemic, we are meeting as a fresh wave of cases and deaths crashes into Europe, with untold and uncounted deaths around the world.


And although other regions are seeing declining or stable trends, if there’s one thing we have learned, it’s that no region, no country, no community and no individual is safe until we are all safe.


The emergence of the highly-mutated Omicron variant underlines just how perilous and precarious our situation is.


South Africa and Botswana should be thanked for detecting, sequencing and reporting this variant, not penalized.


Indeed, Omicron demonstrates just why the world needs a new accord on pandemics: our current system disincentivizes countries from alerting others to threats that will inevitably land on their shores.


We don’t yet know whether Omicron is associated with more transmission, more severe disease, more risk of reinfections, or more risk of evading vaccines. Scientists at WHO and around the world are working urgently to answer these questions.


We shouldn’t need another wake-up call; we should all be wide awake to the threat of this virus.


But Omicron’s very emergence is another reminder that although many of us might think we are done with COVID-19, it is not done with us. ……


Full speech can be read here.


World Health Organisation, 29 November 2021:


Risk Assessment

Given mutations that may confer immune escape potential and possibly transmissibility advantage, the likelihood of potential further spread of Omicron at the global level is high.

Depending on these characteristics, there could be future surges of COVID‐19, which could have severe consequences, depending on a number of factors including where surges may take place. The overall global risk related to the new VOC Omicron is assessed as very high. 


Friday, 29 January 2021

Uncertainty continues over Australian rollout dates for COVID-19 mass vaccinations



The Sydney Morning Herald, 27 January 2020:


Australia’s vaccine rollout plan is under a cloud after the European Union slapped export controls on COVID-19 vaccines produced within their territory, including the Pfizer and AstraZeneca jabs the Morrison government is relying on.


The controls, which effectively mean vaccine producers must ask for permission before shipping vials outside the region, will at the very least slow the distribution process for countries outside Europe. 


A spokesman for Health Minister Greg Hunt did not answer specific questions about what the European decision means for Australia’s vaccine rollout. Australia has ordered 10 million doses of the Pfizer vaccine, which is being manufactured in Belgium. The first shipment of at least 80,000 doses is due by the end of February.


On ABC News on 25 January 2021, Pfizer Australia Managing Director Anne Harris says surging demand for the Pfizer vaccine around the world has delayed the rollout of the vaccination program in Australia. She is anticipating that there will be a two week delay so the Pfizer vaccine will not arrive until later in February at the earliest.


Bloomberg, 26 January 2021:


European Union regulators proposed requiring drugmakers to flag exports of coronavirus vaccines in advance as the bloc seeks to step up inoculations amid growing anger about delivery delays by AstraZeneca Plc, which faces a fresh grilling at mid-week. 


The proposed “transparency mechanism” for vaccine exports comes after the European Commission expressed “deep dissatisfaction” with a disclosure by Astra that planned deliveries of its Covid-19 vaccine would face delays. The EU’s executive arm says that this would mean significantly fewer deliveries of the jab this quarter than what was foreseen in the advance purchase agreement struck between the two sides last summer.....


The federal government's phased rollout plan is that the vaccines will initially be available at between 30-50 hospitals around the country, with exact locations yet to be confirmed. Then the rollout will be extended to est. 1,000 locations, including GP practices, dedicated vaccine clinics and community health centres. Residential aged care and disability care facilities will be delivered doses to be injected into residents and staff on-site.


The rollout is intended to cover 25.7 million people.


In Phase 1a quarantine and border staff, frontline health workers, aged care and disability staff and residents, will receive the Pfizer-BioNTech vaccine. Up to 1.4 million doses expected to be available.


Phase 1b will see anyone aged over 70, Aboriginal and Torres Strait Islander people who are over 55, other healthcare workers, younger adults with an underlying condition and high-risk workers will receive a vaccine - likely to be the AstraZeneca vaccine. Up to 14.8 million doses expected to be available.


Phase 2a covers Aboriginal and Torres Strait Islander people who are between 18-54 years of age, along with others in the population over 50 years old and other critical high-risk workers. Up to 15.8 million doses expected to be available.


Phase 2b is the rest of the adult population, plus anyone from the previous phases that have been missed out. Up to 16 million doses expected to be available.


Phase 3 will see child vaccination but only, but only if medically recommended. Up to 13 million does expected to be available.


NOTE: It is unclear whether the term "dose" is for the preliminary first dose of the two-dose vaccines or refers to the total vaccination per person. As other government documents mention an expectation of acquiring over 104.8 million doses of these two COVID-19 vaccines in 2021, it would appear it is likely the first dose which is mentioned in the three phases. 


UPDATE


The Guardian reported on 29 January 2021 that due to supply issues AstraZeneca is unable to meet the Morrison Government's initial order of 3.8 million doses of its vaccine and the order has been reduced to 1.2 million doses. At this stage Australia's order of 10 million vaccine doses from Pfizer remains unchanged.