World governments, including our own, have been adding to the confusion around COVID-19 vaccines with misinformation and changing facts, writes Sue Arnold.
THE LEVEL OF CONFUSION and misinformation associated with the Delta pandemic cannot be entirely shafted on social media and conspiracy devotees.
Australia is providing an excellent example of how a pandemic can be politicised as the line is drawn between supporting the economy and/or coping politically with bursting hospitals, exponentially increasing mortality and endless lockdowns.
‘...the curfews in south-western and western Sydney have not worked and were introduced only following media pressure.’
The Federal Government has also demonstrated an outrageous lack of responsibility in failing to adequately plan, provide and ensure the nation is equipped to deal with a pandemic that has turned the world upside down.
It’s not as if the governments haven’t had time to get a proper plan together.
No country has found an easy solution. Many are suffering from a backlash with deadly wars over masks, social distancing and vaccines accompanied by soaring hospitalisation and death rates.
Are the messages from governments only stoking the fires?
According to the press release by Greg Hunt, Minister for Health and Aged Care, dated 8 August 2021, the Federal Government has secured an initial shipment of over 7,700 doses of the novel antibody treatment sotrovimab. This treatment has been shown to dramatically reduce hospitalisation and risk of death in adults with mild to moderate COVID-19 who are at risk of developing it severely.
According to Hunt’s press release, the sotrovimab treatment has been shown to reduce hospitalisation or death by a whopping 79% in mild-to-moderate COVID-19 cases at high risk of progression to serious COVID-19.
Just one dose is required, administered by an IV infusion in a health care facility.
The UK Government’s medicines regulator approved the treatment in mid-August.
In the USA, the Food and Drug Administration (FDA) approved the emergency use of monoclonal antibodies for the treatment of COVID-19 in November 2020.
In Australia, the Therapeutic Goods Administration (TGA) is assessing the treatment. No information is available on when the treatment might be approved. According to the TGA website, a provisional approval pathway allows for the temporary registration of promising new medicines and vaccines where the need for early access outweighs the risks.
The provisional registration is for an initial period of two years. The pathway to full registration takes up to a maximum of six years.
Under the heading ‘Provisional Registrations’, the TGA identifies the effective date for AstraZeneca as 15 February 2021.
There are no emergency use authorisations available in Australia. No information is currently available as to when the monoclonal antibody treatment will be accessible.
Another question on the backburner relates to an explanation of the major differences between the FDA emergency approvals, the UK medicine regulator and Australia’s TGA assessments.
The FDA is the oldest and most influential regulator in the world. It was set up, according to an article in The Guardian, to safeguard consumers. The FDA demands all the raw data from the lab, animal and human trials and does its own statistical analysis.
Nothing is taken on trust. More than 43,000 people were involved in the final trials of the mRNA vaccine developed by Pfizer and Moderna.
If the FDA stringent emergency approvals are not good enough for Australia, what are the standards the TGA is using? Why are there no emergency use provisions?
Given the abject failures of the Morrison Government to deal with the pandemic, is there a case for bringing in a regulation that provides for TGA emergency use?
There’s also confusion over vaccine information based on ever-changing versions of so-called scientific facts.
AstraZeneca is a good start. Some time ago, when only AstraZeneca was available, patients were told to wait for 12 weeks before having a second shot. According to the medical spiel, it would take that amount of time for the antibodies to be at optimum efficacy in providing protection.
The Federal Government’s expert vaccine panel recommended in July that people who’ve had their AstraZeneca jab are advised to wait 12 weeks before getting their second dose.
According to the article, the Australian Technical Advisory Group on Immunisation (ATAGI) recommended a minimum wait of four weeks in line with research that showed a 12-week wait between doses provided optimal protection.
A study in The Lancet found receiving a second dose 12 weeks or more after the first can kick up protection to around 81%. This efficacy dropped to around 55% if the second jab was given less than six weeks after the first, according to the study.
Authorities in Victoria have now said that the second AstraZeneca jab can be given from six weeks rather than after three months.
“There’s an urgent need to get vaccinated right now, as soon as possible, because we need to control this.”
Is it any wonder the public is confused?
The burning layman’s question is this: If the time between doses is reduced to four weeks, which according to the latest data drops efficacy down to around 55%, does this mean breakthrough infections are more likely?
Does it mean that people who have had a second jab at four weeks are protected for a shorter period of time? Should people who’ve had the second jab at four weeks get a booster shot given the downgrading of efficacy?
And what about the next variant?
According to an article in the Sydney Morning Herald, the Mu variant has been found in 49 U.S. states and four dozen countries:
‘Health officials believe Mu is even more transmissible than the Delta variant and has the potential to resist vaccines.’
The lack of leadership in the federal and NSW Governments does not engender any faith that the next potential pandemic tsunami will be responsibly handled.
Add the growing “anti-mask, my freedom's at stake” cult to the mix and the results are not promising.
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