but some positives
This week all of us that have been looking at COVID data are in a state of shock/confusion/sadness. The US committees have approved the Emergency Use Authorisation (EUA) for the Pfizer and Moderna vaccines for children ages 6 months to 5 years. The lack of justifying evidence is astounding. I’ll provide some discussion on this.
On a positive note we saw an interview on the Epoch Times with Professor Gigi Foster this week. She is a Professor of Economics at University of NSW, one of the main universities in Sydney. She has been outspoken on the harms caused by the pandemic measures. It’s really worth watching the full interview that can be found here (you may need to register an account). She has done a cost benefit analysis of the lockdowns:
“we calculate that lockdowns are about 30 or 35 times more costly than what they could possibly have delivered in benefits…
and we’re starting to see new networks for the provision of mental health support. For example, in Australia, our resistance group has somebody who has started up such a thing to help people who have been damaged by the COVID policies, because their standard therapists aren’t even going to admit that could possibly have been the case. So they can’t speak freely. Right? They’re not allowed to feel bad about the fact that they were withheld from school for two years or whatever, right? It has to be, oh, you were doing this for your grandmother. Let’s talk about the real problem. No, the real problem is I couldn’t go to school for two years. You took me out of my normal development enhancing experiences for two years, and now I’m depressed or anxious or suicidal, whatever it is.
So to be able to have those open discussions, you need a network of mental health professionals who allow you to speak freely.”
The interview was a breath of fresh air. The group think in Australia is endemic but it’s heartening to know we still have some free-thinking academics and there is therefore some hope. Jan Jekielek is the interviewer. I like his interview style and find his way of questioning very good.
I believe this is the sort of top level analysis that needs to be done. We spent billions of dollars in Australia for people to sit at home while the country was locked down. We put small businesses out of work and delayed education. Those billions of dollars are money not going to be spent on hospitals or healthcare services in the future. Money is not infinite and the printing presses will eventually slow down. Lack of resources will directly lead to deaths in the future, while the pandemic measures seemed righteous in the short term.
In other Australian news we had a public holiday weekend, last weekend. This celebrates the Queen’s Birthday (even though it’s not her birthday). National awards are handed out - the Order of Australia. Several health bureaucrats, highly paid, responsible for the COVID health response, were amongst the list of highest awards.
It’s what you would expect.
Australia is getting mentioned internationally (see this Igor Chudov substack post) in the context of endless infections. We are experiencing an early flu season in Australia. Many people seem to getting flu badly and it is strangely lasting up to 10 days for some. It’s being called “Australian Flu”. An Australian newspaper article coverage is here.
Children COVID Vaccine Approval
The FDA trials report for the Pfizer COVID vaccine for children 6 months to 4 years can be found here.
It is hard to see what the benefit would be for children. There’s almost no point trying to do a detailed analysis. There are summaries here (2 minute video) from Dr Clair Craig of the HART group (Health Advisory & Recovery Team. UK doctors, scientists, economists, psychologists and academics) and here.
Vinay Prasad is a hematologist-oncologist and Associate Professor in the Department of Epidemiology and Biostatistics at the University of California San Francisco. His summary is in a video on his substack here.
He explains that it is impossible to have a trial endpoint based on severe disease or death using trials with such small numbers. It may take a trial of hundreds of thousands to a million children to have an appropriately powered trial. However, he believes the onus should still be on the companies, making billions of dollars out of the products, and the regulators to force them to do these trials. He makes this point strongly in many of his videos. There is no excuse not to do the trials properly.
Also the children who participated in these initial trials, ie children of parents running out to get the vaccine as soon as possible, are from a different demographic to the average children that would get the vaccines once approved. He describes the trial participants as generally wealthy people, living in liberal enclaves. See the anecdote at about 5 min 50 in the video of child, age 3 ,who has never been to the grocery store due to the parents fear of COVID. He clarifies the risk very well.
Vinay Prasad picks up on the effect of the type of trial participants very well in his analysis of other aspects of the COVID-19 vaccines. In this post on studies of effectiveness of the 4th shot he shows inconsistencies, where the cohort getting the 4th shot are clearly different to others. Effects are observed for the 4th shot cohort before the vaccine could even possibly have had an effect. The person that runs out for the 4th shot is very different to the average person. So these type of trials are biased.
Also summaries from Alex Berenson and Steve Kirsch. Robert Malone notes in his substack that the number of deaths of children due to COVID in the US is less than occurs for typical influenza and even less than occurred for the H1N1 pandemic of 2009-10. The majority of the deaths were children with other severe illnesses. On the authorisation he writes : “Frankly, this is shocking. So shocking, it is hard for me to even write about it.”
Listening to one of the FDA panel members responsible for making the decision, he wanted note made that parents need to understand the risk and benefit. He notes that only 442 children under 5 have died from/with COVID in the US. In other words he acknowledges that the risk is low for children in this age group. He compared it to the risk of anyone being struck by lightning (the age-old comparison) which is a similar risk ratio. All the FDA panel committee members voted for approval regardless.
Robert F Kennedy (in a short video in this tweet) provides his take on the legal reasons why it is important for the pharmaceutical companies to obtain the EUA approval for the COVID vaccine in children. He explains that if the vaccine is eventually formally approved, ie not just emergency use, and it is also considered a childhood vaccine this extends the liability protection. I believe he is saying that if the vaccines were formally approved for use and they are not considered childhood vaccines then the manufacturers do have liability.
My take, from the report:
See the first table for children 6 months to 2 years The calculated Efficacy, last column, is useless, even negative, until after 3 doses.
Child vaccination therefore potentially makes a child more likely to catch COVID after the first injection. We know in adults there is a period of immune system suppression after first injections. A final reported Efficacy of 75.5% is based on 1 child catching COVID after 3 shots in the vaccine group and 2 children catching COVID in the placebo group (noting the placebo group was half the size of vaccine group).
The Confidence interval goes down to -370% at the bottom end! What this means is that we can’t rule out that in another trial set of data like this that the vaccinated children, under 2, are three times more likely to be infected!!!
Criteria were set in the trial for what is considered severe COVID. More children ended up with severe COVID in the vaccine arm, ie six, versus one in the placebo arm.
Six children were removed from the trial due to adverse events in the vaccine arm and one in the placebo arm. This broke down as follows: for the 6 months to 23 months group it was 3 in vaccine group, 0 placebo group; for 2 years to 5 years, 3 in vaccine group, 1 in placebo group.
So severe COVID was worse and adverse events were worse in the vaccine group than for the placebo group.
I can’t see anything encouraging with this data. I understand that approval was not based solely on this data but some other contrived criteria involving antibody levels and comparing that to adults. I think Igor Chudov summed it up best in his substack with a letter written to his children, apologising for not looking into the performance of all the other childhood vaccines that he went along with assuming they were safe and effective.
I recall around 10 years ago (2010) there were many adverse events in children with a flu vaccine in Australia (1 in 100 children having febrile convulsions and a reported death). The vaccine was soon withdrawn for use in this under 5 age group. I found a couple of relevant articles about the episode. From the British Medical Journal abstract (article behind paywall). Other BMJ abstracts here and here criticising the Australian response and an article on ethical issues raised at the time due to industry interference. Also articles from Australian legacy media and the Parliamentary enquiry.
What got my attention at the time, was that it came out that the vaccine had only been tested on a very small number of children in this age group before being rolled out to them. I recall the number was so small I was shocked. At the time I was fully engaged in the medical device industry, developing test systems for an implantable device, and the detail we went into with our test systems, to make sure as far as possible things worked as intended, was intense. One therefore just assumed that these things we stick in our body are similarly sufficiently tested.
If this is the level of scientific oversight that leads to approval and release of these vaccines we have to question everything that has been done by medical regulatory authorities.
If the COVID vaccine is mandated for children in order to attend pre-school then some parents will elect to subject their children to it, based on convenience and not really understanding the risk to benefit ratio they are accepting.
The ultimate danger is mandates.