Alexander: "Et tu Dr. Peter Marks? You too, lowing FDA vaccine efficacy threshold standards below 50% because you cannot reach the FDA's threshold? Your own threshold, so you reduce it." DANGEROUS!
by Paul Alexander
Et tu Dr. Peter Marks? You too, lowing FDA vaccine efficacy threshold standards below 50%?
Why the rush, Dr. Marks? Why would you drop the threshold of 50% that the FDA itself set? This stretches the imagination as to why at this time. I have always argued that the 50% threshold was arbitrary and had no sound scientific underpinning and should have been raised. You are saying if the children vaccine is less effective, you will still authorize. Would you drop the threshold to 15%? Say 5%? How low? Why even have a threshold if you can just summarily discount it? We are getting reports that Pfizer and Moderna are actually not even meeting the low 50% threshold so your reaction is to reduce the cut-point threshold? How alarming! “If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize,” Marks said.
How frightening is this that the FDA would lower the threshold of 50% (lower boundary of 30%) and not move to meet the standard or even raise the standard to engender confidence by the public. You should be raising the standard, not lowering it. We are talking about our children. Some are arguing that the rush to authorize the children’s vaccines is to maintain liability protection (no ability to sue for loss once approved for children) and also, once the children vaccine is approved in full, then adults could have access. I am not conversant on these issues but if any of this is only 1% true, then this is very very duplicitous and troubling.
The public already has near zero trust in the vaccine developers or the FDA especially given the players have been absolved of liability under the March 2020 PREP Act. Why then this aggressive yet substandard move on the FDA’s part? You as the COVID vaccine regulator Czar, function as the key regulator and your role is to safeguard the population and as such, your signaling of a lowered benchmark is cause for concern. We know that the baseline risk (control) for COVID infection and illness is near statistical zero in children so you will need a massive sample size to detect an effect. Is that even possible and again, the baseline risk is near zero. How could you reduce the risk below zero?
We know how low the risk is in children in the first place and we know that as of February 2022, approximately 75% of children and adolescents had serologic evidence of previous infection with SARS-CoV-2, with approximately one third becoming newly seropositive since December 2021. So why the need for this vaccine when most and I argue it is more akin to 100%, are immune in some manner? Thus, the vaccine developers Pfizer and Moderna have their work cut out for them for they are facing a near 100% immunity in children and a near zero risk of illness or death in children, with a vaccine that is on record causing severe harms and deaths, even in teens and children. Moreover, we are facing the infectious omicron subvariants (BA.2, BA.4, BA.5 etc. with more to come due to continued use of a non-sterilizing vaccine that does not cut the chain of transmission and thus causes natural selection pressure on the virus’s infectiousness (spike protein)). In addition, this is not the initial legacy Wuhan strain. The vaccine does not even hit the spike with a clear mismatch. The vaccine carries toxicity (any drug or vaccine or medical device) along with known risks such as myocarditis. With all of that, why move to use these problematic, ineffective and not properly safety tested vaccines on our children?
Children are more than likely already COVID-recovered and also would have some prior cross-protection from prior coronavirus exposure. With no benefit in young healthy children yet with potential for harm, then parents would be far better off avoiding the unnecessary and more certain harm for a modest or non-existent benefit. Overall, I argue there is no need for these vaccines in healthy children yet Pfizer’s Bourla and Moderna’s Bancel press on, with multiple FDA authorization meetings set in June. We know that the FDA is engaging in a shock and awe campaign to push these vaccines out onto the public, without the public really having time to digest the flurry of your whirlwind June (VRBPAC) 2020 meeting agenda. We have to insist that Dr. Marks does not lower the standard of 50% and instead raises it given this is our children. We must stand up as parents and say that unless liability protection is removed, then we will not consider these injections. We will not even discuss it until liability protection is removed.
The truth is that parents are very scared, very concerned about these COVID genetic injections and to have Peter Marks playing around with the already low 50% threshold the FDA itself set, is cause for serious concern. Parents are very adept and schooled on COVID and know that COVID is mild for the vast majority of persons who get infected and the vast majority recover and do very well. absolutely do not want the government technocrats and bureaucrats dictating and mandating that they must vaccinate their child when they the parents know that healthy children do not get severely ill or die from COVID, and that their natural innate immune systems (1st line of immune defense) handle the virus superbly. COVID has spared our children, unlike seasonal influenza, and parents understand this full well. They also know that these genetic platforms can have substantial side effects and the vaccinal antibodies are not matched to the omicron variant spike protein. Parents are fully aware now that the injections do not stop infection, replication, or transmission, and critically, does not sterilize the virus (non-neutralizing antibodies). The injections have essentially failed on omicron and are not properly safe and parents are adept, they know. Importantly, parents know that no healthy child in the US has died due to COVID. COVID is not severe or does not kill healthy children (death, if there is death, is more than likely with COVID than from COVID). We saw this also in places like Sweden and Germany.
To close, no one thus far, has prosecuted the case as to why low risk healthy children need these injections and as such, we must fight against it. You the vaccine companies and the FDA have not proven to us the public, why these injections were needed, effective, or safe. It is your responsibility, not ours! The burden is on you!