We’re publishing today a piece by retired Pharmaceutical Research and Development Scientist Dr. John D. Flack, who is appalled that the gene-technology vaccines now being used for COVID-19 were not subject to the standard safety studies usually required for novel genetic-based medicines. Dr. Flack, a member of HART, was involved in pharmaceutical research throughout his career and served as Director of Safety Evaluation for a pharmaceutical company, so when it comes to safety studies of new drugs he knows what’s he’s talking about. Here’s an excerpt:
It seems to me that the regulatory authorities may have considered this new class of medicine as a vaccine and followed the toxicology guidelines for conventional vaccines. But as discussed above, they are not vaccines in the conventional sense. They are injections of a laboratory synthesised gene sequence – what in previous decades we would have called a new chemical entity (NCE). Furthermore, they are being given, not as a single dose, but because of their limited efficacy as repeated injections – called boosters. On the hoof, it seems, it is decided that extra doses must be given. How can this possibly be unless supported by the appropriate safety studies? And how convenient for the worldwide authorities regulating the approval of new medicines that the Centers for Disease Control (CDC) in the USA modified the definitions of vaccine and vaccination – to allow for the new “ways in which vaccines can be administered” – to embrace this new technology that would be previously classed as an NCE. Sorry, but simply changing the definition of the term vaccine to fit the properties of these novel injections doesn’t obviate the need to conduct the appropriate studies by which their safety can properly be assessed. That is why I use the term vaccine in quotation marks or simply describe them as injections.
So how would I design a package of studies to assess the safety of these novel ‘vaccines’?
Here is a list of preclinical toxicology studies that in my view should have been performed before regulatory authorities gave their approval to the licensing of these novel therapies under the Government emergency powers:
1. Acute toxicity assessment in rodents and possibly pigs to assess the local and intramuscular irritancy. The pig is a very good model for assessing human muscle irritancy.
2. A 14 day repeat-dose study in two animal species at three different dose levels of the active moiety i.e., the spike protein. The objective of these studies would be to achieve a no effect dose level and to identify those organs in the body that would be adversely affected at high doses. In other words, establish the potential target organs of toxicity in the clinical setting.
3. Pharmacology studies in appropriate animal species to establish any possible adverse effects on the normal functioning of the body vital organs. Emphasis being paid on the cardiovascular and blood systems as these had been clearly established as targets of the SARS-CoV-2 virus through the spike protein and its known attachment to angiotensin converting enzyme 2 (ACE2) receptors in exerting its pathological effects.
4. Pharmacokinetic studies to establish the distribution of the gene sequence to other parts of the body following intramuscular injection of the gene sequence and the concentrations of spike protein in the blood after intramuscular injection.
These would have been the minimum of studies carried out prior to any trials in humans. The data from these studies would determine whether there was a sufficient margin of difference between the dose giving rise to the beneficial immunogenic effect and that causing any adverse effects to justify proceeding with clinical trials. In other words, determine the ‘therapeutic ratio’. As discussed above, this ratio would need to be high considering the medicine would be given to healthy people not patients with disease, when the ratio can be much smaller.
Worth reading in full.