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Where disinformation is evident, silence is never an option. For this is the undertaking of this column; serving the dual purpose of transforming Dr. Leslie Ramsammy disinformation, while concurrently scrutinising PPP phantom Medicine Approval Body, utilising International Best Practises as the gold standard.
Infectious diseases have been a perennial threat to humankind, evident in the extended period they led all caused mortality. But with the passage of time the threat diminished on account of vaccines, with cardiovascular diseases prior to Covid, leading mortality indices. Also observable with the passage of time was the inverse relationship between vaccinable infections and vaccine technology, dating back to the 10th century smallpox variolation to present day mRNA. But despite the aforementioned, our vaccination programme primary endpoints of decrease deaths and cases, are way off target. As a matter of fact, six weeks into our programme, Covid deaths and cases continue along the ghastly trajectory of exponentially increases.
Vaccines in PPP begging bowl
Oxford-AstraZeneca pioneered by the Oxford University was developed on the principle of multiplying nonfunctional chimpanzee adenovirus that serve as the carrier of the coronavirus spike protein. And with Oxford-AstraZeneca counting in our limited repository of Covid vaccines, remarkably it is the only one to have undergone rigorous clinical efficacy and safety trials. But more remarkably, it is the only vaccine in our repertoire to have undergone independent analysis, as per International Best Practise.
Also in our vaccine repertoire are the Covaxin and SinoPharm vaccines, developed from dead coronavirus. But unfortunately these vaccines haven’t been independently analysed for the want of clinical data.
Medicines approval, articulated ad nauseam throughout this pandemic, is an evidence-based process inform by the safety and efficacy data. And this approval process may lead to either; application rejection or approval on a full or emergency basis, dependent on the application. But full approval by it’s nature of being protracted doesn’t lend itself to a pandemic emergency while the abbreviated but thorough emergency approval is much more suited.
Universally, health practises are guided by evidence-based International Best Practises which for medicine approvals recommend undertaking by an autonomous regulatory body of competent medical specialists. This serves to preclude political interferences impacting objectivity as was evident with ex-President Trump and the FDA.
Additionally, International Best Practises recommends that medicine approval should be informed by efficacy and safety data from clinical trials. For the process is guided by a risk-benefit analysis; wherefore if risks outweigh benefits, tilts the outcome to no approval. On the other hand, if benefits outweigh risks then approval is likely.
PPP Phantom Vaccine Approval
For our three Covid vaccines, AstraZeneca counts as is the only one with multiple emergency approvals from countries with transparent approval processes, hence mandates no further assessment by us.
In contrast, SinoPharm and Covaxin are without clinical data along with a non-transparent and politically driven approval process in their countries of origins, as a result mandates our assessment. Having said that, in the absence of clinical data, which are the cornerstone of medical approval, it will be impossible to assess any of these two vaccines as was evident in their failed international and WHO approvals.
Dr. Leslie Ramsammy in a letter to the editor claimed that Covaxin and Sinopharm were provided emergency approval by the Government. For without doubt, Dr. Ramsammy claim is impossible on two levels. Firstly, International Best Practises recommends that the approval of medicines, inclusive of vaccines, should be undertaken by an autonomous independent regulatory body as described earlier. Secondly, in the absence of clinically tested data, it would be impossible to objectively assess Covaxin and Sinopharm, for emergency approval. Surely pursuing this impossible absent data vaccine approval is not dissimilar to an attempted eligibility assessment of a Grade 6 student for QC but lacking any data on his test scores apart from his parents’ vociferous claims that he is very smart; not unalike the Chinese Ambassador endorsement of the Chinese SinoPharm vaccine to the gullible PPP.
Therefore, the PPP announcement of their world first medicine approval without data, certainly must be seen for what it is; yet another instalment of their political piffle, with Dr. Leslie Ramsammy, another of the four useless de facto Ministers of Health, being the incompetent conduit.
Cause or coincidence?
Oxford-AstraZeneca is presently in the spotlight, bringing to the fore the limitations of clinical trials in identifying all potential side-effects associated with medicines. And these limitations stem from the nature of clinical trials which undertake testing with thousands of volunteers but on approval, the medicine is administered to hundreds of millions which increases the likelihood of revealing rarer adverse effects. But it must be stressed that not all suspected adverse reactions are medicine related; for in the case of AstraZeneca, there are questions of increased blood clots risk. The fact is, blood clots are common therefore it is likely that someone vaccinated with Oxford-AstraZeneca can coincidentally develop blood clots, unrelated to the vaccine. Regardless, the determination of causation or association is required, which mandates that Oxford-AstraZeneca data be independently interrogated to ascertain if the vaccination cohort has higher rates of blood clots compared to the general population. So far, this doesn’t appears to be the case based on Oxford-AstraZeneca data which revealed that after 17m vaccinations, there were only 37 cases of blood clots. Surely, these small numbers cannot justify the suspension of Oxford-AstraZeneca use when thousands are dying daily from Covid.
Vaccination dead end.
Israel has led the way in Covid vaccination and in so doing were the first to recognise that even in the early stages of the vaccination programme, there was demonstrable decreases in deaths and new infections. Indeed, these findings were replicated in other countries including, USA, the UK, Canada ect.
And the underpinning science is, the vulnerable were first vaccinated as a priority. Additionally, vaccination creates the phenomenon of ‘dead end host’ which speaks to infected persons inability to infect others because of their immunity from vaccination.Therefore, the result is a reduction in cases and deaths by virtue of decreased infections. As a result, it is concerning that after six weeks, we have not had similar reductions in our cases and deaths. The fact that this is not the case or demonstrating any indication of being the case, begs the question of why, with possible reasons including;
1. All three vaccines are infective: This is unlikely based on AstraZeneca clinical trial data.
2. Covaxin and SinoPharm are both ineffective: This is likely in the absence of clinical data.
3. A non-clinically driven vaccination process is being undertaken.
4. The variants are contributing to the increase cases and deaths: A distinct possibility with the high variants mortality in Brazil. Further, AstraZeneca has reduced efficacy against the variants but notably Covaxin and SinoPharm did not test against the variants but are likely to have zero efficacy.
5. PPP not enforcing face-mask use after vaccination
Our continued exponential increases in Covid deaths and cases, despite six weeks into the vaccination programme, is very concerning. Surely, the aetiology is likely to be multifactorial with an interplay of the deadly variants, ineffective Covaxin and SinoPharm vaccines along with absent enforcement of face-mask use after vaccination.