Sputnik V- The reasons underpinning WHO approval hesitancy 

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There must be a rationale underpinning the WHO recommendation that medicine evaluation be both apolitical and autonomous. Indeed, such a rationale is self-evident but if clarity of reasoning is opaque, a reminder is reposed in Trump’s attempts at intermeddling with America’s Covid vaccines evaluation.

In fact, a repetition of Trump’s medicine evaluation trespassing wasn’t envisaged to be in our lifetime, but for PPP tomfoolery, such wasn’t to be. For inserted they did of Dr. Ramsammy, deeper than a colonoscope, into their vaccination evaluation. And obvious it soon became that hopelessly bewildered and shockingly incapable he is, of contributing an iota of sense to the PPP intellectually impoverished medicine evaluating. And the consequence was an irreversibly hopeless vaccine evaluation, compounded by his pharmaceutical illiteracy, which surely didn’t preclude him making determinations on matters of vaccines. But certainly irremediably it became, with his most brainless of assertion that PPP evaluated Sputnik-V data, for which WHO retorted that unless PPP has divine powers to perfectly assemble a puzzle of incomplete pieces, only then can they analyse Sputnik-V incomplete data. Then most presumptuously he affirmed that PPP peer-reviewed the BMJ and Lancet articles. But hilariously hilarious that was, for aware we are that PPP would labour to spell peer-review even if aided by phonics, much-less undertake one. Notwithstanding PPP evaluation proclamation, an interrogation of the Lancet publishing history on vaccines research, is surely germane.

Dr. Andrew Wakefield controversy   

The British academic, Dr. Andrew Wakefield‘s 1998 research, purported a link between the MMR vaccine and autism. And so consequential was his work that many in academia attempted, without success, to reproduce his findings. Inevitably, suspicion aroused about his research, which was subsequently discredited as fraudulent. Thereupon, Dr. Wakefield was erased from the medical register and the Lancet retracted his article, but the damage was already done, as millions of children were denied MMR vaccination, leading to measles epidemics.

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BMJ

And it’s against this backdrop that PPP purported to have sourced the BMJ and Lancet, to inform their Sputnik-V evaluation. But dubious is their methodology, that an elucidating deconstruction of their evaluation, by way of critically appraising the aforementioned articles and BMJ report, is requisite. Indeed, from the outset, the BMJ report uncovered inconsistencies in each of the three phases of the Sputnik-V trials. Significantly, in Phases-1&2, vaccine efficacies were consistently found to be all the same, which the Lancet attributed to coincidence, small sample size and the discrete distribution of outcomes.

To put this another way, if 90% of the Grade VI candidates at each examination centre, were to all score 600 marks at the Grade VI examination, would arouse suspicion. Nonetheless, Phase-3 trials are of larger sample sizes, hence variance is anticipated. But this wasn’t the case, as once again vaccine efficacy was all the same, this time between age groups. In fact, similarly excessive identical vaccine efficacy, was identified in earlier interim analyses and subsequent published article, outlined below,

“On 11 November 2020, a first press release announced a 92 % efficacy. From this press release we can compute that there were four Covid cases in the vaccine group and 16 in the placebo group. On 24 November 2020, a second press release announced a 91% efficacy with 8/14,095 cases in the vaccine group and 31/4,699 in the placebo group. On 14 December 2020 a third press release announced again a 91% efficacy with 16/17,032 cases in the vaccine group and 62/5,682 in the placebo group. Much to our surprise, the number of cases was exactly twice the number of cases observed in the previous press release in both the placebo and the vaccine groups and about fourfold the number of cases in the vaccine and placebo groups in the first press release.

Lastly, the Lancet publication, with a database lock on 24/11/2020, announced a 92% efficacy with 16/14,964 cases in the vaccine group and 62/4,902 in the placebo group. Altogether these results again appear “too good to be true”. The ratio of the number of events between the placebo and vaccine groups is as homogeneous as can be permitted by the number of events in the press releases.”

Notably, the data represented a pattern, vis-a-vis Covid cases in the vaccine groups were 4, 8,16, with subsequent numerical result being twice the antecedent. In the placebo cohort, cases were 16, 31, 62 with the subsequent numerical being also being twice the antecedent. But such can occur, even though very unlikely, by random chance, for which P-values can illuminate. Again the BMJ;

“The unusual and improbable high homogeneity of the vaccine efficacy across age strata and different interim analyses raises concerns about the data reported.”  Indeed, these higher than usual identical results, placed Sputnik-V results into question, for which the BMJ expressed concerns to the Lancet, of outcome: “In a recent letter to The Lancet documenting these concerns, the editorial team agreed to publish the letter on condition that we removed our concerns on the press release results since these results were not part of the Lancet publication. We, however felt it important to forward our concerns to the European Medicine Agency which we did on 03/12/2021. The recent BMJ publication by Baraniuk C highlights the phase-3 data but did not address these concerns. We therefore felt it pertinent to inform readers of also these concerns with the Sputnik V vaccine data.”

Conclusion: The European Medicine Agency likely informed WHO, impacting Sputnik-V WHO approval.

The Lancet  

Clinical trials are of three phases, hence published data should reflect this. However, this Sputnik-V research article addressed only Phase-3 trials.

To that end, Phase-3 trials recruited 21,977 adults where 16,501 were randomly assigned to the vaccine group and 5476 to the placebo group. Subsequently, 19,866 received two doses of vaccine or placebo and were included in the primary outcome analysis. But from tabulations, of the 21,977 participants recruited to the Phase-3 trials, only 19,866 were accounted for with the other 2,212 unaccounted for.

Then on day-21 post-first vaccine dose,16 of 14 964 participants in the vaccine group and 62 of 4902 in the placebo group were confirmed to developed COVID-19. Calculated vaccine efficacy of 91·6%

Conflict of interest: Moscow City Health Department, Russian Direct Investment Fund, and Sberbank provided funding.

Conclusion  

Critically appraisal mandates a structured approach which may follow the IMRAD mnemonic format of Introduction, Method, Results and Discussion, which are then sequentially critically examined. Do the numbers add up? Do the results make sense? Are the analyses consistent? Is there missing data? Is there conflict of interest?

With all things considered, the findings are concerning. Phases-1&2 data missing, inconsistent data, unusual high data homogeneity, unaccounted for participants, conflict of interest etc. And likely, this may explain WHO protracted wait, for the missing Sputnik-V data.

Notwithstanding the fact that journal articles aren’t recognised for medicine approvals, it would’ve been impossible for PPP to evaluate Sputnik-V with incomplete trial data along with the aforementioned articles. This brings into question, not only the 200% price tag but also the fantastical approval. Furthermore, with only incomplete data available for Sputnik-V, it would’ve also been impossible for the Guyana Medical Council to undertake any analysis, therefore their reported analysis is likely fraudulent.



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