Recent new reports have exposed the subtle and not-so-subtle maneuvers of various governments to “bend the rules a little bit” in the process of certifying the efficacity and safety of the novel vaccines against the SARS-CoV-2 virus infection. Given that the vaccines, unlike the therapeutic products, will be administered to, not only people who are free of the disease, but also to individuals that are very vulnerable. After months of terrible suffering and thousands of deaths, Humankind cannot afford to make the mistake of using a vaccine that is either defective or not properly useful.
Three vaccine candidates – the ones designed by Pfizer, Moderna and Astra-Zeneca – are already well into the Phase 3 clinical trials, the last step before applying for regulatory approval by the Food and Drug Administration (FDA) and similar regulatory agencies. In a Washington Post article, Laurie McGinley and Carolyn Y. Johnson said: “A fierce debate has emerged whether the Food and Drug Administration should use its emergency authority to clear a coronavirus vaccine before it is formally approved – a move opponents warn could pose safety dangers and inflame anti-vaccination sentiment but others said could save thousands of lives by speeding protection from the virus.” On September 3rd the Centers for Disease Control and Prevention (CDC) warned the state health officials to start making preparations to distribute a coronavirus vaccine to health care workers and other high-priority groups by November 1st; that announcement immediately sparked a hot debate whether the Trump administration is actually trying to “push a vaccine” before the critical November 3rd general elections in the USA or not.
The vaccine(s) that will eventually be approved by the regulatory agencies must prove that, not only they show efficacity, but they will provide worthwhile efficacity. After the Phase 3 clinical trails show a certain degree of efficacity for a period of time, the vaccine candidates must be vetted for protection against severe forms of the disease and also enough long-term persistence of the protective effects by setting up double-blind placebo studies that might take many more months. Unfortunately, the world does not have the luxury of waiting 2,3, or even 4 years for this process.
In a comment to The Lancet Public Health, Philip Krause, Thomas R. Fleming and Ira Longini—members of the World Health Organization (WHO) Solidarity Vaccines Trial Expert Group—said: “There is a danger that political and economic pressures for the introduction of a COVID-19 vaccine could lead to widespread deployment of a vaccine that is in reality only weakly effective (eg. reducing COVID-19 incidence by only 10-20%) perhaps because a misleadingly promising result from an underpowered trial.” The massive deployment of a “weak vaccine” will have deleterious Public Health consequences for two major reasons:
- Authorities may wrongly assume that it represents the expected panacea and disburse major financial and human resources to deploy it.
- Vaccinated individuals may assume that they have the needed protection, disregarding the basic measures of protection like Social Distancing.
If the “weak vaccine” is compared to a worse under-performing candidate, we might have the bio-creep effect: the statistical programs might wrongly identify the “worse vaccine” as being non-inferior in the comparison. The WHO recommends that a successful vaccine candidate should reduce the risk of infection by at least half and with a certainty that its true vaccine efficacity is at least 30%. The Food and Drug Administration (FDA) concurs with the basic threshold of 30% to show efficacy. “As an example of a result that would just satisfy these two criteria, an even randomized trial with 50 cases arising in those vaccinated and 100 cases in those given placebo would have a 95% CI that just excludes 30%, but would suggest 50% short-term efficacy.”
The authors argue that a global multi-vaccine trial with a shared control group might provide faster and more reliable results about their safety and efficacity. High enrollment rates of individuals for the clinical trials and the participation of many clinical centers worldwide might hasten the discovery and delivery of a candidate. Evaluation of safety in multi-vaccine trials might unmask certain adverse effects in some candidates that might not be present in the rest. One of the greatest risks for any vaccine is its potential to worsen the disease in certain groups, which might only be evident with a critically large number of participants over a larger period of time.
Spurious commercial and political interests have blocked the initiative of a multi-vaccine trial as the parties are keeping guard over “their” vaccines and are reluctant to share scientific and operational data with competitors and other governments. Sadly, Humankind has not yet succeeded in overcoming these pitiful petty interests.
Stay distant. Stay safe. Stay beautiful.
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