A vaccine in 100 days; is this a sound technological advancement, or another calamity for the global population?

BY SIMONE J. SMITH

In recognition of the potential benefits associated with earlier, widespread availability of vaccines, the Coalition for Epidemic Preparedness Innovations (CEPI), articulated an aspirational goal: vaccines should be ready for initial authorization and manufacturing at scale within 100 days after the next pandemic pathogen is recognized. This goal has been widely adopted by governments throughout the world, and several vaccine developers are exploring strategies for achieving this aim.

Before we go any further, I would like to address an inaccuracy in the claim above; in recognition of the potential benefits associated with earlier, widespread availability of vaccines. Reports over the last few years will illustrate that availability of vaccines has not been beneficial in many cases. I will not expand on that in this report, but it is important to recognize propaganda, and to call it out immediately. I digress…

There have been potential strategies for compressing the vaccine-development timeline for each major step in the development process and additional steps that will be needed to move toward the 100-day goal. Substantial time savings could come from establishing more efficient phasing of preclinical activities, clinical trials, and regulatory review.

It was noted that in order to achieve this, timelines will have to be compressed requiring substantial shifts from the current development paradigm, and it must be supported by scientific advancements.

In February 2021, Prime Minister Boris Johnson announced in a press release that the development of a coronavirus vaccine in approximately 300 days was a huge and unprecedented global achievement. He stated that reducing the time to develop new vaccines for emerging diseases even further, would prevent the catastrophic health, economic and social repercussions seen in this crisis.

Now for some of us, we might see this as a great leap in technology, and advancement that we should be happy about, but I want to take a step back and look at the history of vaccine development.

According to John Hopkins University and Medicine, a typical vaccine development timeline takes 5 to 10 years, and sometimes longer, to: assess whether the vaccine is safe and efficacious in clinical trials, complete the regulatory approval processes, and manufacture sufficient quantities of vaccine doses for widespread distribution. Let’s take a look at the stages involved in the vaccine development process:

Preclinical Testing of Vaccine Candidates

Preclinical testing of vaccine candidates typically starts in animal models, first in small mammals such as mice or rats, and then non-human primates such as monkeys. Preclinical studies are important for eliminating potential vaccines that are either toxic or do not induce protective immune responses. Many vaccines that appear to be safe and induce protective immune responses in animals fail in human studies. Only vaccine candidates that are very promising in preclinical testing move forward into phase I clinical trials.

Phase I Clinical Trials to Assess Safety, Dosing, and Immune Responses

Phase I clinical trials are the first step in assessing vaccines in people. Typically involving one to several dozen healthy volunteers, phase I trials assess short-term safety (e.g., soreness at the site of injection, fever, muscle aches) and immune responses, often with different vaccine doses. Only if a vaccine candidate is shown to be safe in phase I trials will it move to larger phase II trials.

Phase II Clinical Trials to Assess Safety and Immune Responses

Phase II clinical trials continue to assess safety and immune responses, but in a larger number and more diverse group of volunteers, typically one to several hundred people. Phase II trials may include target populations of a specific age or sex, or those with underlying medical conditions. Vaccines for children start with adult volunteers and move to progressively younger groups of children. Different types of immune responses are often measured, including antibodies and cell-mediated immunity, but phase II trials do not assess how well a vaccine actually works. Only in phase III trials is vaccine efficacy assessed.

Phase III Clinical Trials to Assess Safety and Efficacy

Phase III clinical trials are critical to understanding whether vaccines are safe and effective. Phase III trials often include tens of thousands of volunteers. Participants are chosen at random to receive the vaccine or a placebo. In Phase III, participants and most of the study investigators do not know who has received the vaccine and who received the placebo. Participants are then followed to see how many in each group get the disease. Assessing short- and long-term safety is also a major goal of phase 3 trials.

I am going to stop here before we move to one of the last steps. The COVID-19 inoculation rollout did not include this final step in the sense of identifying it as safe. It was only after there were serious side effects did they start reporting them. It is safe to say that the current “vaccine” was not safe and effective and should have stopped at this stage. Unfortunately for many of our loved ones, it did not.

Let’s move to the final stage,

Regulatory Approval Process

Each country has a regulatory approval process for vaccines. In the United States, the Food and Drug Administration (FDA) is responsible for regulating vaccines. In situations when there is good scientific reason to believe that a vaccine is safe and is likely to prevent disease, the FDA may authorize its use through an Emergency Use Authorization (EAU) even if definitive proof of the efficacy of the vaccine is not known, especially for diseases that cause high mortality.

This is where they caught us; they used emergency measures to push out a drug that they “believed’ to be safe.

So, my question to you community is, how do you feel about being injected with something that scientifically takes 10-15 years to develop safely, but is now being condensed to a 100 day process?

Feel free to comment, and let us know