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Speeding Up Vaccine Development With "Challenge Trials"

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The problem with developing vaccines is that it takes so long. For example, by the time a safe vaccine is developed for Covid 19, the pandemic will have subsided. That's what happened with the planned SARS vaccine in 2003 (another corona virus). Big Pharma didn't even start phase 3 trials for SARS because the virus disappeared before phase 3 could begin. And when the virus disappeared, so did the need for a vaccine. Big Pharma's dreams of reaping billions of dollars in profit went up in smoke.

The other problem that big Pharma faces is the increasing number of Americans who are skeptical about fast-tracking vaccines. They read about AstraZenica's vaccine trial, which began in April 2020 in Britain. Two participants in the trial developed transverse myelitis within days of getting jabbed (Bill Gates coined the term). Transverse myelitis is a permanent debilitating disease (due to a swelling of the spinal cord) similar to multiple sclerosis. The trial was temporarily halted.

But big Pharma, keeping its eyes always on the gold, has come up with a new alternative, plan.

Instead of the standard three-phase trial, that takes years to conduct and involves tens of thousands of volunteers, and millions of dollars, they plan to run what they call "challenge trials." Challenge trials can be conducted on a comparatively small number of volunteers, and the results are obtained in a very short time-in months. In other words, challenge trials can succeed where three-phase trials would fail because they can quickly be created and brought to market before the virus disappears.

The first challenge trial is scheduled to begin this January in England.1 Hundreds of English volunteers will be jabbed with a Covid-19 vaccine. A month later these volunteers will inhale coronavirus. Some time later (two weeks maybe) after inhaling the coronavirus, they will be tested with the PCR test. If 50% of the volunteers test negative, big Pharma will declare the vaccine safe and effective. Then big Pharma will race to produce the vaccine (remember they are in a race to get the vaccine to market before the virus disappears) and sell millions of doses to populations who have been suffering in lockdowns all over the world.

The volunteers will be paid between $5,000 and $6,000 for their services.

The plan has been criticized scientifically and ethically. First of all, no one would encourage older people or teenagers or children or pregnant women or people with preconditions or even middle-aged people to inhale corona virus-not even for $6,000. So the volunteers will most likely have to be young, healthy poor people, which would mean that the results of the challenge trial wouldn't prove much in terms of the general population.

Another problem is that there will be no placebo-no control group (which is the gold standard of experimental science). If, after being sprayed with coronavirus, 50% of the volunteers appear to have been protected, there would be no way to know if vaccine was working or something else was at work.

In addition, there is no approved treatment for the volunteers who get sick by inhaling the virus. Big Pharma would be making healthy people sick, perhaps watch them die, and not be able to help. They would no doubt say something like, "They knew what they were getting into when they took the money."

In order to do minimum damage, the NIH is manufacturing a special, weaker adjuvant for the challenge trial (the adjuvant is the component of the vaccine that elicits antibodies). But it still would have to be strong enough to provoke an immune response. Which brings us to another ethical problem. Should the NIH be manufacturing coronavirus at all? Haven't we learned anything yet? But we have to keep in mind that big Pharma is in a race. A race to make billions before the virus and opportunity disappears.

Ethical problems abound in the pandemic. Here's another one: Most of the young volunteers would come from people who really need the money: the unemployed; the underemployed, the poor. Will the rest of us, those who can live without a little extra money, feel comfortable jabbing the poorest people in the country with an untested vaccine, then forcing them to inhale coronavirus to see what happens?

1 Financial Times., Human Challenge trials bring vaccine a step closer; Saturday 26 September 2020, page 8

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James and Jean Anton were born and raised in New York City, and spent ten years living and working abroad in countries as diverse as Brazil, Ecuador, Denmark, Italy and Iran. They have written and illustrated books for Scholastic Inc, McGraw (more...)

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