Wednesday, July 29, 2020

Challenge Trials - The Ethics of Human Trials for a COVID-19 Vaccine

While it received almost no coverage in the mainstream media, a publication by the World Health Organization dated May 2020 is particularly frightening given the unprecedented rush to create a vaccine for the SARS-CoV-2 virus.

Here are quotes from an article that appeared on the Financial Times website on May 9, 2020:

"Francis Collins, director of National Institutes of Health, has asked the NIH vaccines working group to “write a perspective on the scientific and practical considerations for a Covid-19 human challenge model”.

The group, which includes senior vaccine developers from universities and industry, will meet on May 11 to discuss the issue.

Challenge trials have a long history in medicine because deliberately infecting volunteers gives results more quickly than waiting for them to be infected in the community, but they are inevitably risky. 

A growing number of scientists say the world needs a Covid-19 vaccine so urgently that regulators and research funders should make preparations now, enabling human infection studies to begin after potential vaccines have completed their initial safety testing.

Around 100 Covid-19 vaccines are currently in development worldwide, with several in the early stages of clinical trials." (my bold)

While you may think that actually using the virus to deliberately infect volunteers is an unrealistic idea, here is a recent letter from several members of the United States Congress to  the Secretary of Health and Human Services and the Commissioner of the Food and Drug Administration dated April 20, 2020 with the pertinent sections regarding human trials of deliberately infected people highlighted:

Now, let's look at what the World Health Organization has to say about human trials using deliberately infected human test subjects.  The paper, entitled "Key criteria for the ethical acceptability of COVID-19 human challenge studies" (i.e. the deliberate infection of test subjects) dated May 6, 2020, again, with the pertinent sections highlighted:

The World Health Organization states that there are four benefits to challenge studies:

1.) acceleration of vaccine development.

2.) increased likelihood of selecting the most effective vaccine.

3.) validation of immunity testing.

4.) improved knowledge of SARS-CoV-2 infection and transmission.

It is also important to note that WHO recommends using healthy young adults between the ages of 18 to 30 since they are less likely to die from COVID-19.  This is actually of relatively little use since the vast majority of the people dying from COVID-19 are the elderly, particularly those in their late seventies and early eighties.

The World Health Organization also notes that challenge studies have been used in the past to accelerate the development of vaccines against typhoid and cholera, however, they neglect to note that the case-fatality rate for typhoid fever ranged from 10 percent and 30 percent and the case-fatality rate for cholera ranged from 54 percent to 68 percent, far in excess of the case-fatality rate for COVID-19.

Given this graphic which shows that the daily number of new cases of coronavirus ranges from 250,000 to nearly 300,000: has to wonder exactly why members of the United States Congress and the World Health Organization feel that it is necessary to deliberately infect human subjects with the SARS-CoV-2 virus.  Surely, the number of infected humans around the world should be sufficient for a reliable field trial of an experimental coronavirus vaccine.

While the very thought of medical experimentation on humans should send shudders down the spines of all of us, in the name of a government-ordered rush to create an unprecedented vaccine for a coronavirus, all caution is being tossed to the wind.  The rush to create a "medical COVID-19 miracle" has created an atmosphere where ethics no longer apply and human lives really don't matter.

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