Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases under the National Institutes of Health, told NPR in a one-on-one interview that it was “conceivable” America could start to produce for consumer use a vaccine for the coronavirus by the end of the year, and that if so, it would be a vaccine that would be “safe” to administer.
Absurd and false.
And Americans concerned about their health should consider shunning this shot.
“Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement,” according to the HistoryOfVaccines.org, an educational website from The College of Physicians of Philadelphia.
There’s the exploratory stage, “basic laboratory research” that “often lasts 2-4 years,” the website reported.
There’s the pre-clinical stage, involving “animal subjects” like “mice and monkeys,” that “lasts 1-2 years,” the website reported.
There’s the application stage, where the vaccine sponsor — “usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration,” that carries a 30-day approval deadline for the FDA, the website reported.
And then come the trials.
The Centers for Disease Control and Prevention explains the process for vaccine approval as a similarly complex and lengthy process that — as HistoryOfVaccines.org reported — starts with the exploratory and pre-clinical states, moves into clinical development, and then to regulatory review and approval, manufacturing and quality control.
But “clinical development is a three-phase process,” CDC wrote.
There’s Phase I, where just a small grouping of people get the vaccine.
There’s Phase II, where medical professionals administer the vaccine to the targeted group — the targeted ages, the targeted physical health, etc.
There’s Phase III, where thousands of people get the vaccine, and the government keeps a tight check on side symptoms and adverse effects.
Moreover, CDC reports, “many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.”
The whole process takes, well, forever.
“In the United States, vaccine development and testing follow a standard set of steps,” HistoryOfVaccines.org wrote. “Regulation and oversight increase as the candidate vaccine makes its way through the process.”
In other words: Fauci’s claim of a safe and effective vaccine for the coronavirus by year’s end is disingenuous to the point of la-la land.
“I think it is conceivable, if we don’t run into things that are, as they say, unanticipated setbacks, that we could have a vaccine that we could be beginning to deploy at the end of this calendar year, December 2020, or into January, 2021,” he said on “Morning Edition” on NPR.
He went on with this, CNBC reported: “When you’re dealing with vaccines there could be so many things that get in the way — like it might not be entirely effective. And you wouldn’t want to deploy a vaccine that’s not effective and certainly not one that’s not safe.”
Especially “not safe.”
Especially one that causes health harm to those who take it.
But then Fauci said this — and here’s where the alarm bells clang loud.
“The risk,” he said, “is not to the patient because the safety and the scientific integrity is intact. The risk is to the investment and we feel that it’s important enough to make those investments in order to save months.”
Right. Why spend the years it normally takes to develop what would normally be considered an “effective” and “safe” vaccine by normal medical, normal federal, normal health standards, when you can sell it as the same “effective” and “safe” in just a few short months?
It’s the “investments,” dontcha know.
He also quickly issued a caveat — known colloquially as a cover-your-butt remark — that went like this: ”[The December-January timeline’s] never a promise, because when you’re dealing with vaccines, there could be many things that get in the way.”
Yes. Like pesky media attention that raises uncomfortable questions and red flags.
Like alert citizens who understand how the politics of COVID-19 work.
Like independent medical professionals who don’t mind shining truth to medical power.
Regardless: The American people are not guinea pigs.
The American people shouldn’t be sold on the idea of a vaccine that’s both “effective” and “safe” when it hasn’t undergone the normal processes of determining “effective” and “safe.”
That’s not to say the government shouldn’t be full speed ahead with a vaccine for the coronavirus. By all means, go right ahead.
But it is to say the vaccine should not be mandatory. It is to say that those who do opt in ought to be given a full reckoning of the health risks they’re taking.
It is to say that claims of its safety and effectiveness are preliminary at best — false at root. There’s no way, no how, by the government’s own standards, a vaccine for the coronavirus by December or January can be called “safe” for the citizens of America.
• Cheryl Chumley can be reached at firstname.lastname@example.org or on Twitter, @ckchumley. Listen to her podcast “Bold and Blunt” by clicking HERE. And never miss her column; subscribe to her newsletter by clicking HERE.
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