Wednesday, October 7, 2020

The Food and Drug Administration - Gatekeeper for a COVID-19 Vaccine

Governments around the world are counting on a pharmaceutical solution to the COVID-19 pandemic.  Here is an industry tracker showing how many vaccines and therapeutic drugs are in trials for COVID-19:


Apparently, Big Pharma is spending untold billions of dollars and millions of hours of research on the potential for massive profits (our health be damned).  Now, let's look at one little-discussed aspect of the hunt for a coronavirus vaccine that has received relatively little coverage.


Back in June, the U.S. Food and Drug Administration released this on its website:



Let's look at some key excerpts from the FDA's Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry document.  Here is the introduction:



The key takeaway is that the FDA is, in large part, only providing vaccine manufacturers with suggestions and recommendations where it uses the word "should", not legally enforceable responsibilities.


That said, here are the general "recommendations" and "suggestions" that the FDA has for COVID-19 vaccine manufacturers:


During the manufacturing process, all source material including cell banks, virus banks and identification of all animal-derived materials used for cell culture and virus growth must be adequately controlled.  As well, complete details of the manufacturing process must be provided.  In contrast, a quality control system "should" be in place for all stages of manufacturing and testing.


One of the greatest concerns about a coronavirus vaccine is that no vaccine for a coronavirus, particularly SARS and MERS has been developed to this point in time as shown in this quote from "Vaccines for SARS-CoV-2: Lessons from Other Coronavirus Strains" by Eriko Padron-Regalado on the National Institutes of Health website:


"The emergence of the strain of coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) and its impact on global health have made imperative the development of effective and safe vaccines for this lethal strain. SARS-CoV-2 now adds to the list of coronavirus diseases that have threatened global health, along with the SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) coronaviruses that emerged in 2002/2003 and 2012, respectively. As of April 2020, no vaccine is commercially available for these coronavirus strains."

The FDA has noted this in its guidance document:

"Vaccine-Associated Enhanced Respiratory Disease" or VAERD is a phenomenon that occurs when there is an interaction between a vaccine and a respiratory disease.  Vaccine-induced antibodies appear to play a role in exacerbating respiratory symptom.  During the 2009 H1N1 pandemic, Canadian researchers found that there was a greater risk of H1N1 infection among those that had been vaccinated against seasonal influenza.  This could also occur with a new experimental vaccine for the SARS-CoV-2 virus. 


Now, let's look at the most interesting part of the guidance:


To help you understand what the highlighted portion of the page means, here is an explanation of a clinical trial:


"Clinical researchers work to ensure that they avoid bias in clinical trials. Bias refers to human choices or other factors (unrelated to the protocol) that might affect the trial's results. For example, if doctors could choose which patients to assign to comparison groups in a study, some might assign sicker patients to the treatment group and healthier patients to the control group (not receiving treatment). The doctors might not even realize they are doing this, and it could affect trial results.


Randomization helps ensure that researchers don't introduce bias into the trial. In many clinical trials that test the effectiveness of a medication, half of the participants receive the medication in question. The other half receive a placebo, which contains no medication. Randomization involves assigning patients to these comparison groups by chance, rather than choice.


Researchers also may use “blinding” to help avoid bias. In a blinded trial, researchers will not know which patients are receiving treatment and which ones are receiving a placebo."


Here is an explanation of the "placebo effect" and how powerful it can be:


"For years, a placebo effect was considered a sign of failure. A placebo is used in clinical trials to test the effectiveness of treatments and is most often used in drug studies. For instance, people in one group get the tested drug, while the others receive a fake drug, or placebo, that they think is the real thing. This way, the researchers can measure if the drug works by comparing how both groups react. If they both have the same reaction — improvement or not — the drug is deemed not to work.

More recently, however, experts have concluded that reacting to a placebo is not proof that a certain treatment doesn't work, but rather that another, non-pharmacological mechanism may be present.

How placebos work is still not quite understood, but it involves a complex neurobiological reaction that includes everything from increases in feel-good neurotransmitters, like endorphins and dopamine, to greater activity in certain brain regions linked to moods, emotional reactions, and self-awareness. All of it can have therapeutic benefit. "The placebo effect is a way for your brain to tell the body what it needs to feel better," says Kaptchuk.

But placebos are not all about releasing brainpower. You also need the ritual of treatment. "When you look at these studies that compare drugs with placebos, there is the entire environmental and ritual factor at work," says Kaptchuk. "You have to go to a clinic at certain times and be examined by medical professionals in white coats. You receive all kinds of exotic pills and undergo strange procedures. All this can have a profound impact on how the body perceives symptoms because you feel you are getting attention and care.'"

It is interesting to note that the Food and Drug Administration is requiring that a drug that will be used to prevent COVID-19 only has to be 50 percent more effective than a placebo (i.e. if a placebo is 25 percent effective, a COVID-19 drug only has to be at least 50 percent more effective (37.5 percent effective) than the placebo.

Once the subjects are being tested, since there could be some adverse reactions to the new drugs, the FDA recommends the following safety considerations:


"1.) Solicited local and systemic adverse events for at least 7 days after each study vaccination in an adequate number of study participants to characterize reactogenicity (including at least a subset of participants in late phase efficacy trials).


2.) Unsolicited adverse events in all study participants for at least 21–28 days after each study vaccination.


3.) Serious and other medically attended adverse events in all study participants for at least 6 months after completion of all study vaccinations. Longer safety monitoring may be warranted for certain vaccine platforms (e.g., those that include novel adjuvants).


4.) All pregnancies in study participants for which the date of conception is prior to vaccination or within 30 days after vaccination should be followed for pregnancy outcomes, including pregnancy loss, stillbirth, and congenital anomalies.


Let's close with this interview on a potential COVID-19 vaccine from the imminent Dr. Anthony Fauci (starting at the 4 minute 40 second mark and :


Let's repeat that.  "There's never a guarantee that your vaccine will be safe and effective".

Now, go to the 14 minute and 38 second mark where Dr. Fauci is asked how long the vaccine protection will last and whether you will need to be revaccinated  Here is his answer:

"We do not know the answer to that....You can assume that you will get protection to at least take us through this cycle....We have to assume that (the degree of protection) it is going to be finite.  Right now, we do not know how long it (immunity) lasts."

That's reassuring, isn't it?  Just what we all wanted; to be candidates for a massive vaccine experiment thanks to Big Pharma and its profit-generating business model.

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