JNJ COVID-19 vaccine trial – FDA rejects another ICAN petition

JNJ vaccine clinical trial

This article about the Informed Consent Action Network’s petition to halt the JNJ COVID-19 vaccine trial was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law

This is a summary of the FDA’s response to a citizen petition dated October 16, 2020, filed on behalf of the petitioner, Del Bigtree’s Informed Consent Action Network (ICAN), relating to the clinical trial of Ad26.COV2S, a Janssen Biotech, Inc. (a subsidiary of Johnson & Johnson, JNJ) COVID-19 vaccine.

Like a previous ICAN petition about COVID-19 vaccine trials, the FDA denied the petition in its entirety. FDA concluded that the vaccine trials were thorough, vaccine safety was carefully tested and monitored, and ICAN’s requests are not well-founded. 

This summary is divided into three parts: (1) ICAN’s specific requests; (2) FDA’s description of the vaccine process and safety; and (3) FDA’s response to six specific requests. 

Continue reading “JNJ COVID-19 vaccine trial – FDA rejects another ICAN petition”

COVID-19 vaccine trials – FDA rejects ICAN petition to stop the trials

COVID-19 vaccine trials

This article about the Informed Consent Action Network’s petition to halt COVID-19 vaccine trials was written by Viridiana Ordonez, a J.D. candidate at the University of California, Hastings College of Law

This article summarizes the FDA’s response to Del Bigtree’s ICAN’s (petitioner) request regarding the Phase III trials for the COVID-19 vaccine.  The summary is divided into three parts:

  1. Petitioner’s Request;
  2. FDA’s description of vaccine process; and
  3. FDA’s response to the petition.


ICAN’s request for COVID-19 vaccine trials

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Bell’s palsy and COVID-19 mRNA vaccines – let’s temper the concerns

Bell's palsy

A new issue has arisen with the Pfizer and Moderna COVID-19 mRNA vaccines – Bell’s palsy, a type of facial paralysis. The FDA has issued a “staff report” on Tuesday, 15 December 2020, that recommends monitoring people who receive those vaccines be monitored for the condition.

As I wrote earlier about the Moderna COVID-19 vaccine facts, there were a few reports of the condition after vaccination. However, we need to examine the situation carefully, so that we all have accurate information about the seriousness (or lack thereof) of this risk.

So, let’s dive into this.

Continue reading “Bell’s palsy and COVID-19 mRNA vaccines – let’s temper the concerns”

Create an independent FDA, CDC – new COVID-19 vaccines required it

independent CDC FDA

The COVID-19 pandemic and the subsequent rush for treatments and vaccines for the virus have renewed calls for a more independent FDA and CDC. Professor Dorit Rubinstein Reiss, who is a frequent contributor to this space, has written two powerful articles arguing for an independent CDC and FDA.

If you have followed the progression of the COVID-19 pandemic in the USA, the Centers for Disease Control and Prevention (CDC) and the United States Food and Drug Administration (FDA) responses have been politicized to the point that even those of us who have strongly supported those two agencies are appalled. 

The CDC has been pushed to scrub information and data to make the Trump administration look good. Recently, it was reported that one of Trump’s minions tried to pressure CDC regarding the transmission of the virus to kids to get it in line with the nonsense being pushed during Trump’s failed presidential campaign.

And then the FDA gave Emergency Use Authorizations (EUA) to hydroxychloroquine and remdesivir for treatment of COVID-19. Unfortunately, the data showed that hydroxychloroquine does not work and remdesivir has only a marginal effect on outcomes. In each case, it appears that the FDA was more interested in promoting these drugs to support President Trump’s wild claims that he was “doing something” about the pandemic, rather than relying upon robust science.

Professor Reiss has written two articles about how we might create a more powerful and independent FDA and CDC by utilizing the types of structures of actual independent agencies within the Federal Government. I want to quickly review what she proposes because I think it’s a conversation that we hope that President-elect Joe Biden might embrace during the next few years.

The problem is that 

Continue reading “Create an independent FDA, CDC – new COVID-19 vaccines required it”

FDA approved remdesivir for coronavirus – what this means for a vaccine

FDA approved remdesivir

On 22 October 2020, the FDA approved remdesivir from Gilead Sciences to treat COVID-19. Remdesivir is a broad-spectrum antiviral that has shown some effect in treating the novel coronavirus.

However, does this mean that the FDA approval of the drug is supported by good science? As I’ve written previously regarding rushed approvals of a potential COVID-19 vaccine, we should be concerned that the FDA has become politicized to approve COVID-19 drugs to make Donald Trump look good.

I think there’s evidence that the FDA-approved remdesivir was rushed and that the evidence supporting its use in COVID-19 treatment may be vastly overstated. Continue reading “FDA approved remdesivir for coronavirus – what this means for a vaccine”

Vaccine development process in the world of a coronavirus pandemic

Back before the world of the COVID-19 pandemic, the vaccine development process took a long time. Despite the nonsensical claims of the anti-vaccine zealots, the vaccine development process was robust and thorough. The safety and effectiveness of all of the pre-pandemic vaccines are settled science (read the article before you jump up and down screaming about “settled science”).  

However, the world of the coronavirus pandemic means that if we can save a few months or even years off the development timeline on a new COVID-19 vaccine, it could save hundreds of thousands of lives. This does not mean those political agendas like we’ve seen Trump do with hydroxychloroquine and other things should take precedence over good science. 

So, this article is going to lay out how, in a world without a pandemic, the coronavirus vaccine development process should proceed while ignoring how the politically-driven FDA may subvert the process

Although I am very uncomfortable with the coronavirus vaccine development process over the past few months, it looks like, for better or worse, we’ll probably have one or two different vaccines in unknown quantities by early 2021. 

Of course, much of the optimism comes from experts like Dr. Anthony Fauci, one of the few rational public health experts who are willing to speak up in Washington DC. Maybe he has seen some secret data only available only to him and Bill Gates that supports this optimism. Maybe he just is trying to be the national cheerleader for healthcare.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, like Dr. Peter Hotez, MD Ph.D., has expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the development process, along with the independent controls that make sure that all vaccines are safe and effective.

Continue reading “Vaccine development process in the world of a coronavirus pandemic”

Coronavirus vaccine EUA? Bad science from a desperate president

coronavirus vaccine EUA

Because of recent emergency use authorizations (EUA) from the FDA, there is trepidation that they will approve a coronavirus vaccine EUA to make a big splash for a desperate Donald Trump. This is unsettling to those of us who are “pro-vaccine,” because it could cause hesitancy towards this vaccine, and frankly, all vaccines, to skyrocket.

Democrats in Congress are trying to make sure that a coronavirus vaccine EUA does not endanger the health of the country or cause Americans to become even more vaccine-hesitant. So, this article will examine what is and is not a part of an emergency use authorization. And what this all means for a potential coronavirus vaccine EUA. Continue reading “Coronavirus vaccine EUA? Bad science from a desperate president”

Coronavirus vaccine race – Operation Warp Speed could be a disaster

coronavirus vaccine race

Donald Trump has recently pushed “Operation Warp Speed” that will speed the coronavirus vaccine race so that we can have a new COVID-19 vaccine by January 2021. This is could end up being a disaster.

This is like the hundredth article I’ve posted on coronavirus vaccines. I just joked with someone that if I wrote an article that conclusively established that aluminum adjuvants in vaccines actually cured cancer, erectile dysfunction, and the inability to hit an inside curveball, the first 30 comments posted at the end of that article would ask, “yeah that’s nice to know, old dinosaur. But does it cure COVID-19?”

Even Dr. Anthony Fauci, whose facial expressions in response to whatever lie that Donald Trump is saying during his daily coronavirus campaign events are meme-worthy, has also said that we might see a vaccine within 12-18 months. Now, Dr. Fauci is a billion times smarter than I ever will be about immunology, infectious diseases, and baseball, but I have numerous reservations about this aggressive timeline. 

Maybe Dr. Fauci has some inside knowledge. Maybe he has seen some secret data only available only to him and Bill Gates. Maybe Trump has a gun pointed at him during these press briefings (really, campaign rallies). 

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines are very skeptical of this aggressive timeline for a new COVID-19 vaccine. I consider myself a pharmaceutical development expert, and I am unconvinced that this coronavirus vaccine race can be done safely. Continue reading “Coronavirus vaccine race – Operation Warp Speed could be a disaster”

Coronavirus vaccine testing – pro-vaxxers want to “take a risk” with testing

coronavirus vaccine testing

Time for something completely different – I keep reading statements by pro-vaccine people that they want to shorten coronavirus vaccine testing to get it out to the people faster. Let me slam on those brakes because nothing could be worse for public health than to engage in that type of thinking.

As I’ve written on a number of occasions, coronavirus vaccine testing is going to take a long time. Publicly, some “experts” are claiming that a vaccine might take 18 months, but that’s only if everything goes right. And since it always doesn’t go right, I would bet that it would take 4-5 years before we see a coronavirus vaccine.

Because of this pandemic has become very dangerous, and there are no “cures” right now (despite Donald Trump’s ignorance about chloroquine), the desire for a vaccine has become very loud and very annoying. 

But to speed up coronavirus vaccine testing is dangerous. And let me explain why. Continue reading “Coronavirus vaccine testing – pro-vaxxers want to “take a risk” with testing”

COVID-19 vaccine research for coronavirus – updated 26 March 2020

COVID-19 vaccine

This article about COVID-19 vaccine research has been completely updated and can be found here. The comments section for this article has been closed.

Because the development of a potential COVID-19 vaccine is of massive interest currently, and because I have a passion for vaccine research and development, this article will a guide for vaccines involved with the coronavirus. It will be updated regularly, and I will post to social media when it is updated.

Right now, there are several COVID-19 vaccine candidates being developed by large and small pharmaceutical companies. Of course, social media will make it sound like they are all just around the corner, and they will all work.

It doesn’t work that way, so let me keep you updated with this guide to COVID-19 vaccine research and development. Continue reading “COVID-19 vaccine research for coronavirus – updated 26 March 2020”