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., who 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”

HPV vaccine, autonomic dysfunction – another large study finds no links

HPV vaccine autonomic dysfunction

A recent large, comprehensive study provides evidence that there are no links between the HPV vaccine and autonomic dysfunction. Researchers keep looking for serious adverse events after individuals receive the HPV vaccine, and they keep finding nothing.

I know that I keep presenting new articles that establish the safety and effectiveness of the HPV vaccines – I bet it seems repetitive. But we need to keep making certain that everyone knows that the HPV vaccine is extremely safe, and it prevents cancer. 

Well, let’s take a quick look at this new study, so we can have it in our figurative back pocket when we here the newest anti-vaccine claim that the HPV vaccine and autonomic dysfunction is linked. It isn’t. Continue reading “HPV vaccine, autonomic dysfunction – another large study finds no links”

Dorit Rubinstein Reiss – an index of her vaccine articles on this website

Dorit Rubinstein Reiss

Dorit Rubinstein Reiss – Professor of Law at the University of California Hastings College of the Law (San Francisco, CA) – is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines (generally, but sometimes moving to other areas of medicine), social policy and the law. Her articles usually unwind the complexities of legal issues with vaccinations and legal policies, such as mandatory vaccination and exemptions, with facts and citations.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination–she really is a well-published expert in this area of vaccine policy, and doesn’t stand on the pulpit with a veneer of Argument from Authority, but is actually an authority. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

She was also one of the many contributors to the book, “Pseudoscience – The Conspiracy Against Science.”

Many bloggers and commenters on vaccine issues will link to one or more of her articles here as a primary source to counter an anti-vaccine claim. The purpose of this post is to give you a quick reference to find the right article to answer a question you might have.

Below is a list of articles that Dorit Rubinstein Reiss has written for this blog, organized into some arbitrary and somewhat broad categories for easy reference. This article will be updated as new articles from Professor Reiss are published here. We also may update and add categories as necessary.

Because she has written over 160 articles for this website, there is a vast amount of information about vaccines and the law, I have created a search engine that allows you to quickly find a specific article written by Professor Reiss on this website by using any keywords that you want. This should help speed up your search for just the right article that she has written.


Continue reading “Dorit Rubinstein Reiss – an index of her vaccine articles on this website”

Trump coronavirus vaccine – in this one specific case, I’m anti-vax

trump coronavirus vaccine

As I’ve discussed previously, the FDA may use its Emergency Use Authorization (EUA) powers to push the Trump coronavirus vaccine out on the citizens of the USA before it’s been fully tested. Using Vladimir Putin’s example of pushing out a vaccine before it’s fully tested, Donald Trump keeps insisting that we’ll get a new COVID-19 vaccine soon, well before phase 3 clinical trials are done.

All vaccines currently on the market have been tested thoroughly. And the science that these current vaccines are very safe and very effective is settled. I am thoroughly convinced of the evidence that we have excellent vaccines, so it is clear that I am thoroughly pro-vaccine – I do not have to convince anyone of that.

However, for the Trump coronavirus vaccine, I am anti-vaccine. But it is a very narrow, very unique situation. 

I have been troubled by the speed of the coronavirus vaccine research. I think it can lead to a bad vaccine on the market. Recently, Astra-Zeneca had to put a hold further testing of the so-called University of Oxford vaccine, because of a suspected serious adverse event in one individual. Astra-Zeneca will investigate the adverse event to determine if the vaccine caused it.

This is not uncommon in clinical trials – there is an abundance of caution while investigating new drugs, despite what people believe about how clinical trials are managed. That’s why vaccine research is difficult and not a slam dunk. 

On the other hand, there will be serious consequences to a rushed Trump coronavirus vaccine, because we might not get these safety signals that can appear in large clinical trials. And if we do this wrong by avoiding large phase 3 clinical trials, people who may be on the fence about vaccines become convinced by anti-vaxxers that this awful process was used by all other vaccines. It wasn’t.

Dr. Peter Hotez, MD Ph.D., one of the leading vaccine scientists in the world,  posted a Twitter thread where he discussed his concerns about a potential Trump coronavirus vaccine.

I want to review each of the 12 concerns he posted along with my own opinions on each. Continue reading “Trump coronavirus vaccine – in this one specific case, I’m anti-vax”

ACIP COVID-19 vaccines meeting – summary of August 2020 discussions

This article about the August 2020 ACIP COVID-19 vaccines meeting was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

On August 26, 2020, the Advisory Committee on Immunization Practices (ACIP) held an emergency meeting to discuss COVID-19 vaccines. This was an emergency meeting, as opposed to one of its three annual scheduled meetings, but it was not “emergency” in the sense of being unplanned – it was announced long in advance, and the announcement was repeated during the June and July emergency meetings.

The ACIP COVID-19 vaccines meeting consisted of four to five hours of presentations from the COVID-19 vaccines workgroup, convened in April, and one hour of public comments that included multiple pro-vaccine speakers and four anti-vaccine individuals.

The main takeaway most people would have from the meetings are, I expect, the same as mine – that COVID-19 vaccines safety is taken extremely seriously by the workgroup and the committee, that there is still a lot of uncertainty about which of the vaccine in the pipeline will be effective, and that there are thorny, hard questions in deciding how to allocate the first vaccine doses.

This will be a very short overview of the meeting. The next meeting is on September 22, and I encourage and urge people to listen and learn from it. The presentation slides for the previous meetings can be found here. Continue reading “ACIP COVID-19 vaccines meeting – summary of August 2020 discussions”

Catie Clobes – legal harassment from an anti-vaccine activist – Take 10

This article, about anti-vaccine activist Catie Clobes legal actions against Karen Ernst, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease

It is not unusual to observe anti-vaccine activist harassment of those who challenge their claims, by threatening legal action.  Most often, the legal threats are baseless but can seem threatening. Because such episodes are not uncommon, I have decided to describe the latest, explain why the threat it made is unfounded, and offer some guidance on what to do if you face such a threat. Continue reading “Catie Clobes – legal harassment from an anti-vaccine activist – Take 10”

Vaccine adjuvants – another misguided FOIA request from ICAN

vaccine adjuvants

This article about an FOIA request for information about vaccine adjuvants was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.

In August 2020, the anti-vaccine organization, the Informed Consent Action Network (ICAN), posted on their site a letter from the National Institutes of Health (NIH) dated July 19, 2019, under the (misleading) title that “NIH Concedes It Has No Studies Assessing The Safety of Injecting Aluminum Adjuvants.”

As in the past, ICAN’s use of the Freedom of Information Act (FOIA) request result is highly misleading, in at least three ways. First, FOIA is not a mechanism for science query, only a way to get existing administrative records, and this is a misuse of FOIA. Second, there are abundant scientific studies on the safety of aluminum vaccine adjuvants, but this request was not a way to get them. And third, even if there were no studies on the safety of aluminum adjuvants in vaccines, vaccines are tested as a whole, and the safety data on them cover all their ingredients. Continue reading “Vaccine adjuvants – another misguided FOIA request from ICAN”

CDC vaccine patents – Robert F Kennedy Jr gets this one wrong too

CDC vaccine patents

If you follow the anti-vaccine world, you will hear Robert F Kennedy Jr often claim that there are CDC vaccine patents that are so valuable that the CDC itself sets aside all morality and ethics to endorse the vaccines developed through these patents just to make more money for the CDC.

Kennedy, who once threw himself at Donald Trump in an effort to head a Vaccine Commission, has made this claim for several years now, but repeated it in an interview, stating that, “the CDC is a subsidiary of the pharmaceutical industry. The agency owns more than 20 vaccine patents and purchases and sells $4.1 billion in vaccines annually.”

Typically, Kennedy provides absolutely nothing in the form of supporting evidence. It makes no sense to argue against an imaginary claim – this is a pretty good example of an opinion rather than facts.

But along comes Ginger Taylor, one of the most ardent and science-ignoring anti-vaccine activists around these parts. In fact, she inspired my article entitled, Vaccines and autism science say they are unrelated

Taylor, who apparently has an autistic child, believes that vaccines “damaged” her child because, as a mother, she knows more than actual scientists. She considers science to be an elitist pursuit, it’s not data and evidence that matter but only her opinion.

Seriously, Taylor has an utter lack of self-awareness, which apparently broke one of Orac’s favorite Big Pharma Irony Meters™. Her opinion of her own scientific knowledge, i.e. her Dunning-Kruger cognitive bias, is betrayed by the reality of the vast mountain of scientific knowledge supporting the safety and effectiveness of vaccines.

So this same Ginger, the vaccine-denier that she is, decided to write an article with another torturous description of the CDC vaccine patents conspiracy theory, trying to support Kennedy’s outlandish claims. And she wrote this article in GreenMedInfo, one of the most ignorant anti-science websites on the interwebs, just a bit below NaturalNews in quality.

The problems with Taylor’s article are multi-fold – but generally, like so many other anti-vaccine zealots, they think they know a lot about a topic based on their 15 minutes of Google search time, rather than doing the tens of thousands of hours of actual vaccine research using science.

Taylor is utterly uneducated about and inexperienced with not only science but also patents – she gets nearly everything about her conspiracy theory totally wrong. 

So here we go, debunking the anti-vaccine myth of the CDC vaccine patents. Continue reading “CDC vaccine patents – Robert F Kennedy Jr gets this one wrong too”

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”

HPV vaccine effectiveness – 14 year follow-up of women, all good news

HPV vaccine effectiveness

Despite all that’s going on with the coronavirus pandemic, great studies about important subjects as HPV vaccine effectiveness continue to be published. And this study, which followed Nordic women for 14 years, continues to show us that the HPV vaccine is safe and effective.

So let’s take a moment to review this new article about HPV vaccine effectiveness, so that you have more evidence to support the value of the vaccine. Continue reading “HPV vaccine effectiveness – 14 year follow-up of women, all good news”