Peter Hotez

COVID vaccine development process – how it compares to “normal”

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 is 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 COVID-19 pandemic meant 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, maybe millions, of lives.

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., have expressed dismay at how politics may “trump” good science.

So, this article will try to lay out the COVID-19 vaccine development process, along with the independent controls that make sure that all vaccines are safe and effective.

Vaccine development process – how it’s usually done

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.

Horse dewormer ivermectin still doesn’t work for COVID — get the vaccine

I thought I had finished writing about the horse dewormer ivermectin, but a new large study shows that it still doesn’t do anything for COVID-19. Unless you just happen to have a parasitic infection along with COVID-19, sure, it could help there.

Well, let’s take a look at this new study, just to the final nail in the coffin for using ivermectin to treat COVID-19. Who am I kidding?

Vaccine science — why I do research better than anti-vaxxers

by Michael Simpson
2022-02-08
Climate change, Diabetes, Science, Vaccines

How many times have you read a comment from an anti-vaxxer that states, “I’ve done my vaccine science research, and it says vaccines are bad.” That comment seems to imply two things – that the anti-vaxxer believes they have done real vaccine science research, and those on the science/medicine side have not done real vaccine research.

What I’ve found is that the anti-vaxxer research into vaccine science is based on their Google University education rather than actual scientific education. Vaccine science is hard, and it cannot be done in a few hours searching for unimpressive memes.

The typical anti-vaxxer understates how hard vaccine research is while overstating their actual skills and experience in comprehending real scientific research. I suppose this is a perfect example of the Dunning-Kruger effect – a cognitive bias wherein people without a strong scientific background fail to recognize their actual ineptitude in the field and mistakenly overrate their knowledge and abilities as greater than it is.

On the other hand, I’ve done real scientific research that gives me a relatively decent background in vaccine science. And I’m going to state, without any remorse, that I am no Dr. Paul Offit, Dr. Peter Hotez, or any of the hundreds of researchers at the CDC and WHO. My background in vaccines is a result of my education, which is a lot more than a few hours on Google.

Merck seeking emergency us authorization for molnupiravir, new COVID-19 drug

Pharmaceutical giant Merck announced a new drug to treat COVID-19, called molnupiravir, which appeared to cut the risk of hospitalization and death by nearly half for at-risk patients. Furthermore, Merck will be seeking an emergency use authorization for it immediately.

Although this may sound like good news, and if you are reading the news about this drug, you’d think it was a miracle, I want to make sure that everyone understands several important factors about this drug’s safety and effectiveness profile. It is not a miracle, but it may be an important addition to the treatment protocols for COVID-19 patients, especially those at the highest risk of hospitalization or death.

This is not a worthless drug, at least for COVID-19, such as the horse dewormer, ivermectin, that has become popular with the pseudoscience crowd. Molnupiravir was designed from the beginning as an anti-viral drug.

Anti-vaccine Sharyl Attkisson threatens to sue Dr. Peter Hotez for defamation

This article about threats to sue Dr. Peter Hotez by anti-vaccine journalist Sharyl Attkisson 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. She is also a member of the Vaccines Working Group on Ethics and Policy.

Litigation threats by anti-vaccine activists are not new, nor are they unusual. Recently, anti-vaccine journalist Sharyl Attkisson sent a litigation threat to Dr. Hotez, a threat she then published online. Her chances, if she actually sues, are slim, but that does not seem to be the point of such threats.

As best as I can tell, litigation threats by anti-vaccine activists serve two purposes, neither of which depending on the validity of the claims. First, towards the target of the threat, the threat can serve as a deterrent to engage with the anti-vaccine activist. Second, in relation to the anti-vaccine activist’s own followers the threats can both serve to create a narrative of victimhood (“I’m targeted by ‘them’), and second to present themselves to their followers as bravely fighting back against attacks.

This post will describe the events, then put them in the context of previous litigation threats by anti-vaccine activists and previous such behavior by Sharyl Attkisson, then make some suggestions to any reader targeted by similar threats.

Pfizer COVID-19 vaccine review scheduled for December 10 by FDA

The US Food and Drug Administration (FDA) has announced a Pfizer COVID-19 vaccine review meeting for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 10 December 2020. It is intended to discuss and review the emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine.

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

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.

1/13: New Thread: A dozen reasons why I'm worried about releasing a #COVID19 #vaccine through an emergency use authorization (EUA)

— Prof Peter Hotez MD PhD (@PeterHotez) September 2, 2020

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

Coronavirus vaccine warp speed – Scotty screaming at Captain Bonespurs

The coronavirus vaccine warp speed project from old Bonespurs, aka President Trump, is causing Scotty to yell, “Aye, the haggis is in the fire now for sure.” Operation Warp Speed is moving ahead at full power with not a single Starfleet Officer of note on board.

Not on board with the Star Trek metaphors?

Well, the coronavirus vaccine warp speed operation is President Bonespurs’, I mean Trump’s, new task force that will bring us a new vaccine in a matter of months. That’s not going to happen in any case, especially when the President Bonespurs, OK, Trump, didn’t add any of the country’s top vaccine researchers to the task force.

Instead, he opted for industry hacks who have made some curious choices on the top vaccine candidates to support. Let’s take a look at the coronavirus vaccine warp speed directive.Read More »Coronavirus vaccine warp speed – Scotty screaming at Captain Bonespurs

Coronavirus vaccine development – it’s going to take a long time

I keep reading this belief, over and over, that by some miracle, coronavirus vaccine development will only take “12-18 months.” Like a lot of things in life, we keep repeating that mantra, but when anyone tries to find any veracity in that claim, there’s little there.

I know 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?”

But the common theme I keep hearing is that coronavirus vaccine development will go super fast, and we’ll have that vaccine in 12-18 months. Then we can go back to fun times like watching that inside curveball at a baseball game, scaring away wildlife at our National Parks, and sitting in our friendly diner consuming thousands of calories.

Even Dr. Anthony Facui, whose facial expressions in response to whatever lie that Donald Trump is saying during his daily coronavirus campaign events are meme-worthy, has said that we might see a vaccine within 12-18 months. Now, Dr. Fauci is a billion times smarter than this old raptor, but I am very skeptical.

Maybe he 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 campaign rallies. Or maybe he just believes it because he’s an optimistic person, and he doesn’t want people to give up knowing that it could take three or more years for a vaccine.

I don’t know the real answer, but a lot of vaccine experts who have spent their lifetime studying vaccines, and they are very skeptical of this aggressive coronavirus vaccine development timeline.

I know I’ve been repeating myself over and over and over about coronavirus vaccine development, but I just think that we’re doing a disservice to public health by placing bets on a COVID-19 vaccine being out there any time within that timeframe. Read More »Coronavirus vaccine development – it’s going to take a long time