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.
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”
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.
— 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. Continue reading “Trump coronavirus vaccine – in this one specific case, I’m anti-vax”
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. Continue reading “Coronavirus vaccine warp speed – Scotty screaming at Captain Bonespurs”
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. Continue reading “Coronavirus vaccine development – it’s going to take a long time”
Because of the ongoing COVID-19 pandemic, the interest in coronavirus vaccines has been quite high (to say the least). I have been keeping an updated list of vaccine candidates in another article, but it was becoming so cumbersome to update, and I wanted to make information clearer to read, I decided to completely rewrite it.
This article about coronavirus vaccines will also be regularly updated, so stay tuned. Continue reading “Coronavirus vaccines – massive list of vaccine candidates for COVID-19”
The locations of the current US measles outbreak (or epidemic) was predicted by researchers in an article recently published in Lancet Infectious Diseases. The amazingly prescient predictions were not based on magic, but on a scientific analysis of two factors – the vaccination rate and international travel tendencies by county in the United States.
And the statistical website, Five Thirty-Eight, took the predictions and listed out what happened during this US measles outbreak. The predictions were spot on.
Time to look at this study and its predicted results.
I have three daughters, and my oldest one, we’ll call her Catherine, was diagnosed with autism spectrum disorder many years ago. This is our story, one that has little to do with vaccines, except that I never once thought that there was a relationship between her autism and vaccines. Not once.
I have rarely mentioned Catherine online not because I was ashamed of her autism – she deserved her privacy, and I did not want to be someone who used my personal life story as a “cause” for the science of vaccines.
Then, two things happened. First, while commenting on an article I wrote a few years ago, someone said: “you don’t understand autism because you do not have autistic children.” The former statement is false because it doesn’t take having an autistic child to understand autism. The latter statement is also false because I do have a child with autism.
Second, I finally read Peter Hotez’s book, Vaccines did not Cause Rachel’s Autism. For those of you who don’t know Dr. Hotez, he is one of the leading researchers in vaccines, and he has written hundreds of peer-reviewed papers on infectious diseases (and vaccines) along with numerous books on infectious diseases. He is a real authority on vaccines, public health, and vaccine-preventable diseases, and as they said on Wayne’s World, “we are not worthy!”
So, I was inspired to write my own story, because it’s important for me on this Father’s Day 2019. And because of my acceptance of the science that rejects a link between vaccines and autism is not just academic, it is personal.
I’m a big fan of the CBS TV show Madam Secretary, which is a drama about a fictional Secretary of State, played by Téa Leoni. The most recent episode, “The Common Defense,” centered on several stories surrounding a measles outbreak in several countries – measles played the show’s villain (instead of Russian oligarchs, terrorists, and incompetent Congressman and Senators).
I was caught by surprise by the episode. At first, I thought they would mess up the science, or, even worse, take an anti-science approach to measles and vaccines. But I was pleasantly surprised, and it stated scientific facts about vaccines, though maybe I could nitpick here and there. I won’t. Continue reading ““Madam Secretary” fights anti-vaccine propaganda with facts”