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”

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”

COVID-19 vaccines – rampant myths as annoying as Del Bigtree’s claims

COVID-19 vaccines

I have tried to answer questions across the internet about COVID-19 vaccines, but it is getting frustrating. Some of these fantasies are as amusing and annoying as any of Del Bigtree’s ignorant claims about any vaccine on the market. 

Although I have written an article, which is regularly updated, about coronavirus vaccine development, apparently people want to believe that there are miraculous, magical COVID-19 vaccines just around the corner. 

Here’s a list of FAQs debunking some of the most pernicious myths about COVID-19 vaccines. Continue reading “COVID-19 vaccines – rampant myths as annoying as Del Bigtree’s claims”

Coronavirus quacks get smacked down by the FDA – grifters keep grifting

Because of the COVID-19 pandemic, the internet is filled with coronavirus quacks who make all kinds of unsubstantiated and dangerous claims about useless treatments. Enter the FDA to give many of them a good, old-fashioned smackdown.

Right now, there is no official protocol for treating the disease, but China, which has the most cases, researchers reported the majority of patients received IV antibiotics to treat secondary infections (it does nothing to the coronavirus). Most patients have also been treated with antiviral oseltamivir (Tamiflu), which is FDA approved to treat influenza, as well as supplemental oxygen.

Of course, the coronavirus quacks, who wouldn’t know much about evidence-based medicine, are pushing expensive, but useless, treatments for COVID-19. And the FDA couldn’t take it anymore. Continue reading “Coronavirus quacks get smacked down by the FDA – grifters keep grifting”

Argument by Vaccine Package Inserts – they’re not infallible

vaccine package inserts

One of the cherished strategies of the anti-vaccine religion is to quote vaccine package inserts (called a Patient Information Leaflet in EU countries and Instructions for Use in other areas) to “prove” that vaccines are dangerous. These vaccine deniers consider the package insert to be the golden tablets of the Truth™.

Yes, it is cynical that these anti-vaccine groupies rail against Big Pharma as if they are demon reptilians, but the package insert, written by Big Pharma, is considered gospel. And there is another broken irony meter.

Just spend more than a couple of minutes in discussion in any vaccine “debate,” and you’ll eventually get someone pointing to a section in any of the many vaccine package inserts (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary. Or that it doesn’t work.

The snarky Orac has proclaimed it “Argument by Package Insert” – it’s almost at the level of logical fallacy. David Gorski has just given it the Latin name, argumentum ad package insert, so it’s now officially a logical fallacy, at least for vaccine discussions.

Before we start, vaccine package inserts are important documents, but only if the information included therein is properly understood. However, vaccine package inserts are not documents that serve as medical and scientific gospel. But it is a document that can help clinicians use vaccines (or frankly, any medication) properly. Continue reading “Argument by Vaccine Package Inserts – they’re not infallible”

Testing vaccines for cancer – another anti-vaxxer myth with no credibility

testing vaccines

If you’re spending more than a nanosecond reading idiotic memes from the anti-vaccine religion, I’m sure you’d see the old the package insert says that FDA doesn’t require testing vaccines to determine whether they cause cancer or not. It still makes me laugh how much authority the anti-vaxxers give to package inserts, but that’s another story for another day.

Oh wait, it is another story that I told. You know, the old argument by vaccine package insert fallacy. It’s a fun one, it’s helpful in dismissing the bogus claims that the anti-vaxxers make using package inserts.

Like all zombie memes from the vaccine deniers, this one keeps disappearing then returning every few months. And now with the current measles epidemic in the US and other areas, it’s arisen from the graveyard of debunked vaccine myths to haunt the internet. 

And it’s time to debunk it once again. Continue reading “Testing vaccines for cancer – another anti-vaxxer myth with no credibility”

MMR vaccine is safe and effective according to powerful FDA statement

MMR vaccine

As many of you are aware, there is an ongoing measles epidemic in the USA (an Europe), which has struck over 600 Americans in 2019, nearly double the 2018 numbers. The best and only way to prevent measles is with the MMR vaccine against measles, mumps, and rubella

Credible, robust, and repeated peer-reviewed published evidence has conclusively established that there is no link between the MMR vaccine and autism, This is settled science.

Despite this overwhelming scientific evidence, the outrageous deceptions and lies of the anti-vaccine religion, starting with that cunning fraud, Andrew Wakefield, continue to scare parents from giving their children the MMR vaccines. The World Health Organization (WHO) has stated that vaccine hesitancy is one of the top 10 threats to global health. Continue reading “MMR vaccine is safe and effective according to powerful FDA statement”